of labour following 39 weeks of gestation. She had had a lower-segment cesarean section a year before because of placenta previa and toxemia of pregnancy. After a short trial of labour the fetal heart rate decreased to 80 beats/mm while the patient complained of sharp abdominal pains and nausea, and vomited. Possible causes were thought to be rupture of the cesarean section scar, placenta abruptio or umbilical cord around the neck of the fetus. Cesarean section was carried out. About 200 ml of blood was present in the pelvis. The lower segment scar, although not torn, was very thin. A live baby with one loop of the cord around the neck was delivered. The placenta was normal in location and was delivered complete. The uterus, tubes and ovaries showed no abnormality. No fresh bleeding was seen. The patient did well until 10 hours postoperatively, when severe abdominal pain developed; she collapsed and died despite cardiopulmonary resuscitative measures. Autopsy revealed a large amount of clotted and free blood in the peritoneal cavity and hilar region of the spleen, extending into the lesser sac of the pentoneum. A ruptured aneurysmal sac 2.5 cm in diameter was found in the splenic artery approximately 10 cm from the artery's origin. Splenic artery aneurysms have been detected at 0.02 to 0.05% of complete autopsies.3'4 Of the 67% in females4 58% were in women of childbearing age. The frequency of rupture of the aneurysm has been reported as 9.2. % In one study 20% of all reported ruptures had occurred during pregnancy,6 but in another study all but 1 of 77 cases of splenic artery aneurysm in pregnancy were associated with rupture.7 Calcified aneurysms rarely rupture; only four such cases have been reported.8 Mortality after rupture has been variously reported as 25 to 46% in nonpregnant patients and 68 to 80% in pregnant women, with a fetal mortality of over 90% . Only three cases were reported in which both mother and child survived.'1 The proportions of ruptures according to stage of the pregnancy have been cited as follows: 1st trimester, 2%; 2nd trimester, 10%; 3rd trimester, 69%; labour, 13%; and puerperium, 6% .12 While the exact cause of splenic artery aneurysm is unknown, pregnancy apparently is important in precipitating rupture. Changes in mucopolysaccharides, hormonal factors, local hemodynamics and strains of labour may be responsible. Toxemia of pregnancy does not seem to be significant. In the reported cases in pregnant women the size of the aneurysm has usually ranged from 2 to 4 cm. Double rupture, as in my patient, occurs in about 20% of pregnant women with splenic artery aneurysms'2 and about 21 % of a gen-
eral group of patients with these aneurysms.4 Diagnosis is extremely difficult. In nonpregnant patients diagnostic measures should include arteriography. Chalmers'3 attributed his success in making the diagnosis preoperatively to the fact that he had just read Ogden's report.'4 The generally accepted treatment of choice for patients of childbearing age discovered to have a splenic artery aneurysm is splenectomy plus excision of the aneurysm. Physicians should be aware of the possibility of splenic artery aneurysm in pregnant women with abdominal pain, for the diagnosis depends ultimately on thinking of the condition. WAN C. Ho, MD, FRcs[C] 20438 Douglas Cres. Langley, BC
References 1. BEAUSSIER M: Sur un an.vrisme de l'art.re splenique dont les parois se sont ossifi6es.
I Med Clin Pharmacol 32: 157, 1770 2. CoRsoN EM: Aneurysm of the splenic artery: rupture and death. M & S Reporter 20: 351, 1869 3. Snai's SG, SPITTEL JA JR, FAIRBAIRN iF ii,
et al: Aneurysms of the splenic artery with special reference to bland aneurysms. Proc
Staff Meet Mayo Cli,, 33: 381, 1958 4. OWENS IC, Cosua. RI: Collective review: aneurysm of splenic artery, including report of 6 additional cases. mt Abstr Surg 97: 313, 1953 5. SPITTEL IA JR, FAIRsAIRN IF ii, KINCAID OW,
et al: Aneurysm of the splenic artery. JAMA
175: 452, 1961
6. VASSALOTTI SB, SCHALLER IA: Spontaneous rupture of splenic artery aneurysm in pregnancy. Report of first known antepartum rupture with maternal and fetal survival.
