No one can deny that the contraceptive implant Essure has become quite the controversy over the past few years. The implant’s makers—Bayer—claim that the implant is a safe non-surgical alternative to other permanent contraceptive procedures. Yet, scores of women claim that the implant has caused them pain and suffering. Now, Bayer says it will discontinue the implant at the end of the year. Are consumer complaints the reason for this move?
Was Essure Discontinued Due to Injury Claims?
Since the FDA approved it in 2002, the Essure contraceptive has been gathering reports of injuries and side effects. From severe pain to uterine wall punctures, Essure has been blamed for all sorts of health issues. This has led to an estimated 16,000 lawsuits filed by women who believe their health problems can be traced to Essure.
The device uses nickel-coated titanium coils to block a woman’s fallopian tubes, preventing sperm from fertilizing the woman’s eggs. However, some women have reported getting pregnant after the device was implanted. Many of those pregnancies were ectopic, resulting in stillborn babies.
Due to similar complaints against Essure, it is no longer sold in the U.K., Europe, Canada, South America or South Africa. The United States is the last open market for Essure. That will end in December of this year.
Bayer claims its decision to stop sales of Essure was not due to growing safety concerns, but rather because of sales. Due to pressure from injured women all over the country, the Food and Drug Administration (FDA) forced Bayer to put a black box warning on Essure. In May, continued pressure resulted in the FDA requiring doctors and patients to review and sign off on a side effects checklist before the device can be implanted. Sales have steadily dropped for the contraceptive ever since the FDA’s regulatory actions.
So, was the discontinuation of Essure the result of falling sales or pressure from injured women? Many will continue to argue this point, but most see the move as a positive sign for the women who have filed lawsuits. Even more women are expected to file against Bayer, which is why contacting a lawyer may be a good idea for injured women. The pain and suffering caused by this medical device shouldn’t go unanswered, and our San Francisco product liability attorneys want to help.