FDA in No Rush to Prove Essure Risks
This is Amy German, Managing associate attorney for The Michael Brady Lynch Firm.
After 10,000 reports of harmful side effects from Essure, the FDA mandated that Bayer, the Essure manufacturer needs to perform a new study concentrating on the harmful side of effects of the device. Lawmakers and the public are outraged that not only has Bayer finally submitted its proposal for the study almost a year later, but also the FDA is giving Bayer to the year 2023 – seven years — to complete it. Most FDA trials last only 6 months to two years, but the FDA gave Bayer triple that amount of time.
Essure was once touted as the best option for permanent birth control. During an office visit, a doctor would insert metal coils into a woman’s ovarian canal, which would develop enough scar tissue to block the release of an egg. However, many women are reporting that the coils will migrate and perforate organs or even the uterine wall.
The FDA sees this risk since the organization issued Essure a black box warning in February and now the demand for another study. If Essure is so dangerous, why are they not issuing a product recall until the study’s completion? Seven years is a long time for women to unknowingly choose this form of birth control without knowing all the facts.
It is for this reason that lawmakers like Rep. Mike Fitzpatrick (R-PA) are taking a stand. He thinks the FDA is causing female consumers serious harm in this neglectful attitude. Rep. Fitzpatrick is sponsoring a bill for the FDA to revoke its approval of Essure. Fitzpatrick said it was “unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market.”
Contact us today.
At The Michael Brady Lynch Firm, we believe patients should be given the facts to make an informed decision. We will fight to make sure you won’t be victimized again. If you or a loved one have been a victim of Essure, please call us at 877-513-9517.