Obstet Gynecol 30: 264, 1967 7. STANLEY IC, FRY WI: Pathogenesis and clinical significance of splenic artery aneurysms. Surgery 76: 898, 1974 8. WEsTcoI-r IL, ZrrER FMH . Aneurysms of the splenic artery. Surg Gynecol Obstet 136: 541, 1973 9. SCHUG T, RANKIN RP: Rupture of a splenic artery in pregnancy: report of a summary and review of literature. Obstet Gynecol 25: 717, 1965
10. MooRa SW, GUIDA RM, SCHUMACHER HW: Splenic artery aneurysm. Bull Soc mt Chir 29: 210, 1970 11. GissENs D, HEATH D: Ruptured aneurysm of splenic artery in pregnancy (C). Br Med I 4: 103, 1974 12. MACFARLANE IR, THORBJARNARSON B: Rupture of splenic arterial aneurysm during
pregnancy. Am I Obstet Gynecol 95: 1025, 1966
13. CHALMERS IA: Rupture of splenic arterial aneurysm as fatal complication of pregnancy.
Br I Surg 37: 86, 1949 14. OGDEN 1K: Retroperitoneal haemorrhage in pregnancy. Br Med 1 1: 389, 1948
The only tests in common use in North America are those described in the "United States Pharmacopeia XIX" under the heading "Biological tests plastic containers". However, these tests were designed for a different purpose and are not adequate for implant materials. Various organizations and individuals are designing appropriate biocompatibility tests. The bureau has decided to review the present state of the art and try to define what needs to be done in some organized fashion. Standard- writing organizations have been contacted, and Dr. Walter Zingg, Hospital for Sick Children, Toronto, has agreed to organize the study. We invite comments and suggestions from organizations and individuals on the development of methods for testing biocompatibility in the area defined as follows: * Long-term implants, medical and dental (excluding external materials in contact with the skin but including denture materials). * Polymers, both preformed and formed in situ (excluding metals). * Tests of interaction between living tissue and implanted materials (local effects). * Tests of interaction between host and implanted materials (general effects; excluding tests of physical performance but including assessment of elimination of breakdown products of the implant). Comments will be reviewed by the staff of the bureau and by clinical consultants, and may provide a basis for further studies. Letters may be addressed to either of the undersigned. R.W. CAMPBELL, MB, CH B Division of medicine Bureau of medical devices Health and Welfare Canada Environmental Health Centre Tunney's Pasture Ottawa, Ont. KIA 0L2
WALTER ZINOG, MD, ERCs[CJ
Research Institute Hospital for Sick Children 555 University Ave. Toronto, Ont. M5G 1X8
Biocompatibility tests for implant Doctors and torture materials To the editor: The editorial entitled To the editor: The bureau of medical devices of Health and Welfare Canada is charged under the Food and Drugs Act with the responsibility for ensuring that medical devices sold in Canada are safe and effective for their intended use. Biocompatibility of the materials used is one of the major concerns in evaluating devices, particularly implants intended for long-term use.
126 CMA JOURNAL/JULY 23, 1977/VOL. 117
"Doctors, torture and abuse of the doctor-patient relationship" by Dr. Earl M. Cooperman (Can Med Assoc J 116: 707, 1977) was very informative. Dr. Cooperman took as an example of resistance against a dictatorship the underground resistance of Dutch physicians against the "Nazification" of Hol. land during World War II. I have some comments to make on the background of that resistance.
eral group of patients with these aneurysms.4 Diagnosis is extremely difficult. In nonpregnant patients diagnostic measures should include arteriography. Chalmers'3 attributed his success in making the diagnosis preoperatively to the fact that he had just read Ogden's report.'4 The generally accepted treatment of choice for patients of childbearing age discovered to have a splenic artery aneurysm is splenectomy plus excision of the aneurysm. Physicians should be aware of the possibility of splenic artery aneurysm in pregnant women with abdominal pain, for the diagnosis depends ultimately on thinking of the condition. WAN C. Ho, MD, FRcs[C] 20438 Douglas Cres. Langley, BC
References 1. BEAUSSIER M: Sur un an.vrisme de l'art.re splenique dont les parois se sont ossifi6es.
