The Essure Permanent Birth Control System was to provide women a safer, less involved (and painful) tubal ligation alternative. This medical device was triumphantly marketed as the “[only] FDA-approved permanent form of birth control with a procedure that can be performed in an office setting without general anesthesia.” Unfortunately for the 750,000 women who have used this system since the Food & Drug Administration (FDA) approved it in 2002, both new scientific research and anecdotal evidence suggest that Essure has caused substantial injuries to thousands of patients, motivating calls among consumer advocates for the drug’s recall and spurring legal action.
How Essure Works and Why the System Appeals to Women
The Essure system consists of two flexible coils that are inserted into the Fallopian tubes in order to produce permanent sterilization. Both patients and doctors have liked Essure, at least conceptually, because the system offers a less-invasive solution than tubal ligation and other birth control surgeries, ostensibly with shorter healing time and fewer side effects. Premarket studies tracked women’s pregnancies before and after Essure implantation, leading Bayer to assert that the device is 99.83 percent effective at preventing pregnancy and that “mild to moderate pain” and “spotting” are the most common side effects.
Alarming Studies and Anecdotes about Essure
Unfortunately, the facts may be more complicated than the product’s advocates publically admit. For instance, a New York Times expose reported: “The F.D.A. approved Essure after a fast-track review process that prioritized the device because it offered the first alternative to surgical sterilization and promised a quick recovery… Since then, the agency has received more than 4,000 reports of serious complications related to the device, including severe back and pelvic pain, heavy prolonged menstrual periods, and coils that pierced the fallopian tubes and lodged in other organs. According to a citizens’ petition filed with the F.D.A., an inspector was given records of 16,047 complaints made to the original manufacturer, Conceptus, between 2011 and 2013, when Bayer acquired a majority interest in the company.”
In light of these developments, many women have now filed lawsuits against Bayer, claiming that the system caused permanent pain and other damage. In September 2015, the FDA held a meeting to review the safety of this once-approved method of birth control – a meeting that was called after the agency realized it had received thousands of reports of adverse health effects from Essure.
Although Essure had been given conditional premarket approval (CPMA) by FDA, the CPMA was later invalidated, according to an Essure lawsuit filed in California. The lawsuit claims that the FDA invalidated the CPMA, rendering Essure “invalidated,” because Bayer failed to comply with two expressly stated conditions in the CPMA: that the company report any adverse events within 10 days of learning about them, and that that company report any information that the device had “caused or contributed to a serious injury.”
According to the FDA, Bayer failed to report eight separate cases of perforation that were brought to its attention. The FDA also alleged that the company failed to follow several safety and regulatory procedures in the manufacture of the Essure system. The patient in the California case was forced to have a hysterectomy, suffering all its attendant side effects, after years of experiencing inflammation and burning pain which appeared to be the result of the Essure system she had had implanted.
The legal language is an effort to get around preemption. Certainly, preemption is a complicated subject. But, simply put, Bayer is arguing that a key Supreme Court case has found that a law called the Medical Device Act prevents victims from bringing civil lawsuits involving medical devices that have received premarket approval from the FDA. Plaintiffs lawyers are trying to get around this ridiculous interpretation of the law by arguing that Bayer’s approval was invalidated by the conditions of pre-market approval. Will this work? It remains to be seen. The fight for justice women who have suffered from Essure is not over.
Help with Your Possible Essure Claim
If you or someone you love has experienced pain or severe side effects after using Essure, our experienced medical product liability attorneys offer strategic guidance. Call us today for a free and confidential consultation about your claim at 800-553-8082 or get a free on-line consultation.