There are new calls for action against a birth control device that some say is dangerous and harmful to women.
Women across the country have reported numerous health problems which they claim were related to the birth control device “Essure.” Now a Pennsylvania congressman is speaking out, claiming he’s also uncovered hundreds of unreported deaths.
Essure is a metal coil implanted into a woman’s Fallopian tubes that’s designed to block pregnancy. Tamara Monroe of Levittown told NBC10 she immediately experienced problems when she used it.
“It was a horrible experience,” Monroe said. “I had a lot of fatigue, brain fog, weight gain, very bad abdominal pain, heavy bleeding.”
Monroe isn’t the only one who reported a bad experience with the device. A Facebook Page devoted to complaints about Essure has more than 27,000 followers. Those complaints drew the attention of Bucks County-based congressman Mike Fitzpatrick (R-Pa. 8th District).
On Wednesday, Fitzpatrick announced he was pushing to have Essure pulled from the market until further safety studies are done. He also called on the Food and Drug Administration (FDA) to pull its approval.
“Women are being harmed,” Fitzpatrick said. “Citizens are being harmed.”
Local
Breaking news and the stories that matter to your neighborhood.
Fitzpatrick claimed the FDA did not adequately follow up on the device after complaints were made. Fitzpatrick also said there are massive inconsistencies regarding the number of deaths linked to Essure.
“They’ve been telling me that with respect to Essure there have been five fetal deaths,” Fitzpatrick said. “If you actually read the narratives of those reports that have been filed, those complains, the number exceeds 300.”
At a recent FDA hearing about the device, several doctors spoke in favor of Essure. Bayer HealthCare, the maker of the device, also sent NBC10 a statement on Fitzpatrick’s comments:
“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.”
