Accepted Manuscript A Medical-Legal Review of Power Morcellation in the Face of the Recent FDA Warning and Litigation Raquel Ton, BS, Gokhan S. Kilic, MD, John Y. Phelps, MD, JD, LLM PII:
S1553-4650(15)00081-3
DOI:
10.1016/j.jmig.2015.01.017
Reference:
JMIG 2477
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 19 August 2014 Revised Date:
20 January 2015
Accepted Date: 21 January 2015
Please cite this article as: Ton R, Kilic GS, Phelps JY, A Medical-Legal Review of Power Morcellation in the Face of the Recent FDA Warning and Litigation, The Journal of Minimally Invasive Gynecology (2015), doi: 10.1016/j.jmig.2015.01.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Article Type: Review Article Corresponding Author: Mrs. Raquel Ton, BS Corresponding Author's Institution: University of Texas Medical Branch at Galveston
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First Author: Raquel Ton, BS
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Order of Authors: Raquel Ton, BS; Gokhan S Kilic, MD; John Y Phelps, MD, JD, LLM
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Craig J. Sobolewski, MD, FACOG Division of Gynecologic Specialties Duke University Medical Center Box 3609 238 Baker House, Trent Drive (courier) Durham, NC 27710 Phone: (919) 681-5788 Fax: (919) 681-5929 Email: [email protected]
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Michael Sprague MD Cleveland Clinic Florida Section of Minimally Invasive Gynecology 2950 Cleveland Clinic Boulevard Weston, FL 33331 Phone: (954) 659-5559 Fax: (954) 659-5560 Email: [email protected]
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C.Y. Liu, MD Director, Women’s Surgery Center 1604 Gunbarrel Road Chattanooga Tennessee 37421 Phone: (423) 899-6511 Fax: (423) 899-1160 Email: [email protected]
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Suggested Reviewers
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A Medical-Legal Review of Power Morcellation in the Face of the Recent FDA Warning and Litigation
The University of Texas Medical Branch at Galveston The Department of Obstetrics & Gynecology
John Y. Phelps, MD, JD, LLM 301 University Blvd. Galveston, TX 77555-0587
Fax: (409) 747-5129
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Phone: (409) 772-8598
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Corresponding Author:
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The authors report no conflicts of interest
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Email: [email protected]
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Raquel Ton, BS; Gokhan S Kilic, MD; John Y Phelps, MD, JD, LLM
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Precis: A medical-legal review to help minimally invasive gynecologists who continue to perform uterine power morcellation despite the recent FDA warning and lawsuits.
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Short Title Medical-Legal Review of Liability Risks Associated with use of Uterine Power Morcellation Devices
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Abstract
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Minimally invasive gynecological surgeons who perform laparoscopic intraperitoneal morcellation should be aware of the recent US Food and Drug Administration (FDA) warning and litigation arising from use of morcellation devices with claims of intraperitoneal dissemination of cancerous cells. On November 24, 2014 the FDA issued a statement warning against using laparoscopic power morcellators in the majority of women undergoing
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hysterectomy or myomectomy for uterine fibroids. Despite best intentions in regards to their patients, gynecologists who continue to use power morcellation devices expose themselves to liability. This article is not meant to further deter gynecologists from using laparoscopic power
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morcellators, but to provide an interpretation of the FDA statement as to which patients the use
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of power morcellators may still be permitted under the FDA guidelines. This article also offers protective measures from a legal perspective for those who choose to continue to use power morcellators in the face of the recent FDA warning and litigation.
Keywords: liability, litigation, fibroids, morcellator, morcellation, FDA, boxed warning, leiomyosarcoma, consent
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Introduction Power morcellation has allowed previously ineligible women to undergo minimally
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invasive gynecologic surgery (1). Power morcellation devices have provided a method for removing large uteri and fibroids from the peritoneal cavity without the need of a laparotomy incision. Despite the known benefits of power morcellation devices for the vast majority of
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patients, on November 24, 2014 the FDA issued the following warning to health care providers.
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Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or minilaparotomy incision (2).
The FDA estimates that approximately 1 in 350 women who have a hysterectomy or myomectomy for fibroids have unsuspected uterine sarcoma, and the risk of morcellating an
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unsuspected uterine leiomyosarcoma is 1 in 498 (3). At our institution, in response to the FDA warning the University of Texas Medical Branch in Galveston has suspended use of power morcellators, but consideration is being given to allow power morcellation in select patients with
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proper informed consent. For our institution and other institutions struggling with the question of whether to continue uterine power morcellation, informed consent is a critical issue. The purpose
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of this medical-legal review is to help gynecologists who desire to continue to use a uterine power morcellation device by providing an interpretation of the FDA statement as to which patients the use of power morcellators may still be permitted under FDA guidelines. The purpose of this article is also to discuss the legal causes of action and the importance of documenting informed consent in the medical record. Breakdown and Interpretation of the FDA Statement
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The November 24, 2014 FDA statement explicitly states use of power morcellators is contraindicated in the following:
2.
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1. Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal. Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision.
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3. Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy (2).
The FDA statement explicitly does not exclude the use of power morcellators in all patients. In the last part of their statement entitled “Recommendations for Health Care Providers” the FDA narrowly opens the door for a use of power morcellation devices in select patients (2).
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The November 24, 2014 FDA statement provides the following:
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Thoroughly discuss the benefits and risks of all treatments with patients. Be certain to inform the small group of patients for whom laparoscopic power morcellation may be an acceptable therapeutic option that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis. This population might include some younger women who want to maintain their fertility or women not yet peri-menopausal who wish to keep their uterus after being informed of the risks (2). From the FDA statement it can be implied that the use laparoscopic power morcellators are still acceptable in patients that are not peri- or post-menopausal and would need a large abdominal incision to remove their uterus and or fibroid(s) (2).
Consistent with the provisions of the FDA statement: The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should
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be shared with patients when considering surgery with the use of these devices (2). A gynecologist that chooses to continue to use a laparoscopic power morcellators should
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inform their patients of the FDA warning that cancerous cells may spread cancer and decrease long term survival.
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Leiomyomas and uterine cancer
Uterine sarcoma accounts for only 7% to 8% of all uterine cancers (4). The incidence of
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uterine sarcoma is not nearly as prevalent as other types of gynecologic cancers, with only 1,600 new cases anticipated in 2014 compared to an anticipated 52,630 cases of uterine cancer (Table 1). Uterine leiomyosarcoma only accounts for 30% of the cases of uterine sarcoma and only 1.5% of all uterine cancers (6). Leiomyosarcoma is a rare, aggressive subtype of uterine cancer. In evaluating women with leiomyomas, determining which patients may have a leiomyosarcoma
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presents a significant challenge. There are no specific symptoms or preoperative diagnostic imaging that can reliably differentiate leiomyosarcoma from benign leiomyoma. The diagnosis of leiomyosarcoma is further complicated by the fact that the appearance of leiomyosarcomas
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can mimic that of benign leiomyomas (7). For women who undergo hysterectomy for presumed
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benign leiomyomas, the estimated risk of identifying leiomyosarcoma in the extracted specimen ranges from 1 in 350 to 1 in 1,000 (8–10). The risk factors for uterine sarcoma include black race, which carries a 2 -fold higher incidence of leiomyosarcoma (11); advancing age, with a mean diagnosis age of 60 years (12); prolonged tamoxifen use ≥ 5 years (13); pelvic radiation, hereditary leiomyomatosis, and renal cell cancer (HLRCC); and childhood retinoblastoma (7). Patients can present with abnormal vaginal bleeding (56%), palpable pelvic mass (54%), and pelvic pain (22%) (7).
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The overall survival with leiomyosarcoma is poor (14). While treatment for leiomyosarcoma is largely hysterectomy and bilateral salpingo-oophorectomy, there are ongoing trials to determine the optimal treatment (7). Current comprehensive studies are underway to
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determine the impact of morcellation in patients with early stage leiomyosarcoma, compared to resection by total abdominal hysterectomy. In one study of 68 patients with surgically resectable leiomyosarcoma from 2007 to 2012, a 100% peritoneal recurrence was found in the morcellated
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group (16 patients) vs 38% in the total abdominal hysterectomy group (52 patients) (15). The authors in this study determined that morcellation as a first surgery after diagnosis decreased
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time to recurrence of leiomyosarcoma. However, the median survival of 5 years was the same in both surgical approaches (15). Leiomyosarcoma carries a 5 year survival of only 66% regardless of the stage (16). More studies are needed to determine a reliably effective adjuvant treatment for leiomyosarcoma. Due to the aggressive nature of the disease, neither radiation nor chemotherapy
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has had a significant impact on survival. In one study, a group of 225 patients diagnosed with uterine sarcoma, with no prior chemotherapy, were treated with combinations of chemotherapeutic agents as first line treatment. No significant effect on overall survival was
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observed, and leiomyosarcoma had a lower response than other types of uterine sarcoma (20% vs 33%). The authors determined that leiomyosarcoma has a poor survival rate even when treated
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with chemotherapy, and new treatment methods are needed to improve this response (17). Unlike leiomyosarcomas, endometrial cancer is easier to diagnose. Most cases present
with abnormal bleeding and can usually be diagnosed by simple endometrial biopsy (14). The incidence of endometrial cancer is higher than that of leiomyosarcomas, and while leiomyosarcomas account for 1.5% of all uterine cancers, endometrial cancer accounts for 75%–80% of all uterine cancers (6,18). The risk of endometrial cancer increases with age,
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obesity, and unopposed estrogen. The peak incidence is between 75 and 90 years, with a mean age of 66 years (14).
