Medical Abortion with Mifepristone (RU-486)
Compared to Surgical Abortion

Martha Shuping
and Donna Harrison, M.D., Christopher Gacek, J.D., Ph.D.
April 16, 2007
Reproduced with Permission

More pain was reported with medical abortion both during the abortion and during the follow up period.1,2,3,4,5,6 (Jensen found 77.1% of medical abortion patients reported pain vs. 10.5% of surgical abortion patients.)7

More nausea or vomiting was reported both during the abortion and the follow up period after medical abortion compared to surgical abortion.8,9,10,11,12 (Post-abortion nausea in Jensen's study was 68.6% in medical abortion patients compared to 0.6% after surgical abortion).13

Higher failure rate was reported with medical abortion.14,15,16,17,18 Jensen reported 18.3% failure with medical abortion vs. 4.7 % failure after surgical abortion.19 Winikoff reported failure rates in China of 8.6% for medical and 0.4% for surgical abortions; in Cuba, 16.0% for medical and 4.0% for surgical; in India, 5.2% for medical and 0.0% for surgical abortions).20

Greater risk of acute bleeding requiring surgery with medical abortion: In Jensen's study, of women who required surgery after use of mifepristone, 12.5% underwent emergency surgery for acute bleeding, while no women in the surgical group required emergency surgery for acute bleeding.21,22

Postprocedure bleeding continues for a longer period of time with medical abortion,23,24 with a month of bleeding not unusual.25 In Jensen's study, bleeding continued for an average (mean) of 9.6 days longer for medical compared to surgical abortion patients.26 One U.S. study participant in a letter to the Los Angeles Times stated that she continued to bleed for three months after her mifepristone abortion.27 This is not unusual as the International Inquiry Commission on RU-486 expressed concern about uterine bleeding in over 90% of cases, lasting from 1 to 35 days.28 Dr. James McGregor, speaking at workshop sponsored by the U.S. Centers for Disease Control, discussed a study from 1986 in which "many patients had prolonged, over a month of abnormal bleeding,"29 causing authors to recommend "close medical supervision with mifepristone."30

More women required surgery for persistent bleeding after medical abortion compared to surgical abortion in Jensen's study.31 Of these women requiring surgery for persistent bleeding, the median was 35 days of bleeding before suction curettage was performed.32

More total blood loss has been reported with medical abortion compared to surgical.33,34,35,36 An FDA report stated mifepristone patients had "significantly more blood loss than did surgical patients."37

Massive, life-threatening hemorrhage has been reported after medical abortion. Gary and Harrison documented 116 women who required transfusions due to massive blood loss while undergoing mifepristone abortions.38 Harrison testified to a U.S. legislative committee: "At least 15 women (as of July 2005) lost over half of their blood volume."39 Hemorrhage severe enough to require transfusions was reported in 12%, and life-threatening hemorrhage was documented in at least 1.6% of the Adverse Event Reports.40,41 "In my experience as an ob-gyn, the volume of blood loss seen in the life-threatening cases is comparable to that observed in major surgical trauma cases like motor-vehicle accidents. This volume of blood loss is rarely seen in early surgical abortion without perforation of the uterus, and it is rarely seen in spontaneous abortions."42 The International Inquiry Commission on RU 486 has also raised concerns about bleeding severe enough to require emergency transfusion.43 The risk of hemorrhage from mifepristone abortions is much greater than from surgical abortion.44

The International Inquiry Commission on RU 486 raised concern regarding studies in which RU 486 had a strong stimulating effect on the growth of a breast cancer cell line.45

Mifepristone abortion has 10 times more risk of death from infection than surgical abortion46,47,48 and 50 times more risk of death from infection compared to childbirth.49,50

Mifepristone disrupts the innate immune system.51 This has been shown in animal studies where mifepristone blocked the immune response, increasing death rate from sepsis from 13% to 100%.52

There have now been six North American deaths from septic shock due to Clostridium sordellii in young women who have had medical abortion using mifepristone and misoprostol.53 "Mifepristone blocks human immune response through its effect on glucocorticoid receptors."54,55

Research presented at the Centers for Disease Control and Prevention (CDC) - FDA Workshop on "Emerging Clostridial Disease" supports a causal relationship mifepristone immune suppression and death from Clostridial sepsis.56,57

What U.S. Abortion Providers Are Saying about Medical Abortion with Mifepristone:

Dr. Damon Stutes, abortion provider in Reno, Nevada: "The complications associated with RU-486 far exceed the complications of surgical abortion."58

