While still battling thousands of Roundup Lawsuits, Bayer is now under fire for underreporting thousands of complaints of injuries originated from its Essure contraception device to the U.S. Food and Drug Administration, according to unsealed documents.
After acquiring Essure from Conceptus, Bayer AG continued the company’s practice of not reporting complaints to the FDA. This is according to unsealed court filings by the lead attorney in thousands of lawsuits by women in California.
Essure was marketed as a safe and nonsurgical approach to tying the fallopian tubes. However, because Bayer failed in its reporting obligations, the FDA was unaware of updates to the warnings needed. The FDA finally put restrictions on the device once it received a significant amount of complaints that Essure caused bleeding, organ damage, and pain for users. The device was off the U.S. market in 2018, a year after it was pulled from other markets.
Prior to the Bayer acquisition, Conceptus had an accumulation of complaints that continued to grow after Bayer started selling the product. Back in 2008, an internal audit performed by an independent consulting firm advised that there might be too many unresolved complaints that would violate the FDA requirements.
Bayer Essure complaints included the following:
- Failure by Conceptus to report instances when Essure was removed because of pain unless it was determined as “medically necessary.”
- Failure by Conceptus to report complaints related to Essure if symptoms weren’t relieved after removal.
- Conceptus did not investigate complaints from patients.
- Bayer not wanting to report Conceptus’ complaints that are identified as reportable by its criteria.
Bayer fought to keep the documents sealed and said in a statement that the FDA had inspected its reporting practices and complaint-handling but didn’t issue a warning letter of these practices.
The Carlson Law Firm Can Help
If you or someone has used the Essure contraceptive, call a Dangerous Drugs Lawyer from The Carlson Law Firm. We can help hold Bayer accountable for injuries you or your loved have suffered as a result of Bayer’s negligence.