Gordon et al.
28 Tsuda E, Kawamata K, Neki R, Echigo S, Chiba Y. Nationwide survey of pregnancy and delivery in patients with coronary arterial lesions caused by Kawasaki disease in Japan. Cardiol Young 2006;16:173– 8. 29 Tsuda E, Ishihara Y, Kawamata K, Tsukano S, Negi R, Echigo S, et al. Pregnancy and delivery in patients with coronary artery lesions caused by Kawasaki disease. Heart (Br Card Soc) 2005;91:1481–2. 30 Tatsumi T. Four cases of pregnancies in women with a history of Kawasaki disease and coronary artery aneurysms. Nippon Shoni Junkanki Gakkai 2001;17:52–9. 31 Nolan TE, Savage RW. Peripartum myocardial infarction from presumed Kawasaki’s disease. South Med J 1990;83:1360–1. 32 Shear R, Leduc L. Successful pregnancy following Kawasaki disease. Obstet Gynecol 1999;94:841.
33 Hibbard JU, Fajardo JE, Briller J. Kawasaki disease with coronary artery sequelae. Obstet Gynecol 2007;109:517–19. 34 McAndrew P, Hughes D, Adams P. Pregnancy and Kawasaki disease. Int J Obstet Anesth 2000;9:279–81. 35 Hata A, Onouchi Y. Susceptibility genes for Kawasaki disease: toward implementation of personalized medicine. J Hum Genet 2009;54:67–73. 36 Onouchi Y. Molecular genetics of Kawasaki disease. Pediatr Res 2009;65:46R–54R. 37 Uehara R, Yashiro M, Nakamura Y, Yanagawa H. Kawasaki disease in parents and children. Acta Paediatr 2003;92:694–7. 38 Dergun M, Kao A, Hauger SB, Newburger JW, Burns JC. Familial occurrence of Kawasaki syndrome in North America. Arch Pediatr Adolesc Med 2005;159:876–81.
The rise and fall of the vaginal mesh SWATI JHA, CONSULTANT (O&G) AND HONORARY SENIOR CLINICAL LECTURER, SUBSPECIALIST IN UROGYNAECOLOGY, UK
..................................................................................................................................................................... Recent high profile cases involving use of vaginal meshes for treating pelvic organ prolapse (POP) and stress urinary incontinence include Christine Scott v. Kannappan ($5.5 million payout in July 2012) and Linda Gross v. Ethicon ($11.1 million payout in March 2013). Vaginal mesh manufacturers currently facing consolidated cases in US federal courts include Bard, Ethicon, Cook Medical, Coloplast, Boston Scientific Corp. and American Medical Systems. Several are allegedly considering settlements of several million pounds to compensate complications, loss of earnings and medical expenses. The use of vaginal meshes increased exponentially after their introduction into routine clinical practice in 2005, following only minimal testing based on the US FDA (Food and Drug Administration) 501 clearance method (a product predicated on an existing and approved device can forego the usually rigorous process of approval). Thus, the devices were introduced with minimal clinical safety trials. Vaginal meshes were believed to prevent recurrent prolapse, avoiding the one in three risk of needing further surgery over a lifetime following traditional primary prolapse surgery. Following rising reports of complications, in January 2012 the FDA ordered vaginal mesh manufacturers to perform postmarket surveillance studies (522 studies) to address safety and
1438
effectiveness concerns. Following this, Bard and Ethicon withdrew their vaginal prolapse meshes from the market; however, several other companies have commenced these studies in an unprecedented collaboration between industry, FDA and the American Urogynecologic Society and are striving to create a national prolapse surgery registry (Pelvic Floor Disorders Registry, PFDR). The ACOG, AUG, RANZGOG and in the UK, NICE (IP 267, 280-284), MHRA (Medicines and Healthcare Products Regulatory Agency), BSUG, BAUS and the Department of Health have now all issued guidance on the use of transvaginal meshes for POP, which is very similar. Neither the FDA nor the MHRA have declared an inherent problem with the device or with a single brand. The emphasis is on adequately trained clinicians performing these procedures, appropriate patient selection, discussion at an MDT, and informed consent from patients after reviewing the risks and benefits of the procedure as well as audit and monitoring of long-term outcomes on a recognised surgical database. Adverse events should be reported to a regulatory body. Standardised consent forms and patient information leaflets (available from the specialist societies) should be used. Surgery for removal of these meshes
where indicated should be undertaken in recognised specialist centres. Vaginal mesh POP repair introduces risks not present in traditional surgery. The Cochrane review on the use of synthetic mesh demonstrates that although effectiveness does not seem to be increased by the use of apical/ posterior vaginal wall mesh, use of the anterior and multiple compartments may offer some anatomical benefit. However, this may not equate to better symptomatic results and also brings to question whether the added risk is worth the additional benefit? The other issue is the ethics of depriving suitable patients this procedure due to clinician anxiety. These events should serve as a warning to early adopters and clinicians need to be prepared for greater scrutiny of their practice by the legal profession.