Dr. Warren Hern, abortion provider in Denver, Colorado: "I think surgery should be the procedure of choice." Dr. Hern also says that mifepristone abortions are riskier than surgical abortions.59

Dr. E. Hakim-Elahi, Elmhurst, New York, on Planned Parenthood's 2003 reported complications, in a letter to Ob.Gyn News: "If I were to receive such a report from a surgical abortion clinic, I would recommend to health authorities that the clinic be immediately shut down." Commenting on the medical abortion regimen in use at that time, he stated, "Medical abortion with the present drug regimen is unsafe." He points out, "The patient will bleed for the next 4 weeks or more, and may transmit HIV (if positive) to others; become anemic; require blood transfusions or surgical abortion; or get sepsis and die. This makes no sense. . . We are allowing women to get maimed and to die. . . . "60

Dr. Tom Tvedten, abortion provider in Little Rock Arkansas: "With medical termination, the discomfort is significant because they have to go through mini-labor. . . There's a lot of hard cramps and usually significant bleeding. It's cheaper, safer and less painful to have a surgical termination."61

Dr. Peter Bours, abortion provider, Portland, OR: "None of these women should be dying; it's shocking,"62


References:

1 Jensen JT, Astley SJ, Morgan E, Nichols MD. Outcomes of suction curettage and mifepristone abortion in the United States: a prospective comparison study. Contraception 1999;59:153-9 [Back]

2 Winikoff B, Sivin I, Coyaji KJ, et al. Safety, efficacy, and acceptability of medical abortion in China, Cuba, and India: a comparative trial of mifepristone and misoprostol versus surgical abortion. Am J Obstet Gynecol 1997;176:431-7. [Back]

3 Cabezas E. Medical versus surgical abortion. Internat J Gynaecol & Obstet. 1998;63 Supp. 1, S141-6. [Back]

4 Elul B, Ellertson C, Winikoff B, Coyaji K. Side effects of mifepristone-misoprostol abortion versus surgical abortion. Data from a trial in China, Cuba, and India. Contraception 1999;59(2):107-14. Available at http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10361625&dopt=Abstract (accessed March 25, 2007). [Back]

5 The FDA and RU-486: lowering the standard for women's health. Staff report prepared for the Hon. Mark Souder, Chariman, Subcommitte on Criminal Justice, Drug Policy and Human Resouces, October 2006. [Back]

6 Medical Officer's Review of Amendments 024 and 033, Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Commitments, Finalized November 22, 1999 (dated January 27, 2000), http://www.fda.gov/cder/foi/nda/2000/20687_Mifepristone_medr_P1.pdf (accessed March 25, 2007) [Back]

7 Jensen, et al., op. cit. [Back]

8 Ibid. [Back]

9 Winikoff, et al., op. cit [Back]

10 Cabezas op, cit. [Back]

11 The FDA and RU-486: lowering the standard for women's health, op. cit. [Back]

12 Medical Officer's Review of Amendments 024 and 033, Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Commitments, op. cit. [Back]

13 Jensen, op. cit. [Back]

14 Ibid. [Back]

15 Winikoff, et al., op. cit. [Back]

16 Medical Officer's Review of Amendments 024 and 033, Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Commitments, op. cit. [Back]

17 Cabezas op. cit. [Back]

18 The FDA and RU-486: lowering the standard for women's health, op cit. [Back]

19 Jensen, et al., op. cit. [Back]

20 Winikoff, et al., op. cit. [Back]

21 Jensen, et al., op. cit. [Back]

22 Harrison, D. Statement by Donna Harrison, M.D. before the House Subcommittee on Criminal Justice, Drug Policy and Human Res., Committee on Government Reform on RU-486: Demonstrating a low standard for women's health. 109th Congress (May 17, 2006). [Back]

23 Jensen, et al., op. cit. [Back]

24 Cabezas E. Medical versus surgical abortion, 63 Internat J. Gynecol. & OBstet. Supp. 1, S141, S144 (1999) [Back]

25 McGregor J, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed March 24, 2007), citing Couzimet and Beaulieu, The New England Journal, 1986. [Apparently Couzinet B, Le Strat N, Ulmann A, Baulieu EE, Schaison G. Termination of early pregnancy by the progesterone antagonist RU 486 (mifepristone). N Engl J Med 1986;315:1565- 70.] [Back]

26 Jensen, et al., op. cit. [Back]

27 The FDA and RU-486: lowering the standard for women's health, citing Los Angeles Times, May 6, 1990 at E-20. [Back]

28 The FDA and RU-486: lowering the standard for women's health, op. cit. [Back]

29 McGregor J, FDA: Emerging Clostridial Disease Workshop, Transcript, op. cit., citing Couzimet and Beaulieu, op. cit. [apparently Couzinet et al., op. cit.] [Back]