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Adverse Event Reports in the Manufacturer and User Facility Device Experience (MAUDE) Database
The Manufacturer and User Facility Device Experience (MAUDE) is a database for
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medical device reports submitted to the FDA by mandatory and voluntary reporters. A recent search of the database using the key words “morcellator” “morcellation” “leiomyosarcoma,” and
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“cancer” returned 31 adverse event reports, with actual event occurrences dating back to 2006 (19). One report examined the death of the reporter’s sister in 2013 following a supracervical laparoscopic hysterectomy for uterine fibroids assisted by use of a uterine power morcellator in March 2012 (19). Post operatively, it was discovered that she had uterine leiomyosarcoma. She
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underwent a second surgery 6 weeks later to remove her cervix and chemotherapy shortly thereafter. The report further claims that prior to surgery she was never informed of the possibility of uterine cancer that she might have cancer or that her uterus would be morcellated
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(19).
One report filed against Johnson and Johnson Services Inc. examined the death of a
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reporter’s wife following a vaginal hysterectomy in November 2009. According to the report, the patient had post-menopausal bleeding and a rapidly enlarging uterus, “suspicious for leiomyosarcoma (19).” The patient was referred to a gynecological oncologist who stated that the she did not “fit the profile” for uterine cancer and that “the possibility of cancer was small (19).” He recommended a laparoscopic-assisted vaginal hysterectomy with morcellation. The report states that neither verbal nor written informed consent mentioned the possibility of the spread of
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cancer cells. Following surgery, the patient presented with intestinal blockage, and new metastatic leiomyosarcoma was discovered. The manufacturer Johnson and Johnson Services Inc. was not notified of the complaint at the time, but in a later report they provided the
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following response:
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The device information for use under precautions states, caution: the use of a laparoscopic tissue extraction bag is recommended for the morcellation of malignant tissue or tissue suspected of being malignant and for tissue that the physician considers to be potentially harmful when disseminated in a body cavity. As morcellation may affect endometrial pathologic examination, preoperative evaluation of the endometrium should be considered. Should malignancy be identified, use of the gynecare morcellex tissue morcellator may lead to dissemination of malignant tissue (19).
Johnson and Johnson Services Inc. stated that safety precautions, outlining the possibility of disseminating both benign and malignant tissue, were listed on the morcellator devices (19).
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Examples of Litigation against Morcellator Manufacturers
A number of product liability suits have been filed against manufacturers of uterine power morcellation devices. In the case Salem-Robinson v Richard Wolf Med. Instruments Corp.,
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Sarah Salem-Robinson had a supracervical hysterectomy in which a morcellation device manufactured by Wolf Corporation was used (20). Prior to the patient’s surgery, there was no
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evidence of disseminated or metastatic cancer. Following the procedure, the patient was informed that one of the fibroids was a leiomyosarcoma and not a benign fibroid as previously thought. The patient was then informed that because a morcellator device was used during her surgery, there was significant risk that cancer cells had disseminated within her peritoneal cavity. Initial imaging of her lungs, abdomen, and pelvis showed no evidence of cancer. However, the patient subsequently developed 4 lesions in one of her lungs that potentially represented
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metastatic leiomyosarcoma. It is alleged that Wolf Corporation failed to warn about the possibility of dissemination of an occult uterine leiomyosarcoma throughout the peritoneal cavity and that they were aware of the risks, complications, and adverse events associated with their
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products used for uterine morcellation (20). More patients followed suit, filing similar product liability cases including Burkhart v LiNA Med. U.S. (21), Leuzzi v Ethicon Endo Surgery, Inc
verdicts.
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Example of Litigation against a Gynecologist
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(22), and Paduda v Karl Storz Endoscopy-Am., Inc (23). These cases have not yet rendered
In the case Jane Hughes v Dr. David Zisow, et al, Jane Hughes filed a lawsuit against practicing gynecologist Dr. David Zisow and Zisow Surgical, LLC claiming medical negligence (24). Jane Hughes consulted Dr. Zisow for uterine fibroids causing heavy menstrual bleeding.
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The lawsuit alleges that he recommended a hysterectomy and cholecystectomy in a combined laparoscopic procedure. According to the lawsuit, Dr. Zisow allegedly told Jane Hughes that she had a grossly enlarged, friable, 30-week-sized uterus. In 2010 Dr. Zisow performed a
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laparoscopic hysterectomy with power morcellation, and the pathology report allegedly made no mention of cancer. Two years later the patient represented with a 20 centimeter pelvic mass.
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According to the lawsuit, Dr. Zisow allegedly told the patient that the morcellator may have caused seeding of cancer and advised another surgery. The subsequent pathology report allegedly noted stage 4 leiomyosarcoma. Jane Hughes then filed suit claiming that Dr. Zisow “negligently used a morcellator suprapubically to morcellate the large uterus and remove it from the abdominal cavity,” disseminating a leiomyosarcoma. The lawsuit stated the surgery should have been completed
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without the use of a morcellator. Jane Hughes, in her lawsuit, claimed that under these circumstances, Dr. Zisow was in violation of acceptable standard of care. Based on his description of the fibroid as “large” and “friable,” it is alleged that Dr. Zisow knew he could
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have been morcellating a leiomyosarcoma (24). The lawsuit stated that standard of care requires that gynecologists not morcellate any tissue suspicious of leioymosarcoma. The lawsuit claims Dr. Zisow stated that all the fibroid tissue that could be removed was removed, but identification
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of all the tissue was difficult and some was left behind. The lawsuit also alleges that the degree of tissue destruction by morcellation made it difficult for the pathologist to make a diagnosis of
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leiomyosarcoma. According to the lawsuit, in order for Dr. Zisow to conform to acceptable standards of care, he should have removed the uterus intact so that proper pathologic identification could be made. The lawsuit further stated that if Dr. Zisow had done so, then “with reasonable medical probability, a diagnosis of leiomyosarcoma could have been made when the
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patient was in stage 1 with a 5 year survival of at least 58% (24).” Jane Hughes claims that she was never informed of the possibility of sarcoma or the possibility of seeding from the morcellator (24). This case settled prior to trial, without a finding of fault on the part of Dr.
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Zisow. Once the lawsuit was filed, the case information became available to the public.
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The new FDA, November 24, 2014, warning includes a contraindication for both perimenopausal and post-menopausal women. However, it does not adequately define perimenopause, and the peri-menopausal stage can be difficult to determine. Peri-menopause is a gray area manifested by irregular cycles, hot flashes, mood swings (25). The American College of Obstetricians and Gynecologists (ACOG) defines menopause as the absence of menstrual periods for 12 months and peri-menopause as the months or years leading up to this point and peri-menopause can last for up to 10 years (26). The FDA statement that power morcellation is
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contraindicated in peri-menopausal women does not identify a clear point in time in a woman’s life in which power morcellation may or may not be permitted.
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Review of Medical Association Statements Pertaining to Morcellation American Association of Gynecologic Laparoscopists (AAGL)
The AAGL released the following updated statement in response to the FDA guidance regarding
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power morcellation:
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The AAGL supports the FDA’s recommendation for a boxed warning to provide enhanced informed consent, however, we are concerned with the summarization of contraindications in all peri- and post-menopausal women and we agree with the American College of Obstetrics and Gynecologists that additional clarification “regarding certain language within the contraindication that could be confusing to patients and physicians” is needed. Specifically, the following information needs to be clarified: a specific definition of peri-menopausal women; the role of power morcellation in the large group of reproductive-aged women who undergo myomectomy for fertility-sparing surgery; use of power morcellation in patients with non-fibroid uteri who may have refractory uterine bleeding, prolapse or adenomyosis; guidance regarding the use of containment bags; and guidance regarding the role of non-power morcellation (use of a manual cold knife scalpel in vaginal or mini-laparotomy tissue extraction). In summary, abandoning power morcellation technology for many patients undergoing minimally invasive myomectomy, supracervical hysterectomy, or hysterectomy for a large uterus will be a setback in the care of patients with gynecologic conditions. With meticulous adherence to preoperative patient selection guidelines and informed consent, the AAGL believes appropriately performed power morcellation outweighs the risk of laparotomy in low-risk patients and is an option to be carefully considered by patients and their gynecologists (27).
