Essure Regulatory Fight Hits a Roadblock
A recent blog on the Philly.com website examined proposed regulatory action involving the Essure permanent birth control device. If successful, it could have forced the device off the market completely. However, even though the effort has stalled, women harmed by after using Essure may still have legal recourse.
The Essure device first gained FDA approval in 2002 to provide a permanent, non-surgical option to women who no longer wanted to have children. However, thousands of women have reported medical complications after having the device inserted, including painful menstruation and sexual intercourse, device migration into the abdomen and pelvis, and many others. Thousands of women have filed lawsuits against Essure manufacturers for serious side effects and injuries.
Fighting the Good Fight
Essure gained what is known as “pre-market approval” (PMA) from the FDA, which is granted to medical devices that have no identifiable prior products on the market . As a result, Bayer, the manufacturer of Essure, is largely protected from litigation.
But Congressman Mike Fitzpatrick of Pennsylvania is seeking to change that. In November, he introduced legislation to force the FDA to take Essure off the market. His bill was rejected – according to the blog, due to technicalities. As a result, it is not expected to come up for a vote in the House of Representatives.
All is Not Lost
Even though Rep. Fitzpatrick’s efforts have so far proven unsuccessful, that does not mean they cannot be revived at a later date. The public can do a great deal to revive this legislation by making their voices heard. Contact your local Congressional representative and let him or her know how you feel.