Bayer and a group of filmmakers are sparring over safety issues with the Essure birth control implant, following the release of a documentary that highlights the device’s quick development and severe adverse events suffered by thousands of women had it implanted in their bodies for permanent sterilization.
On July 27, Netflix released a new documentary called “The Bleeding Edge” which outlines concerns about the rapid development of invasive medical implants and the risks to consumers. The Essure implant was spotlighted during the film.
Just one week before the film’s release, on July 20, Bayer announced it was recalling Essure from the U.S. market on December 31, 2018, indicating that the decision was made for marketing reasons. The company had already recalled Essure from the market in the rest of the world last year amid serious safety concerns, but has continued to market and sell the device here.
Essure provides permanent protection against pregnancy, involving an outpatient procedure where coils are placed in the uterus. Scar tissue develops on the coils, which prevents pregnancy. However, questions have emerged about the safety of the design, which 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.
On the same day the documentary was released on Netflix, Bayer published an “open letter” (PDF) to patients and providers, defending Essure’s safety profile. The company claimed that scientific studies prove Essure’s benefits and safety, and that the data has been ignored by critics.
“Over the last few years, Essure has been the subject of conversation on both social and mainstream media platforms. The concerns raised about Essure are based primarily on anecdotal reports from individual patients,” the letter states. “Bayer takes all such reports seriously. It is important to understand, however, that anecdotal reports have limitations. While such reports can raise questions about potential issues with a product, they do not provide answers. Such questions can only be answered through evidence-based medicine, including clinical trials and observational studies.”
In a response released published in Variety, the filmmakers fired back, pointing out that the clinical trials Bayer refers to were shallow and poorly constructed.
“The truth is that Essure was rushed to market under an ‘expedited review,’ based only on two poorly constructed studies that weren’t randomized or non-blinded and that lacked comparator groups,” the filmmakers said. “These studies followed most participants for only 18 months, even though Essure is supposed to remain implanted for a woman’s lifetime.”
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.
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.