Erin Brockovich, a woman made famous fighting on behalf of injured individuals against a large corporation, says she may have found her next project and it involves a potentially dangerous birth control device named Essure. Brockovich says that women who have been injured by the product are currently stranded with nowhere to turn for help all because of a FDA rule that protects companies at the expense of injured patients.
Essure is a method of permanent birth control that has been implanted in more than 750,000 women around the world. The device has been marketed on the claim that it is a safer way of preventing pregnancy than some risky alternatives such as tubal ligation. Essure is inserted into a woman’s fallopian tubes, supposedly working easily and safely to prevent pregnancy. The problem that many women have complained about is that the device can easily migrate or otherwise stop functioning as it should, leading to some serious complications.
One woman who had the device installed several years ago took to Facebook to complain and search for others who had suffered similar trouble. She talked about how she used to be an active mother, but now finds her self unable to laugh or sneeze without suffering through blinding pain followed by weeks of bleeding.
With symptoms this severe it would seem obvious that a lawsuit against Essure’s owner, Bayer, would be in order. However, injured women are discovering that their only recourse is to file an adverse event report with the FDA, something that more than 800 women have done regarding the Essure birth control device.
Many injured women were shocked to learn that an FDA regulation says that because Essure was submitted for pre-market trials and was ultimately approved by the agency, that the manufacturer is shielded from liability. The FDA says that Essure was subjected to two years of clinical trials before being sold to consumers, something Brockovich claims amounts to a fast-track that did not allow for enough information to be gathered about the product’s safety.
Brockovich says she was moved after hearing the stories of so many injured women and has now created a website for women to report harm from the device. She’s also calling on the FDA and elected officials to reconsider rules regarding preemption so that innocent victims of defective medical devices can pursue compensation for the harm they suffered.
If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please contact the Georgia product liability litigation attorneys at Pope, McGlamry P.C. today to schedule a free consultation.
Source: “Activist Erin Brockovich leading the fight against Essure birth control, wants FDA rules changed,” by Heather Catallo, published at WXYZ.com.