American College of Obstetricians and Gynecologists (ACOG) As we have said in the past, we continue to believe that power morcellation has a role in gynecologic surgery. Power morcellation can make it possible for some women to undergo less-invasive laparoscopic hysterectomy or myomectomy, sparing them the longer recovery time and higher mortality rates associated with a total abdominal procedure. The FDA’s clarification of contraindications for morcellation will help to ensure that only women at low risk for an occult malignancy will undergo laparoscopic hysterectomy or myomectomy with morcellation. However, we look forward to working with the FDA to provide
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additional clarification regarding certain language within the contraindications that could be confusing to patients and physicians. Although the worsening of an occult malignancy as a result of power morcellation is, of course, tragic, we believe that an approach that combines deliberate patient selection criteria with robust informed consent will help protect women from a negative outcome, while maintaining access to morcellation for women who would benefit from it (28). Society of Gynecologic Surgeons (SGS)
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The society strongly advocates that gynecologic surgeons communicate clearly with patients regarding the available approaches to hysterectomy, including the risks and benefits for each technique based upon current scientific evidence. The society further advocates that surgeons maintain vigilance with regard to safety when choosing a minimally invasive approach, such as vaginal or laparoscopic hysterectomy. The SGS supports and endorses the special report of the American College of Obstetricians and Gynecologists regarding the use of power morcellation and their conclusion that the available evidence and potential benefits of morcellation do not warrant a complete ban of this technique. The society also supports the report of the AAGL task force concerning safe and efficient tissue extraction during hysterectomy (29). The Society of Gynecologic Oncology (SGO)
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To date there is insufficient prospective data to prove that morcellation results in a decrease in progression free and overall survival. Finally, as gynecologic oncologists we know that even when uterine sarcomas are removed intact there is still a very poor prognosis with these aggressive malignancies. Any assessment must recognize that the overwhelming majority of hysterectomies and myomectomies done in the U.S. are done for benign fibroids. In these circumstances intracorporeal morcellation has benefited hundreds of thousands of women. It is especially beneficial for the two-thirds of American women who are obese, and in whom laparotomy increases both morbidity and mortality. It would be a disservice to deny these or any women this surgical option. As physicians we know we must strive to never harm any one of our patients. But banning morcellation may cause more harm to more women. Thus, the Society of Gynecologic Oncology’s position is that power morcellation with appropriate informed consent should remain available in the United Sates. The SGO is not supportive of any overt restriction of power morcellation. As surgical tools, power morcellators allow thousands of women the opportunity to have minimally invasive surgery (30).
The American Urogynecologic Society (AUGS) AUGS endorses the ACOG Special Report. AUGS also supports the FDA safety communication recommendation against the use of power morcellation for
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women with suspected or known uterine cancer. In cases of unsuspected malignancies (uterine sarcomas and carcinomas), dissemination from power morcellation may also reduce survival rates for these patients. When used correctly, in appropriately selected patients, power morcellation facilitates the completion of minimally invasive hysterectomy. Minimally invasive surgery is associated with reduction in postoperative morbidity, infection, pain and a quicker return to activities of daily living compared to open laparotomy. The decision to perform power morcellation during a supracervical hysterectomy for a minimally invasive mesh sacrocolpopexy should include a discussion between the physician and the patient of the risks and benefits during the informed consent process. AUGS supports the utilization of a registry to audit occult malignancy with hysterectomy for benign gynecologic conditions (31).
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All of these statements emphasize the importance of appropriate evaluation for uterine cancer and informed consent regarding the risk of tumor dissemination before proceeding with power morcellation. Morcellation and Leiomyosarcoma
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Power morcellation may disrupt and disseminate unrecognized uterine sarcoma into the peritoneal cavity, potentially worsening prognosis. There is currently insufficient evidence to conclude whether scalpel morcellation used for laparotomy, minilaparotomy, or vaginal
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procedures shares the same risk of dissemination of malignancy as power morcellation (14). Eliminating the use of power morcellation does not eliminate the risk of dissemination of
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malignant cells. As with any gynecologic malignancy, tumor extraction involves exposure of tissue to the peritoneal cavity and can lead to the spread of cancerous cells with the concern for upstaging of disease (32). The concern remains whether removal of the gynecologic malignancy is performed through open incision or laparoscopically. In a study of 56 patients with leiomyosarcoma, 25 patients were in the morcellation group and 31 patients in the nonmorcellation group (32). The results showed higher dissemination rates in the morcellation group, with 44% vs 12.9%, but only 1 of the 25 patients had power
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morcellation. The other 24 patients had hand morcellation with a scalpel via the vagina or through a mini-lap incision. The odds ratio for both recurrence and death were significantly
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worse for the morcellated group (32). Morcellation in a laparoscopic bag has been proposed to avoid tumor dissemination (1). Despite recent gains in popularity, the safety and efficacy of use of a laparoscopic bag to avoid
morcellation bag for intracorporal morcellation (1).
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Preoperative Evaluation
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tumor dissemination requires further study. At the current time there is no FDA approved
Pap smears and endometrial biopsy are inadequate for excluding leiomyosarcoma in women undergoing fibroid surgery. Ultrasound and MRI are being recommended but the reality is that neither can reliably diagnose nor exclude leiomyosarcoma. Ultrasound features suggestive
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of leiomyosarcoma include mixed echogenicity and central necrosis. Ultrasound color doppler findings include irregular vessel distribution, low impedance to flow, and high peak systolic velocity (33,34). In postmenopausal women presenting with bleeding, an endometrial echo > 4
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mm may indicate a pathological process and warrants further evaluation. (35). MRI findings
(36).
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suggestive of increased likelihood of malignancy include ill-defined margins and central necrosis
Although rapid growth of uterine leiomyomas may be suggestive of leiomyosarcoma, it
has not been shown to be a reliable predictor of leiomyosarcoma risk. One study of 1,332 women who underwent hysterectomy or myomectomy of presumed uterine leiomyomas found a 0.23% risk of sarcoma overall compared to 0.27% in those with rapid growth (9). Standard of Care in the Face of Changes in the FDA Warning and Litigation
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In legal terms, the standard of care refers to the level of care that a prudent physician with the same training and experience would administer under the same patient circumstances (37). Factors that help define the standard of care in a given clinical scenario include current medical
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literature, clinical practice guidelines from medical societies, manufacturer labeling, testimony of expert witnesses and FDA warnings. For a physician to be held liable, the patient’s attorney must prove a breach of standard care and a causal connection between the breach and the injury. If the
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essential element of breach of standard care cannot be proved, the physician should not be held liable (38). Labeling by the FDA is admissible to support a claim of negligence against the
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physician who fails to adhere to the labeling information. This is often referred to as the “Mulder rule” established by the Minnesota Supreme Court in Mulder v Parke Davis & Co. (39). The rule provides that when a manufacturer recommends the indications for a device, the precautionary measures that should be observed, and the potential dangers of its use, physician
(40).
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deviation from the recommendations can be admissible as evidence in a claim of negligence
When the FDA establishes a product warning that triggers a change in clinical practice, it
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may be perceived to be the new standard of care; especially when it leads to a change in labeling
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by manufacturers and change in practice guidelines by medical societies. Many gynecologists, understandably, will likely discontinue using a uterine power morcellation device in response to the recent FDA warning and revert back to performing laparotomy incisions for removal of uteri and fibroids. The FDA statement on November 24, 2014 specifically states, “Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision (2).” With the decline in
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use of power morcellation devices many patients will lose the benefits of smaller incisions and shorter recovery periods. Those who continue to use a uterine power morcellation device in the face of the recent FDA warning and litigation, risk reprimands from hospital credentialing
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committees and lawsuits. Documenting Informed Consent
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Minimally invasive gynecologists that continue to use power morcellation devices can reduce their risk of liability by not using power morcellation devices in peri- or post-menopausal
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women and in women suspected to have a uterine malignancy. With the new FDA warning, in those carefully selected younger patients in whom power morcellation is used documenting informed consent in the medical records is critical to lessen liability exposure. In a patient in whom power morcellation is to be used, the medical records should have documentation the
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patient has been informed of the risks of the procedure.
There are 2 standards to proper informed consent: that of the prudent physician and that of the reasonable patient. The standard, prudent physician vs reasonable patient varies by
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jurisdiction or state with the standard of prudent physician being accepted by the majority of states (37). The prudent physician standard examines whether the physician named in the suit
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operated in a manner that a prudent physician would in similar circumstances. Typically, expert witness testimony is required to determine what a prudent physician would disclose to a patient for a given surgical procedure. The reasonable patient standard states the physician needs to discuss the risks, benefits, indications, and alternatives that a reasonable patient would want to know (37). Regardless of whether the prudent physician or reasonable patient standard is used,
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documentation of a discussion of the new FDA warning against the use of morcellation devices will be an integral part of the informed consent process.
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Informed consent involves a thorough conversation between physician and patient about the risks and benefits of a specific procedure (14). Adequate informed consent often entails explaining the diagnosis, outlining the procedure, offering alternatives to the planned procedure,
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and providing the information that a prudent physician or a reasonable patient would want to know. Some states have specific laws defining informed consent. For example, in Kentucky
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informed consent is deemed to have been given
where a reasonable individual, from the information provided by the health care provider under the circumstances, would have a general understanding of the procedure and medically acceptable alternative procedures or treatments and substantial risks and hazards inherent in the proposed treatment or procedures (41).
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In this regard, physicians who choose to continue using power morcellators should discuss the alternatives, benefits, and substantial risks.
