A US Congressman says a controversial birth control device has caused hundreds more fetal deaths than the FDA has publicly reported.
Congressman Mike Fitzpatrick (R-Pa.) says an independent report reveals 303 fetal deaths caused by Essure. According to the FDA’s public database that tracks “adverse events,” the agency has only cited 5 deaths related to Essure.
Rep. Fitzpatrick wrote a letter to the FDA saying, “in light of this immense discrepancy, I request that the FDA conduct a thorough review” as part of the agencies current investigation into whether Essure should be taken off the market.
Essure is marketed as an alternative to tubal ligation that can be performed in a doctor’s office.
Thousands of women here in Michigan and across the country complain of severe pain, miscarriages, and serious injuries. In some cases, the metal coils of Essure, which are used to permanently block conception, have cut into other organs.
In September, several women testified at a special FDA panel hearing, urging them to take Essure off the market. An FDA review of Essure is currently underway, and should wrap up this month.
“I’m hoping that they will pull it off the market immediately to save future women. The ones that are suffering now, many of them have become hopeless due to no insurance, the ability not to work anymore because of the sickness. They’re suffering as far as their families being moms, just every day chores and situations are very difficult for them,” Detroit mother Darlene Taylor recently told 7 Investigator Heather Catallo.
Rep. Fitzpatrick also announced today that he has received an unsealed complaint from a federal lawsuit against Bayer Healthcare, which owns Conceptus, the creator of Essure. Fitzpatrick says the complaint alleges that the manufacturer “provided illegal kickbacks in the form of free medical equipment valued at $20,000.”
He says more than 25,000 women have reported severe symptoms, prompting Fitzpatrick to introduce legislation called the E-Free Act. If the bill passes, it would force the Food and Drug Administration to take Essure off the market. Ten thousand women have filed formal complained with the FDA about the birth control device.
Here is Bayer’s 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 Technology1 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.