I Med Clin Pharmacol 32: 157, 1770 2. CoRsoN EM: Aneurysm of the splenic artery: rupture and death. M & S Reporter 20: 351, 1869 3. Snai's SG, SPITTEL JA JR, FAIRBAIRN iF ii,
et al: Aneurysms of the splenic artery with special reference to bland aneurysms. Proc
Staff Meet Mayo Cli,, 33: 381, 1958 4. OWENS IC, Cosua. RI: Collective review: aneurysm of splenic artery, including report of 6 additional cases. mt Abstr Surg 97: 313, 1953 5. SPITTEL IA JR, FAIRsAIRN IF ii, KINCAID OW,
et al: Aneurysm of the splenic artery. JAMA
175: 452, 1961
6. VASSALOTTI SB, SCHALLER IA: Spontaneous rupture of splenic artery aneurysm in pregnancy. Report of first known antepartum rupture with maternal and fetal survival.
Obstet Gynecol 30: 264, 1967 7. STANLEY IC, FRY WI: Pathogenesis and clinical significance of splenic artery aneurysms. Surgery 76: 898, 1974 8. WEsTcoI-r IL, ZrrER FMH . Aneurysms of the splenic artery. Surg Gynecol Obstet 136: 541, 1973 9. SCHUG T, RANKIN RP: Rupture of a splenic artery in pregnancy: report of a summary and review of literature. Obstet Gynecol 25: 717, 1965
10. MooRa SW, GUIDA RM, SCHUMACHER HW: Splenic artery aneurysm. Bull Soc mt Chir 29: 210, 1970 11. GissENs D, HEATH D: Ruptured aneurysm of splenic artery in pregnancy (C). Br Med I 4: 103, 1974 12. MACFARLANE IR, THORBJARNARSON B: Rupture of splenic arterial aneurysm during
pregnancy. Am I Obstet Gynecol 95: 1025, 1966
13. CHALMERS IA: Rupture of splenic arterial aneurysm as fatal complication of pregnancy.
Br I Surg 37: 86, 1949 14. OGDEN 1K: Retroperitoneal haemorrhage in pregnancy. Br Med 1 1: 389, 1948
The only tests in common use in North America are those described in the "United States Pharmacopeia XIX" under the heading "Biological tests plastic containers". However, these tests were designed for a different purpose and are not adequate for implant materials. Various organizations and individuals are designing appropriate biocompatibility tests. The bureau has decided to review the present state of the art and try to define what needs to be done in some organized fashion. Standard- writing organizations have been contacted, and Dr. Walter Zingg, Hospital for Sick Children, Toronto, has agreed to organize the study. We invite comments and suggestions from organizations and individuals on the development of methods for testing biocompatibility in the area defined as follows: * Long-term implants, medical and dental (excluding external materials in contact with the skin but including denture materials). * Polymers, both preformed and formed in situ (excluding metals). * Tests of interaction between living tissue and implanted materials (local effects). * Tests of interaction between host and implanted materials (general effects; excluding tests of physical performance but including assessment of elimination of breakdown products of the implant). Comments will be reviewed by the staff of the bureau and by clinical consultants, and may provide a basis for further studies. Letters may be addressed to either of the undersigned. R.W. CAMPBELL, MB, CH B Division of medicine Bureau of medical devices Health and Welfare Canada Environmental Health Centre Tunney's Pasture Ottawa, Ont. KIA 0L2
WALTER ZINOG, MD, ERCs[CJ
Research Institute Hospital for Sick Children 555 University Ave. Toronto, Ont. M5G 1X8
Biocompatibility tests for implant Doctors and torture materials To the editor: The editorial entitled To the editor: The bureau of medical devices of Health and Welfare Canada is charged under the Food and Drugs Act with the responsibility for ensuring that medical devices sold in Canada are safe and effective for their intended use. Biocompatibility of the materials used is one of the major concerns in evaluating devices, particularly implants intended for long-term use.
126 CMA JOURNAL/JULY 23, 1977/VOL. 117
"Doctors, torture and abuse of the doctor-patient relationship" by Dr. Earl M. Cooperman (Can Med Assoc J 116: 707, 1977) was very informative. Dr. Cooperman took as an example of resistance against a dictatorship the underground resistance of Dutch physicians against the "Nazification" of Hol. land during World War II. I have some comments to make on the background of that resistance.
