The FDA has launched an investigation against Bayer Healthcare Pharmaceuticals, over the injuries allegedly caused by their permanent contraceptive product, Essure.

According to the investigation, Bayer allegedly falsified and altered medical records during clinical trials, failed to report possible side effects, and had deceived the public and FDA about the overall safety of the device.

Additionally, Bayer Pharmaceuticals had allegedly used defective materials when making the Essure birth control product.

This investigation was launched by a petition filed by a law firm that specializes in product-liability claims, on behalf of hundreds of women who claimed they suffered adverse effects like organ perforation, device migration from the fallopian tubes, and pain.

There are currently five lawsuits filed in Pennsylvania from these victims, with Bayer stating that it would defend itself throughout the litigation, along with any other allegations.

Several petitioners have asked the FDA to issue an order to Bayer Pharmaceuticals to initiate a recall of Essure. The petitioners state that based on the fact that this product seemed to be marketed on falsified information, and that Bayer violated federal laws and the terms of the FDA’s pre-market approval, that Essure should be recalled from the market.

Dr. William H. Maisel, chief scientist of the FDA’s Center for Devices and Radiological Health (CDRH), replied that the agency will pursue corrective actions if necessary. However, Dr. Maisel also stated that the CDRH does not provide any information discovered during the investigation, nor does it provide any explanations of the investigation outcomes, to the person or group who filed the complaint.

Overview of Essure Complications

The Essure birth control device was approved by the FDA in 2002 to be a permanent contraceptive for women. The Essure is a small flexible coil that is inserted into the fallopian tube through the cervix by a medical professional.

Essure works by permanently blocking the fallopian tube by causing inflammation. It is a slow process that can take up to three months after insertion. While Bayer is not the original manufacturing company of Essure, Bayer acquired the rights for Essure when it purchased the company, Conceptus, in 2013.

Essure, however, had been approved by the FDA through a fast-track review protocol because it was the first permanent contraceptive method that did not involve surgery.

Currently, Essure is the only non-surgical sterilization option for women, and has even been boasted to be a safer alternative to tubal ligation. Many women and the petitioners heavily dispute that claim, stating that Essure was approved before the risks of the device had been adequately explored.

Specifically, the petitioners claim that Bayer had altered the medical records of at least two patients during clinical trials, when one of the patients reported she suffered pain. In another patient’s case, her date of birth was reportedly changed from March 27, 1976 to March 27, 1956 in order to conform to the FDA’s pre-market approval requirements.

Other injuries the company allegedly hid include perforated bowels, device coils breaking into pieces, and Essure coils migrating out of the fallopian tubes.

Overall, Bayer has been accused of withholding 146 perforation reports, after only disclosing 22 to the FDA. Furthermore, Bayer is alleged to have an internal excel file that contains 16,047 entries of product complaints, none of which were given to the FDA.

But the allegations do not end there; five pregnancies reportedly occurred in women who used Essure birth control during its first commercial year, with Bayer allegedly being aware of up to 64 pregnancies that occurred between 1997 and 2005.

Essentially, the petitioners allege that Bayer had only been concerned about the market success of Essure and had concealed all this vital information to prevent a downturn in sales.

Despite the allegations made by the petitioners, Bayer still maintains that Essure is perfectly safe and is the best alternative to female surgical sterilization. The company is predicted to defend itself against all Essure allegations.

At this point, the FDA has closed the petition and has forwarded it to the Office of Compliance. In the meantime, lawyers predict that more women will file Essure lawsuits against Bayer, alleging similar injuries mentioned in the petition.