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According to a new investigative report, Bayer paid doctors $2.5 million in consulting fees linked to the Essure birth control implant, which is now being pulled from the market amid thousands of reports involving painful and debilitating complications among women who underwent the procedure, raising questions about whether the payments improperly influenced doctor recommendations.
The CNN exclusive report indicates that many of the doctors who received the biggest payments from Bayer, were also the device’s biggest cheerleaders, and some patients interviewed for the story said their doctors aggressively pushed the devices for permanent birth control.
The payments were made to 11,850 doctors from August 2013 through December 2017, with at least three doctors paid in excess of $100,000. Most patients were likely unaware of the financial connections when doctors recommended Essure birth control procedures as a permanent way to avoid pregnancy.
The revelation came a day after Netflix aired “The Bleeding Edge“, a documentary about the dangers of potentially unsafe medical technology and how it has being approved in the United States. Essure is spotlighted in the documentary, which describes the devastating reports of intense pain, bleeding, allergic reactions and other complications experienced by thousands of women.
On the same day the documentary was released, Bayer issued an “Open Letter” (PDF) to patients and doctors, saying that it stands behind the safety of Essure and that reported problems are misleading and inaccurate publicity.
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 have confirmed that 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.
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.
On July 20, Bayer announced it was removing Essure from the U.S. market for marketing reasons on December 31, 2018. It had already removed Essure from the market in the rest of the world last year.
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.
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.