Long-Acting Methods of Contraception
http://www.100md.com
《新英格兰医药杂志》
To the Editor: In the review of long-acting methods of contraception by Peterson and Curtis (Nov. 17 issue),1 the discussion of hysteroscopic tubal sterilization was limited to a single, addendum-like sentence. Moreover, the authors seemed to ignore the procedure when they discussed the complications and risks of tubal sterilization and when they concluded, "vasectomy . . . is safer."
Contrary to the impression given by the authors, tubal sterilization no longer requires general anesthesia, incisions, or operating rooms.2,3 Hysteroscopic tubal sterilization is not what might be called a "concept procedure" of the future. It is here now. Hysteroscopic tubal sterilization is safer and better tolerated than laparoscopic tubal sterilization and easily rivals vasectomy for all outcomes.
James A. Greenberg, M.D.
Brigham and Women's Hospital
Boston, MA 02115
jagreenberg@partners.org
References
Peterson HB, Curtis KM. Long-acting methods of contraception. N Engl J Med 2005;353:2169-2175.
Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure pbc clinical study. Aust N Z J Obstet Gynaecol 2001;41:364-370.
Ubeda A, Labastida R, Dexeus S. Essure: a new device for hysteroscopic tubal sterilization in an outpatient setting. Fertil Steril 2004;82:196-199.
To the Editor: I was surprised that Peterson and Curtis dismissed any adverse effect of progestin implants on bone density by citing a review published in 2002.1 Multiple studies2,3,4 have documented bone loss with prolonged use, which is a special concern in adolescents and young women during a time of life when maximal bone mass is usually being attained. Although the long-term consequence of this bone loss has not yet been defined, the evidence was sufficient to prompt the Food and Drug Administration (FDA) in 2004 to require a black-box warning advising against long-term use as a contraceptive in young women. That warning has led many young women or their primary care providers to discontinue the therapy. If the authors do not think that this is an important effect of progestin implants, a more detailed explanation would appear appropriate.
David H. Sarne, M.D.
University of Illinois at Chicago
Chicago, IL 60612
dhsarne@uic.edu
Dr. Sarne reports owning equity in Johnson & Johnson.
References
Curtis KM. Safety of implantable contraceptives for women: data from observational studies. Contraception 2002;65:85-96.
Scholes D, LaCroix AZ, Ichikawa LE, Barlow WE, Ott SM. Change in bone mineral density among adolescent women using and discontinuing medroxyprogesterone acetate contraception. Arch Pediatr Adolesc Med 2005;159:139-144.
Cromer BA, Stager M, Bonny A, et al. Depot medroxyprogesterone acetate, oral contraceptives and bone mineral density in a cohort of adolescent girls. J Adolesc Health 2004;35:434-441.
Berenson AB, Breitkopf CR, Grady JJ, Rickert VI, Thomas A. Effect of hormonal contraception on bone mineral density after 24 months of use. Obstet Gynecol 2004;103:899-906.
The authors reply: In response to Dr. Greenberg, we certainly did not intend to give the new hysteroscopic tubal-sterilization procedure short shrift (nor did we characterize it as a "concept procedure"). Space limitations precluded our being able to discuss any method of tubal occlusion in detail, but Dr. Greenberg's comment gives us the opportunity to say more about this new option, which, as he points out, has attractive safety features. The hysteroscopic approach has the important advantages of eliminating the need for both general anesthesia and entry into the abdominal cavity.1 Nonetheless, care must be taken to avert potential complications of this approach, including fluid overload and uterine perforation. Tubal occlusion must be confirmed by hysterosalpingography at three months after the placement of the microinserts into the fallopian tubes, and alternative contraception should be used until occlusion is documented. Although this method is too new to have generated data regarding long-term safety and effectiveness, findings from the initial clinical trials suggest that the method is highly effective for at least several years.
Dr. Sarne expresses concern regarding the potential adverse effect of progestin implants on bone mass, particularly with long-term use among adolescents and young women. However, both the studies that he cites and the FDA's black-box warning2 refer to the use of injectable depot medroxyprogesterone acetate (DMPA). Although DMPA use does indeed lead to a hypoestrogenic state that may affect bone mass, use of progestin-only implants does not appear to do the same. We indicated in our introduction that we were not including methods (such as injectable contraceptives) that require frequent effort for effectiveness. Rather, we reviewed longer-acting methods, including progestin-only implants that contain progestins such as levonorgestrel or etonogestrel and that provide ongoing contraception for several years with a single insertion. As we noted, the available data to date showed no evidence of loss of bone mass with these implants. In June 2005, the World Health Organization consultation on steroid hormones and bone mass concluded that data on progestin-only implants suggest no adverse effects on bone mineral density.3
Herbert B. Peterson, M.D.
University of North Carolina at Chapel Hill
Chapel Hill, NC 27599
herbert_peterson@unc.edu
Kathryn M. Curtis, Ph.D.
Centers for Disease Control and Prevention
Atlanta, GA 30341
References
Cooper JM, Carignan CS, Cher D, Kerin JF. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol 2003;102:59-67.
Black box warning added concerning long-term use of Depo-Provera Contraceptive Injection. Rockville, Md.: Food and Drug Administration, November 2004. (Accessed January 19, 2006, at http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html.)
