November 16, 2015 · FLEMING | NOLEN | JEZ, L.L.P.
On November 4, 2015, 13 years after Essure® was approved, a U.S. Congressman introduced new legislation that seeks to remove the birth control device from the market.
Pennsylvania Congressman Mike Fitzpatrick presented the E-Free Act before the House of Representatives on Wednesday November 4. If passed, the bill would require the Food and Drug Administration to rescind their premarket approval of Essure® within 60 days of its passing. The FDA initially approved the medical device in 2002. Since then, thousands of women have filed complaints about complications arising from Essure®.
Marketed as a non-surgical, permanent sterilization device, Essure® has been sold to more than 1 million women worldwide. Of those, more than 5,000 women report complications such as pelvic pain, internal bleeding, and unexpected pregnancies. It is estimated that the device caused the death of four women and five unborn children. It is because of these significant statistics that Fitzpatrick looks to remove the device from the market.
In his address to Congress, the Congressman states,
This is a women’s issue, a safety issue, a regulatory issue… an issue with faces and names. I urge my colleagues to support this legislation and join me, and the thousands of women across the nation, in this fight.
The bill comes less than two months after the FDA held a public hearing on Essure®. Despite the lawsuits against them, Bayer HealthCare stands behind their product. They state the device is supported by research and science. They assert that after testing the device on 10,000 women, it was deemed safe for market approval.
Whether or not the bill passes, women support this move by Congressman Fitzpatrick. The legislation shows that Congress cares about what happens to the women affected by the device. It also demonstrates that the government is watching what the FDA is doing. This is sure to reassure the 23,000 supporters of the Essure Problems, an advocacy group against the device.
At Fleming | Nolen | Jez, LLP, we commend Rep. Fitzpatrick for his bold and necessary bill. We believe that too many have been harmed by the birth control device. If you or your loved one has had Essure® implanted and faced adverse effects, you may have grounds for compensation. Contact our medical device injury lawyers today for a free consultation.