Essure FDA InvestigationMarch 23, 2016
What is a clear sign that Essure birth control devices are defective? The U.S. Food and Drug Administration is launching a probe of the contraceptive device. This Essure FDA investigation began in mid-April of 2015 and also concerns alleged deceit by Essure manufacturer Bayer Healthcare Pharmaceuticals Inc.
A petition which was filed on behalf of hundreds of victims of Essure alleges that Bayer used defective materials in Essure’s manufacturing, failed to report adverse Essure side effects, altered and falsified medical records to the point of fraud during Essure clinical trials and deceived the FDA and the public about Essure’s efficacy and safety.
The petition also demands an Essure recall, which Bayer has so far failed to do despite many reports of injuries.
Indeed, the women making the petition have reportedly suffered such injuries as having the birth control implant migrate from the fallopian tubes as well as perforate other organs. Such women also report pain due to the defective device.
In addition, five lawsuits also been filed in Pennsylvania challenging Essure and Bayer, which claims it “stands behind” the device’s safety and efficacy and will “aggressively defend itself in court.”
The petition also claims that Bayer violated the premarket approval terms of the FDA along with violating federal laws.
What is Essure?
As for what is Essure, it’s a tiny flexible coil which is inserted into fallopian tubes via the uterus and cervix, after which it deliberately creates inflammation in order to block the fallopian tubes permanently — thus preventing conception — within about three months after insertion.
Essure was approved by the FDA in November of 2002. Its marketing has included emphases on its ease of insertion in a physician’s office rather than a hospital. Yet insertion can be difficult, and many physicians are not skilled in the process, requiring several attempts.
Essure originally was designed, made and marketed by Conceptus Inc., which Bayer purchased in 2013. Bayer is now fully responsible for Essure’s defects.
Adverse Events Reporting Failures
The FDA will investigate the petition’s claim that Bayer had adverse events reporting failures, failing to report such things as Essure coils breaking up into tiny pieces, bowels being perforated and coils migrating away from the fallopian tubes.
Reportedly Bayer revealed to the FDA only 22 perforations despite having data on 168 perforations. Bayer also reportedly had an internal file with over 16,000 complaints about Essure which it did not reveal to the FDA.
Clinical Trial Fraud
The FDA also will investigate clinical trial fraud in terms of the data collected. The petitioners claim that Bayer changed at least two patients’ medical records during these trials.
It’s asserted that one patient’s birth date on a questionnaire was changed to make her seem to be 20 years older, thus conforming to the FDA’s requirement for premarket approval. It’s assert that another woman’s questionnaire was changed to delete her complaint about pain and health problems due to Essure and to add that she’d had no pain or health problems.
Misleading Claims on Efficacy and Safety
The petition filed with the FDA also alleges Bayer made misleading claims on efficacy and safety of the Essure birth control device. In fact, it alleges such claims included not just misleading claims, but false information on many occasions.
The petition asserts that four pregnancies occurred in clinical trials and at least five during Essure’s first year of commercial use, despite the fact that Essure’s entire job is to prevent conception. The petition also asserts that Bayer claimed no pregnancies occurred during clinical trials.
Defective Manufacturing Materials
It’s also asserted that Bayer failed to “identify existing and potential causes of non-conforming product and other quality problems.” The possibility of defective manufacturing materials is raised.
The petition also asserts that Bayer claimed Essure was 100 per cent effective as a birth control device. According to the FDA itself, “no form of birth control is 100 per cent effective.”
Seek an Essure Lawsuit Attorney
If you were injured by a defective Essure device, seek an Essure lawsuit attorney to handle your case. We invite you to contact the Willis Law Firm, where we will speedily provide you with a free legal consultation which will be completely confidential. Then you can decide how you want to proceed.
You may be legally entitled to substantial financial compensation for your Essure birth control injury.© Willis Law Firm for Drug Attorneys. Replication strictly prohibited without written consent.