In line with AUGS recommendations, physicians should explain that power morcellators
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divide tissue into smaller pieces, allowing for a minimally invasive approach (31). Patients should be made aware of the benefits of a minimally invasive approach, including lower risk of
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infection, bleeding, venous thromboembolism, and abdominal wall hernias; less postoperative pain; shorter hospital stays; and quicker return to activities of daily living (31). Patients should understand the limitations of definitive preoperative methods of diagnosing leiomyosarcoma and the potential risk of intraperitoneal dissemination of malignant tissue, which may significantly worsen their prognosis. It is important that physicians clarify the FDA discourages the use of
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power morcellation during hysterectomy or myomectomy for fibroids because of the rare but potential risk of disseminating cancer cells and upstaging of disease (31).
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Physicians should adequately inform patients about alternative forms of morcellation during the informed consent discussion while clarifying that any form of morcellation regardless of the method will carry the rare, but potential, risk of dissemination of malignant cells.
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Similarly, alternatives to intraperitoneal morcellation should be discussed, including removal of tissue through a large incision. However, patients should be informed of the greater risks
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associated with open abdominal surgery, including wound complications, deep venous thrombosis, pulmonary embolism, extended hospitalization, and recovery (31). Patients should be aware that not all alternatives may be an option for every patient. An understanding of the decision to proceed with power morcellation is part of the shared decision-
medical record (31).
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making process, and the informed consent process should be fully documented in the patient’s
We offer the following language to supplement current surgical consent forms:
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I have been informed and understand that the FDA has issued a warning against the use of laparoscopic power morcellators because of the concern that power morcellation may spread cancerous cells. More specifically I have been informed of the following FDA statements pertaining to the use of laparoscopic power morcellators 1. Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroid(s) in patients who are peri- or post-menopausal. 2. Laparoscopic power morcellators are contraindicated in patients in whom the uterus and/or fibroid(s) can be removed intact through the vagina or small abdominal incision without the need for dissection of the tissue into smaller pieces. 3. Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
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4. That fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening prognosis (2).
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I have been informed and understand that my physician cannot guarantee my uterus and or fibroid(s) do not contain cancerous cells and the risk of uterine cancer such as leiomyosarcoma, in women undergoing uterine surgery for presumed benign uterine fibroids is estimated to range from 1 in 350 to 1 in 1,000.
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I have been informed of alternatives for removing my uterus and or fibroid(s) such as removal through the vagina or through an open abdominal incision.
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Conclusion
The November 24, 2014 FDA warning severely limits the use of laparoscopic power morcellators despite their benefits to the vast majority of patients who have undergone laparoscopic hysterectomy or myomectomy in the past. For many of these patients, a minimally invasive approach was made by possible by using a power morcellation device. Nevertheless, the
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FDA warning does have merit in that its intent is to try to reduce the risk of harm to those patients that are at risk of having uterine cancer that could spread by the use of a power morcellation device and decrease their survival. Also, the FDA statement does not totally
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exclude the use of laparoscopic power morcellators and explicitly keeps the door open for the
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use of laparoscopic power mocellators in “younger women who want to maintain their fertility or women not yet peri-menopausal who wish to keep their uterus after being informed of the risks.” It can be implied from the combination of the FDA statements that laparoscopic power morcellation is still an acceptable alternative in woman that are not peri- or post-menopausal and would need a large abdominal incision to remove their uterus and or fibroid(s). Intertwined with this is obtaining proper informed consent from the patient. ACOG, AAGL, AUGS, SGO, and SGS still support power morcellation as an effective therapeutic option when used in properly
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selected and informed patients. To reduce liability exposure, gynecologists who elect to continue to use morcellation devices should inform the patient of the risk of disseminating cancerous cells in the event of uterine malignancy. They should also document in the medical record the patient
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has been informed of the risks associated with power morcellation devices
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1. Power Morcellation and Occult Malignancy in Gynecologic Surgery. Executive
Summary. Washington, DC: American College of Obstetrics and Gynecology; 2014.
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2. UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm Issued November 24, 2014. Accessed December 20, 2014.
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3. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Issued
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April 17, 2014. Accessed July 2, 2014.
4. Kosary CL. SEER Survival Monograph: Cancer Survival Among Adults: U.S. SEER
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Program, 1988-2001, Patient and Tumor Characteristics. In: Ries LAG, Young JL, Keel GE, Eisner MP, Lin DY, Horner MD, editors. Cancer of the corpus uteri. Pub. No. 076215 ed. Bethesda, MD: National Cancer Institute, SEER Program, NIH; 2007. p. 123132.
5. American Cancer Society. Cancer Facts and Figures 2015. Atlanta, Ga: American Cancer Society; 2015.
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6. Brooks SE, Zhan M, Cote T, Baquet CR. Surveillance, epidemiology, and end results analysis of 2677 cases of uterine sarcoma 1989-1999. Gynecol Oncol. 2004; 93: 204-208. 7. D'Angelo E, Prat J, Uterine sarcomas: A review, Gynecol Oncol. 2009; 116(1): 131-139.
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8. Leibsohn S, d’Ablaing G, Mishell DR,Jr, Schlaerth JB. Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas. Am J Obstet Gynecol. 1990 Apr; 162(4): 968-74; discussion 974-6.
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9. Parker WH, Fu YS, Berek JS. Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma. Obstet Gynecol. 1994 Mar; 83(3): 414-418.
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10. Takamizawa S, Minakami H, Usui R, Noguchi S, Ohwada M, Suzuki M, et al. Risk of complications and uterine malignancies in women undergoing hysterectomy for presumed benign leiomyomas. Gynecol Obstet Invest. 1999; 48(3): 193-196. 11. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma
107.
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in black and white women: ultrasound evidence. Am J Obstet Gynecol 2003; 188: 100-
12. Robert L. Barbieri, Benefits and Pitfalls of open power morcellation of Uterine Fibroids.
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OBG Manag. 2014; 26(2): 10-15.
13. Wickerham DL, Fisher B, Wolmark N, et al. Association of tamoxifen and uterine
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sarcoma. J Clin Oncol 2002; 20:2758.
14. AAGL Special Article: Morcellation During Uterine Tissue Extraction. Journal of Minimally Invasive Gynecology. July/August 2014; 24:4.
15. Serrano C, Oduyebo T, Manola J, et al. Impact of tumor morcellation on the natural history of uterine leiomyosarcoma (ULMS), Paper 011, Session 4: Uterine
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Leiomyosarcomas, Final Program. Connective Tissue Oncology Society 18th Annual Meeting. 2013. New York, NY. 16. Kapp DS, Shin JY, Chan JK. Prognostic factors and survival in 1396 patients with uterine
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leiomyosarcomas: emphasis on impact of lymphadenectomy and oophorectomy. Cancer 2008; 112: 820–30.
17. Ray-Coquard I, Natukunda A, Blay JY, et al. Impact of chemotherapy in uterine sarcoma
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(UTS): review of 12 clinical trials from EORTC involving advanced UTS compared to other soft tissue sarcoma (STS). Paper 011, Session 4: Uterine Leiomyosarcomas, Final
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Program. Connective Tissue Oncology Society 18th Annual Meeting. 2013. New York, NY.
18. Dolinsky C. Endometrial Cancer: The Basics. OncoLink: Abramson Cancer Center of the University of Pennsylvania. 2008 Available:
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http://www.oncolink.org/types/article.cfm?c=6&s=18&ss=137&id=8227&CFID=920688 &CFTOKEN=55968454. Accessed September 22, 2014. 19. MAUDE - Manufacturer and User Facility Device Experience. FDA.
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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/textsearch.cfm. Updated June 18, 2014. Accessed December 20, 2014.
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20. Salem-Robinson v Richard Wolf Med. Instruments Corp., No. 5:14-cv-02209-PSG (N.D. Cal. 2014).
21. Burkhart v LiNA Med. U.S., No. 5:14-cv-01557-EGS (E.D. Pa. 2014). 22. Leuzzi v Ethicon Endo Surgery, Inc., No. 6:14-cv-06218 (W.D.N.Y. 2014). 23. Paduda v Karl Storz Endoscopy-Am., Inc., No. 14-cv-61086 (S.D. Fla. 2014). 24. Jane Hughes v. Dr. David Zisow, et al, No. 03C13004368 (MD Cir. 2014).
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25. Prior, CJ. Clearing Confusion about Perimenopause. BC Medical Journal. December 2005; 47(10): 538-542. 26. Perimenopausal Bleeding and Bleeding After Menopause. Washington, DC: American
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College of Obstetrics and Gynecology; May 2011.
http://www.acog.org/Patients/FAQs/Perimenopausal-Bleeding-and-Bleeding-After-
Issued May 2011. Accessed January 9, 2014.
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Menopause.
27. MEMBER UPDATE #5: AAGL Response to FDA Guidance on Use of Power
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Morcellation during Tissue Extraction for Uterine Fibroids
http://www.aagl.org/aaglnews/member-update-5-aagl-response-to-fda-guidance-on-useof-power-morcellation-during-tissue-extraction-for-uterine-fibroids/. Issued November 24, 2014. Accessed December 20, 2014.
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28. ACOG Statement on Power Morcellation. Washington, DC: American College of Obstetrics and Gynecology; November 2014. http://www.acog.org/About-ACOG/News-Room/Statements-and-
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Advisories/2014/ACOG-Statement-on-Power-Morcellation. Issued November 24, 2014. Accessed December 20, 2014.
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29. The Society of Gynecologic Surgeons: Special Report. http://www.sgsonline.org/assets/docs/Special_Reports/sgsacog%20support%20statement v2051214.pdf.
