As thousands visit Essure injury lawyers to explore possibility of product liability lawsuit over Essure side effects, an advocacy group is seeking a Congressional probe into FDA oversight of the birth control device. The 30,000-strong Facebook group “Essure Problems” with hundreds of women who had harrowing tales to tell about Essure side effects has been vocal against the FDA’s failure to recall the contraceptive. It alleges that the FDA did not take into account the many reports of Essure injuries despite “inadequate and inappropriate clinical trials from the beginning.”
In a letter addressed to Jason Chaffet, who heads the Congressional Committee on Oversight and Government Reform, the group highlighted following potential reasons to believe that the FDA oversight of the Essure birth control is not up to the mark.
- Approval Without Sufficient Clinical Trials
The advocacy group claims that the FDA approved Essure without adequate clinical trials. Only two non-randomized, non-blinded studies were conducted. Of the 926 women selected, 181 dropped out and only a fourth subjects were followed for 2 years. There was no control group, which limited an effective assessment of the Essure side effects.
The post-marketing studies were also surrounded with controversies. According an article published in the New England Journal of Medicine, Essure birth control approval is an example of “lack of thorough examination, no well-conducted premarketing clinical trials, and absence of dedicated follow-up in post-marketing studies.” At least 27 women recruited for trials are now part of Essure Problems and openly discuss how the contraceptive forced them to suffer from complications, including post-placement surgery. There were also no trials to assess the side effects of PET fibers in the Essure coil.
- No Attention To Essure Side Effect Complaints
The FDA, according to Essure Problems, turned a blind eye to adverse event complaints. Despite 10,000 Essure side effect reports to the regulator and discovery of another 32,000 underreported incidents, it took no action. Making matters worse, the FDA did not comply with the request for a meeting by the advocacy group to discuss Essure injury facts for years.
The group even claims that medical reports of trials were altered and Essure side effect complaints were not acknowledged or reported. In 2016, the FDA admitted an error in reporting the problems associated with the birth control.
- Delay in Safety Warning
Despite thousands of Essure side effect complaints, the FDA delayed in issuing safety warnings. It admitted inaccurate reporting and intentional misrepresentation of safety data, but took no action. Even a November 2015 warning about “dangers of Lubricious Coating Separation” was not extended to Essure contraceptive coil.
Essure Problems also cites the FDA’s failure to rein in “highly aggressive marketing tactics” by the manufacturer making certain claims. The group has also highlighted business relationships between some in the top echelon of the FDA and manufacturers. It even questions the FDA’s failure to recall the birth control device after the February 2016 announcement of a required black box warning and more safety studies saying that such action puts “a whole new group of unsuspecting women on a path to being harmed by the device with absolutely no legal recourse.”
A study published in the British Medical Journal suggests that Essure side effects put users at a 10-fold risk of surgical treatment compared to laparoscopic sterilization. In the United States, thousands of women affected by complications linked to the contraceptive are considering the filing of a product liability claim.
Contact our Essure injury lawyer or call on 1-800-632-1404 for an evaluation of your product liability claim.