Helping Women Find Justice
Tens of thousands of women allege they suffered severe health complications after using Essure, including perforation of the fallopian tubes, extreme pain during sex, expulsion and migration of the device, failure of the device, and more. As of now, however, the device’s PMA status protects Bayer from lawsuits except under a narrow set of grounds. These include failure to warn healthcare providers and patients of the alleged dangers of the device as well as negligent misrepresentation of Essure. The FDA grants PMA status to devices that, in the agency’s opinion, have shown to be safe and effective through clinical trials.
If the bill (which was introduced by Rep. Mike Fitzpatrick of Pennsylvania) passes, women will be able to sue on many other counts.
Another bill also under consideration in the House is known as “Ariel Grace’s Law.” While this is related to Essure, it is more general in scope in that it would allow anyone injured by a medical device granted PMA protection to file a lawsuit against the manufacturer.
The law is named for a baby who was stillborn following failure of the Essure device. Ariel Grace’s mother was diagnosed with a placental abruption, an instance where the womb becomes detached from the placenta. Fitzpatrick, who introduced this bill as well, alleges that Essure caused the condition that led to the baby’s death.