June 16, 2016 · FLEMING | NOLEN | JEZ, L.L.P.
Essure® birth control — a form of permanent birth control — has come under quite a bit of scrutiny lately as more and more women are coming forward with complaints of adverse effects. According to patients, the implant has caused issues such as perforation, extensive bleeding, and even unplanned births. Unfortunately, because of the way Essure® was approved by the United States Food and Drug Administration (FDA), taking legal action on behalf of these women has proven to be a difficult task. Luckily, this could potentially change in the future thanks to members of Congress.
Lawmakers are considering a new legislation to allow women harmed by Essure® to take action against Bayer, the makers of the contraceptive. This is a day that many women have been waiting for which would eliminate legal hurdles to holding the company liable for issues caused by their medical device. Essure® has been linked to numerous health complications.
The Essure® birth control consists of coils that are implanted into the fallopian tubes. They work by producing scar tissue, essentially blocking the fallopian tubes and making reproduction impossible. At least, so they thought. Along with the other issues listed, there have been reports of women getting pregnant even after receiving the Essure® birth control.
This device has been under investigation for years now, with more than 25,000 women reporting issues associated with the Essure® birth control, including migraines, stomach pains, pelvic pains, and damage to important organs including the uterus. In some cases, removal is impossible to do without the need for a hysterectomy. These are serious situations.
Now, United States Representative Mike Fitzpatrick (R-Penn.) released the following statement,
Every once and a while there’s a medical device that will get approved through either a fast track approval or a more rigorous approval that may do more harm than good — and that’s what we’re here to talk about.
Fitzpatrick spoke at a conference last week and was alarmed at the number of people who have been harmed by Essure®, including at least four women who have died, as well as roughly 300 unborn children. Fitzpatrick has introduced new legislation to make changes regarding how medical devices are reviewed by the FDA. Furthermore, the legislation would give those harmed an easier way to pursue legal action.
Currently, there are roughly 360,000 devices approved by the FDA through the pre-market approval process. This approval process makes it difficult for individuals injured by product defects or unsafe products.
At Fleming | Nolen | Jez, L.L.P., our Essure® attorneys have filed lawsuits on behalf of women that have been injured by Essure®. We are looking forward to seeing how this plays out and helping even more women who have suffered from the serious side effects associated with the Essure® device. You shouldn’t have to suffer from a defective or dangerous product, and our team will work hard on your behalf to help you obtain the justice you deserve.
If you have the Essure® device, we encourage you to contact our team and learn what options you may have.