WHO statement on hormonal contraception and bone health. Geneva: World Health Organization, June 2005. (Accessed January 19, 2006, at http://www.who.int/reproductive-health/family_planning/docs/hormonal_contraception_bone_health.pdf.)
Contrary to the impression given by the authors, tubal sterilization no longer requires general anesthesia, incisions, or operating rooms.2,3 Hysteroscopic tubal sterilization is not what might be called a "concept procedure" of the future. It is here now. Hysteroscopic tubal sterilization is safer and better tolerated than laparoscopic tubal sterilization and easily rivals vasectomy for all outcomes.
James A. Greenberg, M.D.
Brigham and Women's Hospital
Boston, MA 02115
jagreenberg@partners.org
References
Peterson HB, Curtis KM. Long-acting methods of contraception. N Engl J Med 2005;353:2169-2175.
Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure pbc clinical study. Aust N Z J Obstet Gynaecol 2001;41:364-370.
Ubeda A, Labastida R, Dexeus S. Essure: a new device for hysteroscopic tubal sterilization in an outpatient setting. Fertil Steril 2004;82:196-199.
To the Editor: I was surprised that Peterson and Curtis dismissed any adverse effect of progestin implants on bone density by citing a review published in 2002.1 Multiple studies2,3,4 have documented bone loss with prolonged use, which is a special concern in adolescents and young women during a time of life when maximal bone mass is usually being attained. Although the long-term consequence of this bone loss has not yet been defined, the evidence was sufficient to prompt the Food and Drug Administration (FDA) in 2004 to require a black-box warning advising against long-term use as a contraceptive in young women. That warning has led many young women or their primary care providers to discontinue the therapy. If the authors do not think that this is an important effect of progestin implants, a more detailed explanation would appear appropriate.
David H. Sarne, M.D.
University of Illinois at Chicago
Chicago, IL 60612
dhsarne@uic.edu
Dr. Sarne reports owning equity in Johnson & Johnson.
References
Curtis KM. Safety of implantable contraceptives for women: data from observational studies. Contraception 2002;65:85-96.
Scholes D, LaCroix AZ, Ichikawa LE, Barlow WE, Ott SM. Change in bone mineral density among adolescent women using and discontinuing medroxyprogesterone acetate contraception. Arch Pediatr Adolesc Med 2005;159:139-144.
Cromer BA, Stager M, Bonny A, et al. Depot medroxyprogesterone acetate, oral contraceptives and bone mineral density in a cohort of adolescent girls. J Adolesc Health 2004;35:434-441.
Berenson AB, Breitkopf CR, Grady JJ, Rickert VI, Thomas A. Effect of hormonal contraception on bone mineral density after 24 months of use. Obstet Gynecol 2004;103:899-906.
The authors reply: In response to Dr. Greenberg, we certainly did not intend to give the new hysteroscopic tubal-sterilization procedure short shrift (nor did we characterize it as a "concept procedure"). Space limitations precluded our being able to discuss any method of tubal occlusion in detail, but Dr. Greenberg's comment gives us the opportunity to say more about this new option, which, as he points out, has attractive safety features. The hysteroscopic approach has the important advantages of eliminating the need for both general anesthesia and entry into the abdominal cavity.1 Nonetheless, care must be taken to avert potential complications of this approach, including fluid overload and uterine perforation. Tubal occlusion must be confirmed by hysterosalpingography at three months after the placement of the microinserts into the fallopian tubes, and alternative contraception should be used until occlusion is documented. Although this method is too new to have generated data regarding long-term safety and effectiveness, findings from the initial clinical trials suggest that the method is highly effective for at least several years.
Dr. Sarne expresses concern regarding the potential adverse effect of progestin implants on bone mass, particularly with long-term use among adolescents and young women. However, both the studies that he cites and the FDA's black-box warning2 refer to the use of injectable depot medroxyprogesterone acetate (DMPA). Although DMPA use does indeed lead to a hypoestrogenic state that may affect bone mass, use of progestin-only implants does not appear to do the same. We indicated in our introduction that we were not including methods (such as injectable contraceptives) that require frequent effort for effectiveness. Rather, we reviewed longer-acting methods, including progestin-only implants that contain progestins such as levonorgestrel or etonogestrel and that provide ongoing contraception for several years with a single insertion. As we noted, the available data to date showed no evidence of loss of bone mass with these implants. In June 2005, the World Health Organization consultation on steroid hormones and bone mass concluded that data on progestin-only implants suggest no adverse effects on bone mineral density.3
Herbert B. Peterson, M.D.
University of North Carolina at Chapel Hill
Chapel Hill, NC 27599
herbert_peterson@unc.edu
Kathryn M. Curtis, Ph.D.
Centers for Disease Control and Prevention
Atlanta, GA 30341
References
Cooper JM, Carignan CS, Cher D, Kerin JF. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol 2003;102:59-67.
Black box warning added concerning long-term use of Depo-Provera Contraceptive Injection. Rockville, Md.: Food and Drug Administration, November 2004. (Accessed January 19, 2006, at http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html.)
WHO statement on hormonal contraception and bone health. Geneva: World Health Organization, June 2005. (Accessed January 19, 2006, at http://www.who.int/reproductive-health/family_planning/docs/hormonal_contraception_bone_health.pdf.)