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After women throughout the United States led the movement to raise awareness about the risk of severe and debilitating problems with Essure birth control coils, resulting in stronger FDA warnings last year, which were designed to make sure women are properly informed before undergoing the sterilization procedure, Bayer has removed Essure from the market outside the United States, but continues to sell the device to American women.
Bayer indicates that the decision to stop selling Essure coils outside the U.S. was made for “commercial reasons”, according to a press release issued in French on September 18. The manufacturer announced that it was ending sales of Essure throughout most of the world, but denies that the decision is based on the ongoing concerns over the safety of the birth control implant.
Essure is a medical device designed to provide permanent birth control or sterilization, which involves the placement of coils in the fallopian tubs that cause scar tissue to form and prevent pregnancy. However, thousands of women have suffered painful injuries when the coils migrated, perforated the uterus or fallopian tubes, caused allergic reactions, infections or other complications.
According to a report by massdevice.com, Bayer indicates that it will continue to market Essure in the U.S., claiming that the FDA recently evaluated the product and found a “favorable risk-benefit” profile.
In November 2016, following controversial hearings in the U.S. involving testimony from 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. The agency also required that women be provided with a checklist to make sure they are aware of the risks before undergoing an Essure coils procedure, and many medical experts suggest that no woman should elect to undergo the sterilization.
The device was temporarily withdrawn from the European market in August due to the safety concerns, and has been recalled in a number of countries across Europe. In late August, Australian health officials also announced that the implant would no longer be sold in that country, and now the manufacturer has decided that it will not market the product outside of the United States
Bayer currently faces Essure lawsuits brought on behalf of about 3,700 women in the United States, alleging the manufacturer has known about the serious risks and failed to adequately warn women and the medical community.
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.