Bayer AG systematically failed to report thousands of complaints of injuries allegedly caused by its Essure birth control device to federal officials, according to recently unsealed court documents filed on behalf of tens of thousands of women who say the device injured them.
Failure to Report Essure Injuries
According to a report by the International Consortium of Investigative Journalists (ICIJ), the documents filed on behalf of plaintiffs in consolidated litigation in California include testimony from experts who conducted a statistical analysis of complaints by Essure patients. These documents allege that Bayer reported only a fraction of incidents in which patients said Essure had injured them.
Under federal law, manufacturers of medical devices are required to report injuries linked to their devices promptly to the U.S. Food and Drug Administration (FDA). One expert said that these failures to report were “systemic” and that they continued for nearly a decade, which means they were not simply isolated events. Bayer has dismissed the statistical analysis as “flawed.”
Essure Side Effects and Lawsuits
Essure is a contraceptive coil implanted in a woman’s fallopian tubes. The device causes scar tissue to form in the fallopian tubes, blocking sperm from reaching the egg and preventing pregnancy. It was first introduced to the U.S. market in 2002 by Conceptus. Since then, it has been the subject of tens of thousands of complaints from women who have reported a number of severe side effects including intense pain, bleeding, organ damage and migration of the device inside the body.
More than 27,000 women in California alone have filed lawsuits against Bayer, consolidated in Alameda Superior Court. According to ICIJ, more than 16,000 complaints about Essure were made to its manufacturer between 2008 and 2019, but only 183 incidents were reported to the FDA during that period.
In such cases, manufacturers of defective products must be held accountable. When it comes to defective medical devices, it is all the more important for manufacturers to report problems and warn consumers because these products go into patients’ bodies and could have serious, sometimes life-threatening, health consequences.
Suppose you or a loved one has been injured due to getting Essure. In that case, you must seek the counsel of an experienced product defect lawyer who will fight for your rights and help you secure maximum compensation for your losses, including medical expenses, lost income, cost of hospitalization, pain and suffering and emotional distress.
Source: https://www.icij.org/investigations/implant-files/essure-injury-complaints-buried-by-bayer-lawsuit-claims/