Issued May 12, 2014. Accessed September 21, 2014.
30. Statement of the Society of Gynecologic Oncology to the Food and Drug Administration’s Obstetrics and Gynecology Medical Devices Advisory Committee
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Concerning Safety of Laparoscopic Power Morcellation. http://www.sgo.org/newsroom/position-statements-2/morcellation/. Issued July10-11, 2014. Accessed September 21, 2014.
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31. AUGS Position Statement: Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy FDA Safety Communication and ACOG Special Report.
Issued May 14, 2014. Accessed October 3, 2014.
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http://www.augs.org/p/bl/et/blogid=16&blogaid=201
32. Park JY, Park SK, Kim DY, et al. The impact of tumor morcellation during surgery on
2011; 122: 225-259.
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the prognosis of patients with apparently early uterine leiomyosarcoma. Gynecol Oncol.
33. Amant F, Coosemans A, Debiec-Rychter M, Timmerman D, Vergote I. Clinical manganement of uterine sarcomas. Lancet Oncol. 2009; 10: 1188-1198.
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34. Russell DJ. The female pelvic mass. Diagnosis and management. Med Clin North Am 1995 Nov; 79(6): 1481-1493.
35. Goldstein SR. Significance of incidentally thick endometrial echo on transvaginal
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ultrasound in postmenopausal women. Menopause. 2011; 18: 434-436.
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36. Rha SE, Byun JY, Jung SE, Lee SL, Cho SM, Hwang SS, et al. CT and MRI of uterine sarcomas and their mimickers. AJR Am J Roentgenol. 2003 Nov; 181(5): 1369-1374.
37. Mucowski SJ, Jurnalov C, Phelps JY, et al. Use of vaginal mesh in the face of FDA warnings and litigation. Am J Obstet Gynecol 2010; 202.
38. Rosenbaum S. Medical errors, medical negligence, and professional medical liability reform. Public Health Rep. 2003; 118: 272-274. 39. Mulder v. Parke Davis & Company, 181 N.W.2d 882 (Minn. 1970).
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40. Vaslas B, Schreffler N. The Role of FDA-Approved Labeling in Medical Malpractice Litigation. Update. November/December 2010.
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41. Ky. Rev. Stat. Ann. § 304.40-320.
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Table 1: Anticipated New Cases in 2015 (5)
Cervical Cancer
12,900
Ovarian Cancer
21,290
Uterine Cancer
54,870
Uterine Sarcoma
1,097
Vaginal Cancer
4,070
Vulvar Cancer
5,150
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Table 1
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http://www.AAGL.org/jmig-22-4-JMIG-D-14-00417
S1553-4650(15)00081-3
DOI:
10.1016/j.jmig.2015.01.017
Reference:
JMIG 2477
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 19 August 2014 Revised Date:
20 January 2015
Accepted Date: 21 January 2015
Please cite this article as: Ton R, Kilic GS, Phelps JY, A Medical-Legal Review of Power Morcellation in the Face of the Recent FDA Warning and Litigation, The Journal of Minimally Invasive Gynecology (2015), doi: 10.1016/j.jmig.2015.01.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Article Type: Review Article Corresponding Author: Mrs. Raquel Ton, BS Corresponding Author's Institution: University of Texas Medical Branch at Galveston
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First Author: Raquel Ton, BS
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Order of Authors: Raquel Ton, BS; Gokhan S Kilic, MD; John Y Phelps, MD, JD, LLM
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Craig J. Sobolewski, MD, FACOG Division of Gynecologic Specialties Duke University Medical Center Box 3609 238 Baker House, Trent Drive (courier) Durham, NC 27710 Phone: (919) 681-5788 Fax: (919) 681-5929 Email: [email protected]
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Michael Sprague MD Cleveland Clinic Florida Section of Minimally Invasive Gynecology 2950 Cleveland Clinic Boulevard Weston, FL 33331 Phone: (954) 659-5559 Fax: (954) 659-5560 Email: [email protected]
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C.Y. Liu, MD Director, Women’s Surgery Center 1604 Gunbarrel Road Chattanooga Tennessee 37421 Phone: (423) 899-6511 Fax: (423) 899-1160 Email: [email protected]
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Suggested Reviewers
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A Medical-Legal Review of Power Morcellation in the Face of the Recent FDA Warning and Litigation
The University of Texas Medical Branch at Galveston The Department of Obstetrics & Gynecology
John Y. Phelps, MD, JD, LLM 301 University Blvd. Galveston, TX 77555-0587
Fax: (409) 747-5129
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Phone: (409) 772-8598
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Corresponding Author:
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The authors report no conflicts of interest
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Email: [email protected]
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Raquel Ton, BS; Gokhan S Kilic, MD; John Y Phelps, MD, JD, LLM
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Precis: A medical-legal review to help minimally invasive gynecologists who continue to perform uterine power morcellation despite the recent FDA warning and lawsuits.
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Short Title Medical-Legal Review of Liability Risks Associated with use of Uterine Power Morcellation Devices
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Abstract
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Minimally invasive gynecological surgeons who perform laparoscopic intraperitoneal morcellation should be aware of the recent US Food and Drug Administration (FDA) warning and litigation arising from use of morcellation devices with claims of intraperitoneal dissemination of cancerous cells. On November 24, 2014 the FDA issued a statement warning against using laparoscopic power morcellators in the majority of women undergoing
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hysterectomy or myomectomy for uterine fibroids. Despite best intentions in regards to their patients, gynecologists who continue to use power morcellation devices expose themselves to liability. This article is not meant to further deter gynecologists from using laparoscopic power
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morcellators, but to provide an interpretation of the FDA statement as to which patients the use
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of power morcellators may still be permitted under the FDA guidelines. This article also offers protective measures from a legal perspective for those who choose to continue to use power morcellators in the face of the recent FDA warning and litigation.
Keywords: liability, litigation, fibroids, morcellator, morcellation, FDA, boxed warning, leiomyosarcoma, consent
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Introduction Power morcellation has allowed previously ineligible women to undergo minimally
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invasive gynecologic surgery (1). Power morcellation devices have provided a method for removing large uteri and fibroids from the peritoneal cavity without the need of a laparotomy incision. Despite the known benefits of power morcellation devices for the vast majority of
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patients, on November 24, 2014 the FDA issued the following warning to health care providers.
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Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or minilaparotomy incision (2).
The FDA estimates that approximately 1 in 350 women who have a hysterectomy or myomectomy for fibroids have unsuspected uterine sarcoma, and the risk of morcellating an
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unsuspected uterine leiomyosarcoma is 1 in 498 (3). At our institution, in response to the FDA warning the University of Texas Medical Branch in Galveston has suspended use of power morcellators, but consideration is being given to allow power morcellation in select patients with
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proper informed consent. For our institution and other institutions struggling with the question of whether to continue uterine power morcellation, informed consent is a critical issue. The purpose
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of this medical-legal review is to help gynecologists who desire to continue to use a uterine power morcellation device by providing an interpretation of the FDA statement as to which patients the use of power morcellators may still be permitted under FDA guidelines. The purpose of this article is also to discuss the legal causes of action and the importance of documenting informed consent in the medical record. Breakdown and Interpretation of the FDA Statement
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The November 24, 2014 FDA statement explicitly states use of power morcellators is contraindicated in the following:
2.
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1. Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal. Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision.
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3. Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy (2).
The FDA statement explicitly does not exclude the use of power morcellators in all patients. In the last part of their statement entitled “Recommendations for Health Care Providers” the FDA narrowly opens the door for a use of power morcellation devices in select patients (2).
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The November 24, 2014 FDA statement provides the following:
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Thoroughly discuss the benefits and risks of all treatments with patients. Be certain to inform the small group of patients for whom laparoscopic power morcellation may be an acceptable therapeutic option that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis. This population might include some younger women who want to maintain their fertility or women not yet peri-menopausal who wish to keep their uterus after being informed of the risks (2). From the FDA statement it can be implied that the use laparoscopic power morcellators are still acceptable in patients that are not peri- or post-menopausal and would need a large abdominal incision to remove their uterus and or fibroid(s) (2).
Consistent with the provisions of the FDA statement: The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should
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be shared with patients when considering surgery with the use of these devices (2). A gynecologist that chooses to continue to use a laparoscopic power morcellators should
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inform their patients of the FDA warning that cancerous cells may spread cancer and decrease long term survival.
