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The recent decision made by Bayer Healthcare to withdraw Essure birth control implants from the U.S. market came just days before a documentary is set to air on Netflix, which will highlight serious complications linked to the permanent contraceptive coils, raising questions about whether the company was trying to avoid bad publicity.
Netflix is set to release “The Bleeding Edge” tomorrow, which is a documentary highlighting the risks associated with certain medical technology. Essure complications are advertised as one of the central examples of new devices that caused devastating injuries.
The Bleeding Edge was created by the makers of “The Hunting Ground” and “The Invisible War”, and looks at high risk implanted devices, the problems they cause, and why most never undergo any clinical trials to make sure they are safe and effective before being widely marketed to consumers and the medical community. In addition to the Essure implant, the documentary will also look at hip replacement complications and vaginal mesh problems.
The timing of Bayer’s recent announcement that it is removing Essure from U.S. markets at the end of the year has raised some questions, as the company has been pushing back against substantial pressure from consumer and safety to have the device pulled, due to devastating injuries thousands of women have suffered.
Essure was introduced as a form of permanent protection against pregnancy, involving an outpatient procedure where coils are placed in the uterus, which develop scar tissue that prevent pregnancy. However, the device has been linked to painful and debilitating injuries when the coils migrated, perforated the uterus or Fallopian tubes, caused allergic reactions, infections or other complications.
FDA officials say the agency received about 12,000 adverse event reports related to the Essure birth control implant last year. In April, the FDA made changes to Essure’s premarket approval, requiring both doctors and patients to sign off on a checklist of potential Essure complications.
Bayer currently faces several thousand Essure lawsuits brought on behalf of women who have been left with devastating injuries, each raising similar allegations that the company manufactured and sold an unreasonably dangerous and defective sterilization product, withholding information about the risks associated with the procedure.
Last year, Essure was withdrawn from every other market in the world, except the United States. However, in May, after Gottlieb met with a number of women who claimed they were injured by the device, the FDA added new restrictions to Essure procedures, indicating that both the doctor and the patient must sign off on a checklist of potential problems, to ensure that the patient is fully informed about the risks.
In November 2016, following controversial hearings in the U.S., where testimony was heard from large numbers of women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry.
Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.
The manufacturer has reportedly spent about $413 million defending the Essure litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.