According to numerous women, the birth control device called Essure, which needs to be implanted surgically, has led to numerous serious health problems. However, suing the manufacturers was impossible since the birth control had already been approved by the Food and Drug Administration (FDA). Congress members say that the time has to come to change this.
Holding the company responsible
Lawmakers claim that it is completely crazy that the manufacturers can’t be held responsible when the product is leading to health issues. Specifically, when the said product is a medical product that has the capability of causing health problems and deaths. Women who have used this birth control definitely agree to this.
Side effects and number of deaths
NewsChannel 5 Investigates started reporting about Essure and the related problems a couple of years ago. Since that time, complains about the detrimental side effects of the device have been registered by 25,000 or more women. Side effects include extreme pain in the abdomen and pelvic, damaged uterus, and migraines.
Mike Fitzpatrick, a US Representative, while addressing a news conference in Washington was astonished to learn that the birth control was responsible for the death of 300 unborn babies and four women.
Introduction of the legislation
At the time of approval by FDA, the manufacturers of Essure had received a pre-exemption status. According to this status, the manufacturers were not to be sued for any kind of problem that the device caused. Fitzpatrick, now, has introduced a new legislation according to which the system of reviewing medical devices will be changed. Additionally, the device would permit the victims to sue. The legislation has been named Ariel Grace’s Law. The legislation has been named after a girl who was born still because of the said device.
If the Ariel Grace Law passes, then it will not only be applied to the faulty device, but will also be applied to all the other medical devices available in the market. As of today, around 360,000 devices have the protected status from FDA. Thus, suing the manufacturers of these devices is impossible in the case where their product is either defective or unsafe.
Women made happy
With the introduction of the legislation, women are thrilled. According to women, the legislation would allow them to seek justice. The legislation would not only allow to hold the manufacturers responsible for deadly products but it will also be able to help all of those women that were hurt by the birth control system.