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Leiomyomas and uterine cancer
Uterine sarcoma accounts for only 7% to 8% of all uterine cancers (4). The incidence of
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uterine sarcoma is not nearly as prevalent as other types of gynecologic cancers, with only 1,600 new cases anticipated in 2014 compared to an anticipated 52,630 cases of uterine cancer (Table 1). Uterine leiomyosarcoma only accounts for 30% of the cases of uterine sarcoma and only 1.5% of all uterine cancers (6). Leiomyosarcoma is a rare, aggressive subtype of uterine cancer. In evaluating women with leiomyomas, determining which patients may have a leiomyosarcoma
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presents a significant challenge. There are no specific symptoms or preoperative diagnostic imaging that can reliably differentiate leiomyosarcoma from benign leiomyoma. The diagnosis of leiomyosarcoma is further complicated by the fact that the appearance of leiomyosarcomas
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can mimic that of benign leiomyomas (7). For women who undergo hysterectomy for presumed
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benign leiomyomas, the estimated risk of identifying leiomyosarcoma in the extracted specimen ranges from 1 in 350 to 1 in 1,000 (8–10). The risk factors for uterine sarcoma include black race, which carries a 2 -fold higher incidence of leiomyosarcoma (11); advancing age, with a mean diagnosis age of 60 years (12); prolonged tamoxifen use ≥ 5 years (13); pelvic radiation, hereditary leiomyomatosis, and renal cell cancer (HLRCC); and childhood retinoblastoma (7). Patients can present with abnormal vaginal bleeding (56%), palpable pelvic mass (54%), and pelvic pain (22%) (7).
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The overall survival with leiomyosarcoma is poor (14). While treatment for leiomyosarcoma is largely hysterectomy and bilateral salpingo-oophorectomy, there are ongoing trials to determine the optimal treatment (7). Current comprehensive studies are underway to
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determine the impact of morcellation in patients with early stage leiomyosarcoma, compared to resection by total abdominal hysterectomy. In one study of 68 patients with surgically resectable leiomyosarcoma from 2007 to 2012, a 100% peritoneal recurrence was found in the morcellated
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group (16 patients) vs 38% in the total abdominal hysterectomy group (52 patients) (15). The authors in this study determined that morcellation as a first surgery after diagnosis decreased
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time to recurrence of leiomyosarcoma. However, the median survival of 5 years was the same in both surgical approaches (15). Leiomyosarcoma carries a 5 year survival of only 66% regardless of the stage (16). More studies are needed to determine a reliably effective adjuvant treatment for leiomyosarcoma. Due to the aggressive nature of the disease, neither radiation nor chemotherapy
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has had a significant impact on survival. In one study, a group of 225 patients diagnosed with uterine sarcoma, with no prior chemotherapy, were treated with combinations of chemotherapeutic agents as first line treatment. No significant effect on overall survival was
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observed, and leiomyosarcoma had a lower response than other types of uterine sarcoma (20% vs 33%). The authors determined that leiomyosarcoma has a poor survival rate even when treated
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with chemotherapy, and new treatment methods are needed to improve this response (17). Unlike leiomyosarcomas, endometrial cancer is easier to diagnose. Most cases present
with abnormal bleeding and can usually be diagnosed by simple endometrial biopsy (14). The incidence of endometrial cancer is higher than that of leiomyosarcomas, and while leiomyosarcomas account for 1.5% of all uterine cancers, endometrial cancer accounts for 75%–80% of all uterine cancers (6,18). The risk of endometrial cancer increases with age,
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obesity, and unopposed estrogen. The peak incidence is between 75 and 90 years, with a mean age of 66 years (14).
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Adverse Event Reports in the Manufacturer and User Facility Device Experience (MAUDE) Database
The Manufacturer and User Facility Device Experience (MAUDE) is a database for
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medical device reports submitted to the FDA by mandatory and voluntary reporters. A recent search of the database using the key words “morcellator” “morcellation” “leiomyosarcoma,” and
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“cancer” returned 31 adverse event reports, with actual event occurrences dating back to 2006 (19). One report examined the death of the reporter’s sister in 2013 following a supracervical laparoscopic hysterectomy for uterine fibroids assisted by use of a uterine power morcellator in March 2012 (19). Post operatively, it was discovered that she had uterine leiomyosarcoma. She
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underwent a second surgery 6 weeks later to remove her cervix and chemotherapy shortly thereafter. The report further claims that prior to surgery she was never informed of the possibility of uterine cancer that she might have cancer or that her uterus would be morcellated
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(19).
One report filed against Johnson and Johnson Services Inc. examined the death of a
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reporter’s wife following a vaginal hysterectomy in November 2009. According to the report, the patient had post-menopausal bleeding and a rapidly enlarging uterus, “suspicious for leiomyosarcoma (19).” The patient was referred to a gynecological oncologist who stated that the she did not “fit the profile” for uterine cancer and that “the possibility of cancer was small (19).” He recommended a laparoscopic-assisted vaginal hysterectomy with morcellation. The report states that neither verbal nor written informed consent mentioned the possibility of the spread of
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cancer cells. Following surgery, the patient presented with intestinal blockage, and new metastatic leiomyosarcoma was discovered. The manufacturer Johnson and Johnson Services Inc. was not notified of the complaint at the time, but in a later report they provided the
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following response:
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The device information for use under precautions states, caution: the use of a laparoscopic tissue extraction bag is recommended for the morcellation of malignant tissue or tissue suspected of being malignant and for tissue that the physician considers to be potentially harmful when disseminated in a body cavity. As morcellation may affect endometrial pathologic examination, preoperative evaluation of the endometrium should be considered. Should malignancy be identified, use of the gynecare morcellex tissue morcellator may lead to dissemination of malignant tissue (19).
Johnson and Johnson Services Inc. stated that safety precautions, outlining the possibility of disseminating both benign and malignant tissue, were listed on the morcellator devices (19).
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Examples of Litigation against Morcellator Manufacturers
A number of product liability suits have been filed against manufacturers of uterine power morcellation devices. In the case Salem-Robinson v Richard Wolf Med. Instruments Corp.,
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Sarah Salem-Robinson had a supracervical hysterectomy in which a morcellation device manufactured by Wolf Corporation was used (20). Prior to the patient’s surgery, there was no
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evidence of disseminated or metastatic cancer. Following the procedure, the patient was informed that one of the fibroids was a leiomyosarcoma and not a benign fibroid as previously thought. The patient was then informed that because a morcellator device was used during her surgery, there was significant risk that cancer cells had disseminated within her peritoneal cavity. Initial imaging of her lungs, abdomen, and pelvis showed no evidence of cancer. However, the patient subsequently developed 4 lesions in one of her lungs that potentially represented
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metastatic leiomyosarcoma. It is alleged that Wolf Corporation failed to warn about the possibility of dissemination of an occult uterine leiomyosarcoma throughout the peritoneal cavity and that they were aware of the risks, complications, and adverse events associated with their
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products used for uterine morcellation (20). More patients followed suit, filing similar product liability cases including Burkhart v LiNA Med. U.S. (21), Leuzzi v Ethicon Endo Surgery, Inc
verdicts.
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Example of Litigation against a Gynecologist
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(22), and Paduda v Karl Storz Endoscopy-Am., Inc (23). These cases have not yet rendered
In the case Jane Hughes v Dr. David Zisow, et al, Jane Hughes filed a lawsuit against practicing gynecologist Dr. David Zisow and Zisow Surgical, LLC claiming medical negligence (24). Jane Hughes consulted Dr. Zisow for uterine fibroids causing heavy menstrual bleeding.
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The lawsuit alleges that he recommended a hysterectomy and cholecystectomy in a combined laparoscopic procedure. According to the lawsuit, Dr. Zisow allegedly told Jane Hughes that she had a grossly enlarged, friable, 30-week-sized uterus. In 2010 Dr. Zisow performed a
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laparoscopic hysterectomy with power morcellation, and the pathology report allegedly made no mention of cancer. Two years later the patient represented with a 20 centimeter pelvic mass.
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According to the lawsuit, Dr. Zisow allegedly told the patient that the morcellator may have caused seeding of cancer and advised another surgery. The subsequent pathology report allegedly noted stage 4 leiomyosarcoma. Jane Hughes then filed suit claiming that Dr. Zisow “negligently used a morcellator suprapubically to morcellate the large uterus and remove it from the abdominal cavity,” disseminating a leiomyosarcoma. The lawsuit stated the surgery should have been completed
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without the use of a morcellator. Jane Hughes, in her lawsuit, claimed that under these circumstances, Dr. Zisow was in violation of acceptable standard of care. Based on his description of the fibroid as “large” and “friable,” it is alleged that Dr. Zisow knew he could
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have been morcellating a leiomyosarcoma (24). The lawsuit stated that standard of care requires that gynecologists not morcellate any tissue suspicious of leioymosarcoma. The lawsuit claims Dr. Zisow stated that all the fibroid tissue that could be removed was removed, but identification
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of all the tissue was difficult and some was left behind. The lawsuit also alleges that the degree of tissue destruction by morcellation made it difficult for the pathologist to make a diagnosis of
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leiomyosarcoma. According to the lawsuit, in order for Dr. Zisow to conform to acceptable standards of care, he should have removed the uterus intact so that proper pathologic identification could be made. The lawsuit further stated that if Dr. Zisow had done so, then “with reasonable medical probability, a diagnosis of leiomyosarcoma could have been made when the
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patient was in stage 1 with a 5 year survival of at least 58% (24).” Jane Hughes claims that she was never informed of the possibility of sarcoma or the possibility of seeding from the morcellator (24). This case settled prior to trial, without a finding of fault on the part of Dr.
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Zisow. Once the lawsuit was filed, the case information became available to the public.
