Experts in FDA Regulation Opine on Essure Contraception

Cody Porcoro

Written by
on October 31, 2017

One woman’s lawsuit against manufacturers of the IUD permanent contraception device Essure necessitated an expert in the Food and Drug Administration’s medical device regulation. After the Essure device was implanted in her Fallopian Tubes, the woman began to experience abnormal uterine bleeding and excessive abdominal pain. An investigation revealed that the device had moved from her Fallopian Tubes to perforate her uterine wall, leaving her in critical medical condition. The focal point of the case hinged upon a discussion of the Essure manufacturing company, and whether they had potentially violated FDA regulations on market warnings and post-approval surveillance of devices.

Question(s) For Expert Witness

  • 1. Please briefly describe your medical device regulation experience.
  • 2. Do you feel comfortable discussing FDA regulations and requirements for a medical device post-approval?
  • 3. Can you speak to marketing and warnings concerns relevant to the FDA and device manufacturers?

Expert Witness Response E-063123

I have had extensive experience in this area, filing dozens of FDA correspondences, including both devices and drugs. I have lectured for the Food and Drug Law Institute on medical device regulation. I’ve been involved with extensive FDA correspondence meetings, on topics such as devices, women’s health, and adverse events. I feel comfortable commenting on FDA regulations and requirements for post-approval devices, as well as labels and warnings. I have published, lectured, and currently work in women’s health, and am well-versed on recent warnings that have come out regarding products in this area, including Essure.

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