Your article about Essure (“Delayed scrutiny: Reported problems with birth-control device expose gaps in postmarket oversight,” July 27, p. 16) requires clarification.
All women deserve access to a wide range of safe and effective birth-control options. This includes women who have completed their families. As the only Food and Drug Administration-approved permanent birth control with a nonsurgical procedure, Essure is an important nonhormonal option for these women.
The article lacked context around some of my comments about Bayer's physician training on Essure. Basic hysteroscopy training is part of the core curriculum for all OB-GYN residency programs. In addition, Bayer provides robust training based on the Essure instructions for use, including patient selection, counseling, post-procedure management and proper placement steps to ensure the highest likelihood of successful placement of the device. Our instructions for use clearly state that Essure should be used only by physicians who are knowledgeable hysteroscopists. Bayer also provides ongoing support on the appropriate use of Essure and conducts continuous outreach to healthcare professionals about their experience and to answer their questions.
With respect to the comments in the article about Bayer's clinical data, the FDA has thoroughly reviewed the benefits and risks of Essure, and has confirmed that Essure is a safe and effective option for women when healthcare providers and patients follow the instructions for use. The FDA has evaluated available clinical literature and to date has found no conclusive evidence indicating any new or more widespread complications definitely associated with Essure occurring more than five years after placement.
As with any medical device or procedure, there are potential side effects. Any woman considering Essure should have an upfront discussion with her physician prior to selecting the product as her choice of contraception.
The safety and efficacy of Essure is supported by more than a decade of research and real world experience since the FDA's approval in 2002. The FDA is convening a meeting of its Obstetrics and Gynecology Devices Panel on Sept. 24 to seek expert scientific and clinical opinion on the benefits and risks of Essure. In line with our commitment to women's health, Bayer looks forward to this open dialogue with healthcare providers, patients and other stakeholders.
