Bayer Accused of Withholding Essure Complaints From FDA

Bayer Accused of Withholding Essure Complaints From FDA

Bayer AG allegedly withheld thousands of injury complaints from the United States Food and Drug Administration (FDA) about their birth control device, Essure. Essure is a popular contraceptive device that thousands of women claim is causing them severe injuries and complications. Because of this, many lawsuits are developing against Bayer AG for failing to warn of the possible complications.

According to unsealed documents, Bayer underreported the number of injury complaints made by women to the United States Food and Drug Administration (FDA). According to the filing, “It was Bayer’s failures to comply with the reporting obligations that made it impossible for the FDA to know that updates to Essure’s warnings were needed”.

Bayer marketed Essure as a safe alternative to surgery, in order to stop pregnancy. But after further research and reports, the FDA put restrictions on Essure after receiving reports of bleeding, pain, and damage it was causing numerous women.

Bayer stands by their product saying “they stand behind Essure’s safety and efficacy” as the lawsuits for their device continues. Conceptus, the original manufacturer of Essure before Bayer bought them, was allegedly the responsible party for withholding Essure complaints from the FDA. This included:

  • Failing to report instances where Essure devices were removed due to pain unless the removal was “medically necessary”.
  • Conceptus also had a history of not reporting complaints related to Essure if symptoms did not improve after removal.
  • They also had a history of not investigating complaints coming directly from patients.
  • Additionally, Bayer did not report Conceptus’s complaints that qualified under its criteria.

What is Essure?

Essure is a permanently implanted birth control device used by women that were introduced in 2002. It is in the shape of a metal coil that professionals insert into the fallopian tubes nonsurgically to prevent pregnancy. The sterilization works by creating scar tissue around the fallopian tubes which prevents sperm from reaching the egg. Furthermore, Essure was one of the top mass tort cases trending in 2020, with more and more women coming forward with their complaints.

After multiple years of use, many women began claiming that Essure was causing them pain and problems. According to reports from the FDA, From January 2017 through December 2018, there were 11,854 medical device reports related to Essure in 2017 and 6,000 reports in 2018. From the reports, 85% of the devices were removed from patients which are also known as “device removal reports”.

The top six reported reasons in the device removal reports were:

  • Pain: 60%
  • Genital hemorrhage: 14%
  • Device dislocation/migration/expulsion: 12%
  • Perforation: 11%
  • Suspected allergy to metals: 4%
  • Device breakage: 3%

Why is Essure Allegedly Causing Harm?

After many years of being on the market, Essure is allegedly dangerous and harmful to the women that use it. In the Essure lawsuits, many women have reported that they have suffered from many things such as:

  • Mild to moderate pain during and immediately following the Essure placement procedure.
  • Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort immediately after the procedure.
  • Abdominal, pelvic, or back pain
  • Tear or hole (perforation) of the uterus or fallopian tubes
  • Unintended pregnancy
  • Allergy or hypersensitivity reactions
  • Essure inserts unexpectedly moved to the abdominal or pelvic cavity
  • If a patient and health care provider decides to remove Essure, another surgery may be required.
  • Headache
  • Feeling tired (fatigue)
  • Weight changes
  • Hair loss
  • Mood changes, including depression

What is Happening with Essure now?

Because of the many lawsuits filed against Bayer for their Essure product, Bayer has discontinued the product. In December 2018, Bayer stopped selling and distributing the Essure device in the United States. However, Bayer or the FDA did not recall the Essure device.  After one year, all unused Essure units were ordered to be returned to Bayer. But women that already had it implanted were allowed to continue to use it.

Currently, there is no MDL (Multi-District Litigation) for the Essure lawsuits in the federal court system. However, there are many plaintiffs active in consolidated lawsuits against the manufacturers of Essure.

In January 2020, an Indiana court ruled in favor of 30 women who are proceeding to sue Bayer for their Essure birth control device. These women claimed they suffered from many health problems resulting from using the Essure birth control device.

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