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The new FDA, November 24, 2014, warning includes a contraindication for both perimenopausal and post-menopausal women. However, it does not adequately define perimenopause, and the peri-menopausal stage can be difficult to determine. Peri-menopause is a gray area manifested by irregular cycles, hot flashes, mood swings (25). The American College of Obstetricians and Gynecologists (ACOG) defines menopause as the absence of menstrual periods for 12 months and peri-menopause as the months or years leading up to this point and peri-menopause can last for up to 10 years (26). The FDA statement that power morcellation is
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contraindicated in peri-menopausal women does not identify a clear point in time in a woman’s life in which power morcellation may or may not be permitted.
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Review of Medical Association Statements Pertaining to Morcellation American Association of Gynecologic Laparoscopists (AAGL)
The AAGL released the following updated statement in response to the FDA guidance regarding
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power morcellation:
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The AAGL supports the FDA’s recommendation for a boxed warning to provide enhanced informed consent, however, we are concerned with the summarization of contraindications in all peri- and post-menopausal women and we agree with the American College of Obstetrics and Gynecologists that additional clarification “regarding certain language within the contraindication that could be confusing to patients and physicians” is needed. Specifically, the following information needs to be clarified: a specific definition of peri-menopausal women; the role of power morcellation in the large group of reproductive-aged women who undergo myomectomy for fertility-sparing surgery; use of power morcellation in patients with non-fibroid uteri who may have refractory uterine bleeding, prolapse or adenomyosis; guidance regarding the use of containment bags; and guidance regarding the role of non-power morcellation (use of a manual cold knife scalpel in vaginal or mini-laparotomy tissue extraction). In summary, abandoning power morcellation technology for many patients undergoing minimally invasive myomectomy, supracervical hysterectomy, or hysterectomy for a large uterus will be a setback in the care of patients with gynecologic conditions. With meticulous adherence to preoperative patient selection guidelines and informed consent, the AAGL believes appropriately performed power morcellation outweighs the risk of laparotomy in low-risk patients and is an option to be carefully considered by patients and their gynecologists (27).
American College of Obstetricians and Gynecologists (ACOG) As we have said in the past, we continue to believe that power morcellation has a role in gynecologic surgery. Power morcellation can make it possible for some women to undergo less-invasive laparoscopic hysterectomy or myomectomy, sparing them the longer recovery time and higher mortality rates associated with a total abdominal procedure. The FDA’s clarification of contraindications for morcellation will help to ensure that only women at low risk for an occult malignancy will undergo laparoscopic hysterectomy or myomectomy with morcellation. However, we look forward to working with the FDA to provide
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additional clarification regarding certain language within the contraindications that could be confusing to patients and physicians. Although the worsening of an occult malignancy as a result of power morcellation is, of course, tragic, we believe that an approach that combines deliberate patient selection criteria with robust informed consent will help protect women from a negative outcome, while maintaining access to morcellation for women who would benefit from it (28). Society of Gynecologic Surgeons (SGS)
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The society strongly advocates that gynecologic surgeons communicate clearly with patients regarding the available approaches to hysterectomy, including the risks and benefits for each technique based upon current scientific evidence. The society further advocates that surgeons maintain vigilance with regard to safety when choosing a minimally invasive approach, such as vaginal or laparoscopic hysterectomy. The SGS supports and endorses the special report of the American College of Obstetricians and Gynecologists regarding the use of power morcellation and their conclusion that the available evidence and potential benefits of morcellation do not warrant a complete ban of this technique. The society also supports the report of the AAGL task force concerning safe and efficient tissue extraction during hysterectomy (29). The Society of Gynecologic Oncology (SGO)
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To date there is insufficient prospective data to prove that morcellation results in a decrease in progression free and overall survival. Finally, as gynecologic oncologists we know that even when uterine sarcomas are removed intact there is still a very poor prognosis with these aggressive malignancies. Any assessment must recognize that the overwhelming majority of hysterectomies and myomectomies done in the U.S. are done for benign fibroids. In these circumstances intracorporeal morcellation has benefited hundreds of thousands of women. It is especially beneficial for the two-thirds of American women who are obese, and in whom laparotomy increases both morbidity and mortality. It would be a disservice to deny these or any women this surgical option. As physicians we know we must strive to never harm any one of our patients. But banning morcellation may cause more harm to more women. Thus, the Society of Gynecologic Oncology’s position is that power morcellation with appropriate informed consent should remain available in the United Sates. The SGO is not supportive of any overt restriction of power morcellation. As surgical tools, power morcellators allow thousands of women the opportunity to have minimally invasive surgery (30).
The American Urogynecologic Society (AUGS) AUGS endorses the ACOG Special Report. AUGS also supports the FDA safety communication recommendation against the use of power morcellation for
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women with suspected or known uterine cancer. In cases of unsuspected malignancies (uterine sarcomas and carcinomas), dissemination from power morcellation may also reduce survival rates for these patients. When used correctly, in appropriately selected patients, power morcellation facilitates the completion of minimally invasive hysterectomy. Minimally invasive surgery is associated with reduction in postoperative morbidity, infection, pain and a quicker return to activities of daily living compared to open laparotomy. The decision to perform power morcellation during a supracervical hysterectomy for a minimally invasive mesh sacrocolpopexy should include a discussion between the physician and the patient of the risks and benefits during the informed consent process. AUGS supports the utilization of a registry to audit occult malignancy with hysterectomy for benign gynecologic conditions (31).
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All of these statements emphasize the importance of appropriate evaluation for uterine cancer and informed consent regarding the risk of tumor dissemination before proceeding with power morcellation. Morcellation and Leiomyosarcoma
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Power morcellation may disrupt and disseminate unrecognized uterine sarcoma into the peritoneal cavity, potentially worsening prognosis. There is currently insufficient evidence to conclude whether scalpel morcellation used for laparotomy, minilaparotomy, or vaginal
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procedures shares the same risk of dissemination of malignancy as power morcellation (14). Eliminating the use of power morcellation does not eliminate the risk of dissemination of
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malignant cells. As with any gynecologic malignancy, tumor extraction involves exposure of tissue to the peritoneal cavity and can lead to the spread of cancerous cells with the concern for upstaging of disease (32). The concern remains whether removal of the gynecologic malignancy is performed through open incision or laparoscopically. In a study of 56 patients with leiomyosarcoma, 25 patients were in the morcellation group and 31 patients in the nonmorcellation group (32). The results showed higher dissemination rates in the morcellation group, with 44% vs 12.9%, but only 1 of the 25 patients had power
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morcellation. The other 24 patients had hand morcellation with a scalpel via the vagina or through a mini-lap incision. The odds ratio for both recurrence and death were significantly
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worse for the morcellated group (32). Morcellation in a laparoscopic bag has been proposed to avoid tumor dissemination (1). Despite recent gains in popularity, the safety and efficacy of use of a laparoscopic bag to avoid
morcellation bag for intracorporal morcellation (1).
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Preoperative Evaluation
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tumor dissemination requires further study. At the current time there is no FDA approved
Pap smears and endometrial biopsy are inadequate for excluding leiomyosarcoma in women undergoing fibroid surgery. Ultrasound and MRI are being recommended but the reality is that neither can reliably diagnose nor exclude leiomyosarcoma. Ultrasound features suggestive
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of leiomyosarcoma include mixed echogenicity and central necrosis. Ultrasound color doppler findings include irregular vessel distribution, low impedance to flow, and high peak systolic velocity (33,34). In postmenopausal women presenting with bleeding, an endometrial echo > 4
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mm may indicate a pathological process and warrants further evaluation. (35). MRI findings
(36).
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suggestive of increased likelihood of malignancy include ill-defined margins and central necrosis
Although rapid growth of uterine leiomyomas may be suggestive of leiomyosarcoma, it
has not been shown to be a reliable predictor of leiomyosarcoma risk. One study of 1,332 women who underwent hysterectomy or myomectomy of presumed uterine leiomyomas found a 0.23% risk of sarcoma overall compared to 0.27% in those with rapid growth (9). Standard of Care in the Face of Changes in the FDA Warning and Litigation
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In legal terms, the standard of care refers to the level of care that a prudent physician with the same training and experience would administer under the same patient circumstances (37). Factors that help define the standard of care in a given clinical scenario include current medical
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literature, clinical practice guidelines from medical societies, manufacturer labeling, testimony of expert witnesses and FDA warnings. For a physician to be held liable, the patient’s attorney must prove a breach of standard care and a causal connection between the breach and the injury. If the
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essential element of breach of standard care cannot be proved, the physician should not be held liable (38). Labeling by the FDA is admissible to support a claim of negligence against the
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physician who fails to adhere to the labeling information. This is often referred to as the “Mulder rule” established by the Minnesota Supreme Court in Mulder v Parke Davis & Co. (39). The rule provides that when a manufacturer recommends the indications for a device, the precautionary measures that should be observed, and the potential dangers of its use, physician
(40).