30 McGregor J, FDA: Emerging Clostridial Disease Workshop, Summary, May 11, 2006, Atlanta, GA. Available from: www.fda.gov/cder/meeting/clostridial/meeting_summary.pdf (accessed March 24, 2007), citing Couzimet and Beaulieu, op. cit. [Apparently Couzinet et al., op. cit.] Page 4 Shuping, Harrison, Gacek Medical Abortion with Mifepristone (RU-486) Compared to Surgical Abortion. [Back]

31 Jensen, et al., op. cit. [Back]

32 Ibid. [Back]

33 Chan YF, Ho PC, Ma HK. Blood loss in termination of early pregnancy by vacuum aspiration and by combination of mifepristone and gemeprost. Contraception 1993;47:85-95. [Back]

34 Elul et al., op cit. [Back]

35 The FDA and RU-486: lowering the standard for women's health, op. cit. [Back]

36 Medical Officer's Review of Amendments 024 and 033, Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Commitments, op.cit. [Back]

37 Ibid. [Back]

38 Gary MM, Harrison DJ. Analysis of severe adverse events related to the use of mifepristone as an abortifacient. Annals of Pharmacotherapy 2006;40(2):191-7 (published online Dec. 27, 2005) (www.theannals.com). [Back]

39 Harrison op. cit. [Back]

40 Ibid. [Back]

41 Gary MM, Harrison DJ, op. cit. [Back]

42 Harrison, op. cit. [Back]

43 The FDA and RU-486: lowering the standard for women's health, op. cit. [Back]

44 Harrison, op. cit. [Back]

45 The FDA and RU-486: lowering the standard for women's health, op. cit. [Back]

46 Harrison, op. cit. [Back]

47 McGregor J, FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: http://www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed March 24, 2007). [Back]

48 Greene MF. Fatal infections associated with mife-ristone-induced abortion. N Engl J Med 2005:353(22):2317-8 [Back]

49 Harrison, op.cit. [Back]

50 Fischer M. Fatal toxic shock syndrome associated with Clostridium sordellii after medical abortion. N Engl J Med 2005:353:2352-60 [Back]

51 Miech RP. Disruption of the innate immune system by mifepristone and lethal toxin of Clostridium sordellii. Journal of organ dysfunction; 2007, 1-5, i-First article. First Published on: February 19, 2007. DOI: 10.1080/17471060701200402 [Back]

52 Harrison, op. cit., citing, Sternberg E. Proceedings of the National Academy Sciences 1989;86:2374-78. [Back]

53 Gacek CM. Politicized science: the manipulated approval of RU-486 and its dangers to women's health. Family Research Council 2007. [Back]

54 Ibid. [Back]

55 Miech RP. Disruption of the innate immune system by mifepristone and lethal toxin of Clostridium sordellii. Journal of organ dysfunction; 2007, 1-5, i-First article. First Published on: February 19, 2007. DOI: 10.1080/17471060701200402 [Back]

56 Harrison [Back]

57 FDA: Emerging Clostridial Disease Workshop, Transcript, May 11, 2006, Atlanta, GA. Available from: www.fda.gov/cder/meeting/clostridial/meeting_transcrript.pdf (accessed March 24, 2007) [Back]

58 Gacek CM, op. cit, citing Harris, G. Some doctors voice worry over abortion pills' safety. New York Times. April 1, 2006, quoting Dr. Damen Stutes. Available from: http://www.nytimes.com/2006/04/01/health/01abort.html?ex=1301547600&en=77067caf1ced3fd2&ei=5088 (Accessed March 25, 2007). [Back]

59 Gacek CM, op. cit., citing Harris G. op. cit., quoting Dr. Warren Hern. [Back]

60 Hakim-Elahi E. Letter to the editor. Ob Gyn News (Feb. 15, 2005):6. Available from: http://www.findarticles.com/p/articles/mi_m0CYD/is_4_40/ai_n12416104 (Accessed March 25, 2007). [Back]

61 The FDA and RU-486: lowering the standard for women's health, op. cit., citing Leland J. Under din of abortion debate, an experience shared quietly, NY Times Sept. 18, 2005, quoting Dr. Tom Tvedten of Little Rock, Arkansas. [Back]

62 Gacek CM, op.cit., citing Harris G, op. cit., quoting Dr. Peter Bours. [Back]

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