Essure Recall Issued Ahead of Netflix Documentary

The medical device maker blamed declining sales, an overall decrease in the use of "permanent" contraception by women, and "inaccurate and misleading publicity about the device." Notably, this announcement comes about a week before the release of a Netflix documentary The Bleeding Edge, which highlights the health problems caused by medical devices like Essure. Filmmakers Kirby Dick and Amy Ziering issued a statement in response to Bayer's announcement, saying, "This is exactly why we do this work: This film has already changed policies and changed history."

While Bayer's statement does not name the Netflix documentary specifically as a reason for its decision to recall Essure, the company has been facing growing pressure from women who claim they have experienced severe side effects from the product. According to the company's most recent annual report, more than 16,100 women had filed Essure lawsuits as of January 2018. Given the upcoming documentary, it seems likely that the number of such lawsuits against the company could skyrocket, as more women discover that their birth control could be the source of previously unknown pain or medical problems.

Is Essure Dangerous?

In its recent announcement, Bayer insisted that its Essure birth control devices are safe and effective. "The FDA has maintained for several years that the benefits of Essure outweigh its risks," the pharmaceutical company said in its statement. It also highlighted that Essure is "the only FDA-approved non-incisional form of permanent birth control."

However, in April 2018, the U.S. Food and Drug Administration (FDA) restricted sales of the tubal ligation device to medical facilities and doctors who agreed to use a specific checklist that explicitly informed patients of the many possible side effects of the contraceptive. This is on top of previous actions taken by the regulatory agency in 2016 to add a black box warning to its label and require ongoing postmarket surveillance of the device's safety and effectiveness.

Despite the drugmaker's position, over a 15-year period from 2002 - 2017, the FDA received nearly 27,000 adverse event reports related to Essure. Side effects cited by the women who filed the reports include everything from abdominal pain and bleeding to unexpected weight loss and migration or dislocation of the device. More than 1,800 women became pregnant after the implant was inserted. In 2017, Bayer turned over more than 11,000 reports it had received from women complaining of similar side effects, though some of those reports may overlap with reports filed directly to the FDA.

Whether or not Essure is dangerous for women to use, it seems that more women are turning toward less permanent, removable options - including products like Mirena, which is also made by Bayer and has seen its share of problems, as well. While there are undoubtedly many reasons a woman could choose not to use a particular type of birth control, weighing the potential risks of suffering from a severe side effect is likely a significant one that goes into the equation.

What About the Essure Lawsuits?

Bayer did not attribute its decision to discontinue Essure to the thousands of lawsuits it is currently facing - and in fact, it did not even mention the litigation in its press release. To date, the company has not offered any kind of settlement to plaintiffs claiming Essure harmed them, and it appears that the company is going to continue fighting both existing and new lawsuits that arise.

Considering that the birth control implant is supposed to be "permanent," the company could continue to see new lawsuits for many years to come. If you or a loved one has experienced a severe side effect from an Essure contraceptive device, talk to a lawyer right away to get a free Essure case review and learn about your legal rights.