Disclosure of interests and funding SJ has received funding from Ethicon to conduct the UK National Prolapse Survey performed in 2004 and subsequently repeated in 2009. She is also on the Advisory board for Astellas. Contribution to authorship Conceived the article, did the literature search and wrote the article. &
ª 2014 Royal College of Obstetricians and Gynaecologists
28 Tsuda E, Kawamata K, Neki R, Echigo S, Chiba Y. Nationwide survey of pregnancy and delivery in patients with coronary arterial lesions caused by Kawasaki disease in Japan. Cardiol Young 2006;16:173– 8. 29 Tsuda E, Ishihara Y, Kawamata K, Tsukano S, Negi R, Echigo S, et al. Pregnancy and delivery in patients with coronary artery lesions caused by Kawasaki disease. Heart (Br Card Soc) 2005;91:1481–2. 30 Tatsumi T. Four cases of pregnancies in women with a history of Kawasaki disease and coronary artery aneurysms. Nippon Shoni Junkanki Gakkai 2001;17:52–9. 31 Nolan TE, Savage RW. Peripartum myocardial infarction from presumed Kawasaki’s disease. South Med J 1990;83:1360–1. 32 Shear R, Leduc L. Successful pregnancy following Kawasaki disease. Obstet Gynecol 1999;94:841.
33 Hibbard JU, Fajardo JE, Briller J. Kawasaki disease with coronary artery sequelae. Obstet Gynecol 2007;109:517–19. 34 McAndrew P, Hughes D, Adams P. Pregnancy and Kawasaki disease. Int J Obstet Anesth 2000;9:279–81. 35 Hata A, Onouchi Y. Susceptibility genes for Kawasaki disease: toward implementation of personalized medicine. J Hum Genet 2009;54:67–73. 36 Onouchi Y. Molecular genetics of Kawasaki disease. Pediatr Res 2009;65:46R–54R. 37 Uehara R, Yashiro M, Nakamura Y, Yanagawa H. Kawasaki disease in parents and children. Acta Paediatr 2003;92:694–7. 38 Dergun M, Kao A, Hauger SB, Newburger JW, Burns JC. Familial occurrence of Kawasaki syndrome in North America. Arch Pediatr Adolesc Med 2005;159:876–81.
The rise and fall of the vaginal mesh SWATI JHA, CONSULTANT (O&G) AND HONORARY SENIOR CLINICAL LECTURER, SUBSPECIALIST IN UROGYNAECOLOGY, UK
..................................................................................................................................................................... Recent high profile cases involving use of vaginal meshes for treating pelvic organ prolapse (POP) and stress urinary incontinence include Christine Scott v. Kannappan ($5.5 million payout in July 2012) and Linda Gross v. Ethicon ($11.1 million payout in March 2013). Vaginal mesh manufacturers currently facing consolidated cases in US federal courts include Bard, Ethicon, Cook Medical, Coloplast, Boston Scientific Corp. and American Medical Systems. Several are allegedly considering settlements of several million pounds to compensate complications, loss of earnings and medical expenses. The use of vaginal meshes increased exponentially after their introduction into routine clinical practice in 2005, following only minimal testing based on the US FDA (Food and Drug Administration) 501 clearance method (a product predicated on an existing and approved device can forego the usually rigorous process of approval). Thus, the devices were introduced with minimal clinical safety trials. Vaginal meshes were believed to prevent recurrent prolapse, avoiding the one in three risk of needing further surgery over a lifetime following traditional primary prolapse surgery. Following rising reports of complications, in January 2012 the FDA ordered vaginal mesh manufacturers to perform postmarket surveillance studies (522 studies) to address safety and
1438
effectiveness concerns. Following this, Bard and Ethicon withdrew their vaginal prolapse meshes from the market; however, several other companies have commenced these studies in an unprecedented collaboration between industry, FDA and the American Urogynecologic Society and are striving to create a national prolapse surgery registry (Pelvic Floor Disorders Registry, PFDR). The ACOG, AUG, RANZGOG and in the UK, NICE (IP 267, 280-284), MHRA (Medicines and Healthcare Products Regulatory Agency), BSUG, BAUS and the Department of Health have now all issued guidance on the use of transvaginal meshes for POP, which is very similar. Neither the FDA nor the MHRA have declared an inherent problem with the device or with a single brand. The emphasis is on adequately trained clinicians performing these procedures, appropriate patient selection, discussion at an MDT, and informed consent from patients after reviewing the risks and benefits of the procedure as well as audit and monitoring of long-term outcomes on a recognised surgical database. Adverse events should be reported to a regulatory body. Standardised consent forms and patient information leaflets (available from the specialist societies) should be used. Surgery for removal of these meshes
where indicated should be undertaken in recognised specialist centres. Vaginal mesh POP repair introduces risks not present in traditional surgery. The Cochrane review on the use of synthetic mesh demonstrates that although effectiveness does not seem to be increased by the use of apical/ posterior vaginal wall mesh, use of the anterior and multiple compartments may offer some anatomical benefit. However, this may not equate to better symptomatic results and also brings to question whether the added risk is worth the additional benefit? The other issue is the ethics of depriving suitable patients this procedure due to clinician anxiety. These events should serve as a warning to early adopters and clinicians need to be prepared for greater scrutiny of their practice by the legal profession.
Disclosure of interests and funding SJ has received funding from Ethicon to conduct the UK National Prolapse Survey performed in 2004 and subsequently repeated in 2009. She is also on the Advisory board for Astellas. Contribution to authorship Conceived the article, did the literature search and wrote the article. &
ª 2014 Royal College of Obstetricians and Gynaecologists
