The FDA has labeled Bayer's post-marketing surveillance of its Essure birth control implants as inadequate due to a high rate of women dropping out of the study.
Thousands more reports of Essure adverse events were submitted to the FDA in 2021, with most involving reports of surgical removal of the device due to problems.
The FDA indicates nearly 2% of all women who were implanted with an Essure birth control device suffered organ perforation injuries.
Bayer's final report on Essure complications indicates nearly 60,000 women reported serious injuries and at least 115 died due to Essure birth control implant complications.
The FDA is seeking input on how it can improve medical implant labeling to warn patients of potential adverse reactions to the materials used in those devices, following problems with…
A new Essure report suggests as many as 19 women have died due to problems with the recalled birth control implant.
Bayer reports it received nearly 12,000 medical reports linked to the Essure birth control implant, which is no longer sold on the market, in the second half of 2020.
A new report on Essure injuries indicates Bayer has received more than 7,000 reports of serious injuries and reports of 73 deaths associated with the birth control implant.
A lawsuit against Bayer claims an Essure birth control implant broke inside a woman's body and punctured her internal organs after migrating out of position.
An Essure lawsuit claims the birth control device, broke, migrated out of position, and punctured organs and caused infections in an Alabama woman.
