New Proposed Bills may Help Women Suffering Alleged Essure Injuries Find JusticeSep 26, 2016
Opponents of the Essure permanent birth control device say that the maker of the device, Bayer, has attempted to use pre-market approval rules to avoid liability in its manufacturing of the allegedly defective product. To date, thousands of women have filed lawsuits against Bayer alleging that Essure caused serious complications.
Recently, two new bills have been drafted that are hoped will support women who have been injured by Essure permanent female sterilization. The first bill is known as Ariel's Grace Law and was introduced by Congressman Mike Fitzpatrick and Congresswoman Louise Slaughter on June 8, 2016.
Ariel Grace was an unborn infant allegedly conceived due to an Essure failure and who died at 27 weeks of gestation. This law is meant to enable women suffering from Essure complications to hold its manufacturer legally liable and accountable for damages. Before this bill was drafted, pharmaceutical companies were unable to be pursued in court due to the 360K Premarket Approval Process.
The second bill is known as the Medical Device Guardian's Act of 2016 and was also introduced by Congressman Mike Fitzpatrick on the same day as Ariel's Grace Law was introduced. This bill is meant to enable physicians to have the freedom to report adverse events tied to the use medical device and will also protect doctors from personal liability and prosecution when they report medical devices failures.
The bill is also hoped to remove potential conflicts of interest. In the past, many hospitals allegedly discouraged doctors from reporting defective devices to avoid prosecution. This bill may also help assist regulators in recalling some of the most hazardous products on the market.
The Essure device received U.S. Food and Drug Administration (FDA) in late 2002. Complications have been reported shortly after approval.
Essure is constructed with two metal coils that are implanted through the vagina and in to the fallopian tubes. The body reacts with an inflammatory response that slowly builds scar tissue around these coils, which creates a barrier in the fallopian tubes that prevents sperm from fertilizing the egg. Meanwhile, women have reported suffering from device failure resulting in pregnancy, fatigue, headaches and migraine, heavy bleeding, metal allergies, nausea, organ perforation, and severe depression and suicidal thoughts, to name some.
The FDA convened an advisory panel to discuss the risks and benefits of Essure in 2015. The independent panel of experts concluded that there was not enough data to show that Essure is safe, and found that its use should be limited. The FDA has since added a so-called "Black Box" warning, its most severe warning, on the label of Essure devices cautioning physicians and patients of serious side effects associated with the use of the Essure fertilization method.