Wednesday, Bayer HealthCare responded to charges from U.S. Rep. Mike Fitzpatrick that women who had used the contraception product Essure had far more fetal deaths than had been reported.
Here is the company's full response:
“We are aware that Congressman Mike Fitzpatrick held a press briefing on February 17th related to Essure permanent birth control.
“It is not true that an investigation revealed “unreported” deaths with Essure. Bayer reports adverse events to FDA consistent with FDA regulations. The referenced data is also publicly-available. While no method of contraception can offer 100% efficacy, Essure offers women a highly effective method of permanent birth control. Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications. It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term. In the post-market data, there is no data showing any increased risk of miscarriage and other complications compared to pregnancies in similar-age populations. Ectopic pregnancies and blighted ovum are not considered fetal deaths and can occur for a multitude of reasons not related to Essure. Moreover, the medical literature on pregnancy outcomes with Essure primarily comes from closely-monitored, desired pregnancies after Assisted Reproductive Technology* and does not report high rates of premature membrane rupture, preterm labor or delivery, or serious complications.
“The Congressman's statements repeat unfounded allegations from an unsealed legal or “qui tam” complaint. These allegations were made over a year ago and the United States Department of Justice thoroughly investigated them. After its investigation, DOJ declined to intervene and prosecute the case. The qui tam plaintiff also voluntarily dismissed the case. DOJ has closed its investigation. The matter is now fully concluded.
“Bayer is also aware of quotes on the number of members of a private Facebook group. It is unreliable to cite that number of group members as if it were the number of Essure patients experiencing adverse events from the device. Without transparency, the public cannot confirm how many members of the page are Essure patients, let alone confirm the nature of their health complaints, if any.
“As the federal authority responsible for assessing the continued safety and efficacy of medicines and devices, FDA held a meeting of the Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee in September to seek expert advice on the safe and appropriate use of Essure. Contrary to other reports, the post-market data disclosed and discussed at this meeting did include ectopic pregnancy and preterm pregnancy complications. There was agreement among the Panel members that Essure is an important contraceptive option and the Panel provided advice for FDA and Bayer to consider. We anticipate FDA to release a communication on that discussion by the end of this month.
“Choice of contraception and the decision to use a permanent method is a very personal one that should be made between a woman, her partner and her healthcare provider. Not every option is right for every woman. This is why choice is so critical. Tubal ligation and, actually, pregnancy itself, carry risks, which can be serious.
“Bayer is particularly concerned about statements that may be creating an atmosphere of unfounded fear, or that may be encouraging women who are not experiencing adverse symptoms from Essure to seek removal of Essure. The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure was first developed.”
*Essure is not indicated or labeled for use in this manner. Essure is approved by the FDA for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes. Bayer does not promote or endorse off-label use of any of our products. We encourage healthcare providers to refer to the FDA-approved Instructions for Use (IFU) available here to guide appropriate use of the product.