Joint Essure Lawsuit Claims Bayer Serious Injury and Complication Reports From FDA
Following years of organic reports emerging on the internet and social media about serious injuries and complications from Essure birth control, a lawsuit recently filed against Bayer by a group of two dozen women alleges that the manufacturer actively withheld information about the huge number of women who were experiencing problems after Essure coils were implanted.
The complaint (PDF) was filed in the U.S. District Court for the Eastern District of Pennsylvania on April 22, involving claims on behalf of 24 different women who indicate that they suffered painful and debilitating injuries due to the design of the birth control implant.
Essure is a form of permanent sterilization offered as an out-patient procedure, where bendable coils are placed into the fallopian tubes. The procedures causes scar tissue to form around the coils and block the tubes.
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Although it is marketed as a safe and effective means of preventing pregnancy, thousands of women have surfaced in recent years on Facebook, Twitter and other websites describing problems where the coils migrated, perforated the uterus, caused severe allergic reactions, infections, abdominal pain and other problems.
The plaintiffs in this recently filed complaint allege that Bayer failed to provide adequate warnings for women and the medical community about the risk of Essure problems, and indicate that adverse event reports submitted by women nationwide were purposefully withheld and hidden from the FDA to deceive the agency about the safety and effectiveness of Essure birth control coils, making it an adulterated product under federal law.
According to the lawsuit, FDA investigators have found that only 22 incidents of Essure perforation of women’s organs were reported to the agency, although the company had knowledge of 144 of such incidents. The lawsuit also claims the FDA found that Bayer did not report cases of the Essure migrating out of position, reports of coils breaking into pieces, and did not analyze or identify causes of quality problems.
The complaint points out that in May 2013, the FDA uncovered an internal spreadsheet that contained over 16,000 entries involving complaints that were not properly reported to the FDA, which indicated that Essure coils migrated outside of the fallopian tube. Bayer allegedly argued that these reports were not disclosed since their last contact with the women suggested they were no longer experiencing pain, describing the problems as “mere trial damage that does not rise to the level of a serious injury.”
Plaintiffs indicate that they never would have had Essure implanted for birth control if they had been aware of the number and scope of problems associated with the device.
Essure Injury Litigation
The case joins a growing number of Essure lawsuits filed in recent months, each involving similar allegations that Bayer failed to adequately warn about the risk of problems and withheld information from consumers, doctors and federal regulators.
Last year, the FDA held advisory panel meetings to review the safety of Essure. After considering recommendations from the panel of outside experts, the FDA announced in late February 2016 that much stronger Essure warnings will be required to make sure doctors and women are informed of the potential risks.
Although the product has been sold for the past 14 years, Bayer has also been ordered to conduct additional studies to better understand the safety of the Essure implant, raising questions about why the manufacturer failed to take these steps years ago after receiving complaints.
An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.
As Essure injury lawyers continue to review and file potential cases for women nationwide, it is ultimately expected that Bayer could face hundreds, if not thousands, of lawsuits in courts throughout the U.S.
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