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deviation from the recommendations can be admissible as evidence in a claim of negligence
When the FDA establishes a product warning that triggers a change in clinical practice, it
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may be perceived to be the new standard of care; especially when it leads to a change in labeling
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by manufacturers and change in practice guidelines by medical societies. Many gynecologists, understandably, will likely discontinue using a uterine power morcellation device in response to the recent FDA warning and revert back to performing laparotomy incisions for removal of uteri and fibroids. The FDA statement on November 24, 2014 specifically states, “Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision (2).” With the decline in
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use of power morcellation devices many patients will lose the benefits of smaller incisions and shorter recovery periods. Those who continue to use a uterine power morcellation device in the face of the recent FDA warning and litigation, risk reprimands from hospital credentialing
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committees and lawsuits. Documenting Informed Consent
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Minimally invasive gynecologists that continue to use power morcellation devices can reduce their risk of liability by not using power morcellation devices in peri- or post-menopausal
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women and in women suspected to have a uterine malignancy. With the new FDA warning, in those carefully selected younger patients in whom power morcellation is used documenting informed consent in the medical records is critical to lessen liability exposure. In a patient in whom power morcellation is to be used, the medical records should have documentation the
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patient has been informed of the risks of the procedure.
There are 2 standards to proper informed consent: that of the prudent physician and that of the reasonable patient. The standard, prudent physician vs reasonable patient varies by
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jurisdiction or state with the standard of prudent physician being accepted by the majority of states (37). The prudent physician standard examines whether the physician named in the suit
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operated in a manner that a prudent physician would in similar circumstances. Typically, expert witness testimony is required to determine what a prudent physician would disclose to a patient for a given surgical procedure. The reasonable patient standard states the physician needs to discuss the risks, benefits, indications, and alternatives that a reasonable patient would want to know (37). Regardless of whether the prudent physician or reasonable patient standard is used,
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documentation of a discussion of the new FDA warning against the use of morcellation devices will be an integral part of the informed consent process.
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Informed consent involves a thorough conversation between physician and patient about the risks and benefits of a specific procedure (14). Adequate informed consent often entails explaining the diagnosis, outlining the procedure, offering alternatives to the planned procedure,
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and providing the information that a prudent physician or a reasonable patient would want to know. Some states have specific laws defining informed consent. For example, in Kentucky
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informed consent is deemed to have been given
where a reasonable individual, from the information provided by the health care provider under the circumstances, would have a general understanding of the procedure and medically acceptable alternative procedures or treatments and substantial risks and hazards inherent in the proposed treatment or procedures (41).
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In this regard, physicians who choose to continue using power morcellators should discuss the alternatives, benefits, and substantial risks.
In line with AUGS recommendations, physicians should explain that power morcellators
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divide tissue into smaller pieces, allowing for a minimally invasive approach (31). Patients should be made aware of the benefits of a minimally invasive approach, including lower risk of
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infection, bleeding, venous thromboembolism, and abdominal wall hernias; less postoperative pain; shorter hospital stays; and quicker return to activities of daily living (31). Patients should understand the limitations of definitive preoperative methods of diagnosing leiomyosarcoma and the potential risk of intraperitoneal dissemination of malignant tissue, which may significantly worsen their prognosis. It is important that physicians clarify the FDA discourages the use of
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power morcellation during hysterectomy or myomectomy for fibroids because of the rare but potential risk of disseminating cancer cells and upstaging of disease (31).
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Physicians should adequately inform patients about alternative forms of morcellation during the informed consent discussion while clarifying that any form of morcellation regardless of the method will carry the rare, but potential, risk of dissemination of malignant cells.
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Similarly, alternatives to intraperitoneal morcellation should be discussed, including removal of tissue through a large incision. However, patients should be informed of the greater risks
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associated with open abdominal surgery, including wound complications, deep venous thrombosis, pulmonary embolism, extended hospitalization, and recovery (31). Patients should be aware that not all alternatives may be an option for every patient. An understanding of the decision to proceed with power morcellation is part of the shared decision-
medical record (31).
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making process, and the informed consent process should be fully documented in the patient’s
We offer the following language to supplement current surgical consent forms:
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I have been informed and understand that the FDA has issued a warning against the use of laparoscopic power morcellators because of the concern that power morcellation may spread cancerous cells. More specifically I have been informed of the following FDA statements pertaining to the use of laparoscopic power morcellators 1. Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroid(s) in patients who are peri- or post-menopausal. 2. Laparoscopic power morcellators are contraindicated in patients in whom the uterus and/or fibroid(s) can be removed intact through the vagina or small abdominal incision without the need for dissection of the tissue into smaller pieces. 3. Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
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4. That fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening prognosis (2).
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I have been informed and understand that my physician cannot guarantee my uterus and or fibroid(s) do not contain cancerous cells and the risk of uterine cancer such as leiomyosarcoma, in women undergoing uterine surgery for presumed benign uterine fibroids is estimated to range from 1 in 350 to 1 in 1,000.
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I have been informed of alternatives for removing my uterus and or fibroid(s) such as removal through the vagina or through an open abdominal incision.
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Conclusion
The November 24, 2014 FDA warning severely limits the use of laparoscopic power morcellators despite their benefits to the vast majority of patients who have undergone laparoscopic hysterectomy or myomectomy in the past. For many of these patients, a minimally invasive approach was made by possible by using a power morcellation device. Nevertheless, the
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FDA warning does have merit in that its intent is to try to reduce the risk of harm to those patients that are at risk of having uterine cancer that could spread by the use of a power morcellation device and decrease their survival. Also, the FDA statement does not totally
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exclude the use of laparoscopic power morcellators and explicitly keeps the door open for the
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use of laparoscopic power mocellators in “younger women who want to maintain their fertility or women not yet peri-menopausal who wish to keep their uterus after being informed of the risks.” It can be implied from the combination of the FDA statements that laparoscopic power morcellation is still an acceptable alternative in woman that are not peri- or post-menopausal and would need a large abdominal incision to remove their uterus and or fibroid(s). Intertwined with this is obtaining proper informed consent from the patient. ACOG, AAGL, AUGS, SGO, and SGS still support power morcellation as an effective therapeutic option when used in properly
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selected and informed patients. To reduce liability exposure, gynecologists who elect to continue to use morcellation devices should inform the patient of the risk of disseminating cancerous cells in the event of uterine malignancy. They should also document in the medical record the patient
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has been informed of the risks associated with power morcellation devices
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1. Power Morcellation and Occult Malignancy in Gynecologic Surgery. Executive
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2. UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication
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3. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication.
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6. Brooks SE, Zhan M, Cote T, Baquet CR. Surveillance, epidemiology, and end results analysis of 2677 cases of uterine sarcoma 1989-1999. Gynecol Oncol. 2004; 93: 204-208. 7. D'Angelo E, Prat J, Uterine sarcomas: A review, Gynecol Oncol. 2009; 116(1): 131-139.
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10. Takamizawa S, Minakami H, Usui R, Noguchi S, Ohwada M, Suzuki M, et al. Risk of complications and uterine malignancies in women undergoing hysterectomy for presumed benign leiomyomas. Gynecol Obstet Invest. 1999; 48(3): 193-196. 11. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma
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15. Serrano C, Oduyebo T, Manola J, et al. Impact of tumor morcellation on the natural history of uterine leiomyosarcoma (ULMS), Paper 011, Session 4: Uterine
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Leiomyosarcomas, Final Program. Connective Tissue Oncology Society 18th Annual Meeting. 2013. New York, NY. 16. Kapp DS, Shin JY, Chan JK. Prognostic factors and survival in 1396 patients with uterine
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leiomyosarcomas: emphasis on impact of lymphadenectomy and oophorectomy. Cancer 2008; 112: 820–30.
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(UTS): review of 12 clinical trials from EORTC involving advanced UTS compared to other soft tissue sarcoma (STS). Paper 011, Session 4: Uterine Leiomyosarcomas, Final
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Program. Connective Tissue Oncology Society 18th Annual Meeting. 2013. New York, NY.
18. Dolinsky C. Endometrial Cancer: The Basics. OncoLink: Abramson Cancer Center of the University of Pennsylvania. 2008 Available:
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http://www.oncolink.org/types/article.cfm?c=6&s=18&ss=137&id=8227&CFID=920688 &CFTOKEN=55968454. Accessed September 22, 2014. 19. MAUDE - Manufacturer and User Facility Device Experience. FDA.
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Morcellation during Tissue Extraction for Uterine Fibroids
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Concerning Safety of Laparoscopic Power Morcellation. http://www.sgo.org/newsroom/position-statements-2/morcellation/. Issued July10-11, 2014. Accessed September 21, 2014.
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31. AUGS Position Statement: Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy FDA Safety Communication and ACOG Special Report.
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http://www.augs.org/p/bl/et/blogid=16&blogaid=201
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37. Mucowski SJ, Jurnalov C, Phelps JY, et al. Use of vaginal mesh in the face of FDA warnings and litigation. Am J Obstet Gynecol 2010; 202.
38. Rosenbaum S. Medical errors, medical negligence, and professional medical liability reform. Public Health Rep. 2003; 118: 272-274. 39. Mulder v. Parke Davis & Company, 181 N.W.2d 882 (Minn. 1970).
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40. Vaslas B, Schreffler N. The Role of FDA-Approved Labeling in Medical Malpractice Litigation. Update. November/December 2010.
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Table 1: Anticipated New Cases in 2015 (5)
Cervical Cancer
12,900
Ovarian Cancer
21,290
Uterine Cancer
54,870
Uterine Sarcoma
1,097
Vaginal Cancer
4,070
Vulvar Cancer
5,150
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Table 1
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http://www.AAGL.org/jmig-22-4-JMIG-D-14-00417
