FDA Approval of Essure Contraceptive Implants Questioned in New Case

Cody Porcoro

Written by
on October 31, 2017

Essure, the only available permanent contraceptive measure that does not involve invasive surgery, was brought into a class action case of six women who suffered a host of complications from the device. Though Essure’s manufacturer managed to obtain pre-approval from the FDA that isolated it from direct lawsuits, the case at hand worked directly to invalidate the company’s immunity by alleging that the product had been developed in an unlicensed facility and that product testing had obscured severe side effects. As the case attempted to discern whether or not the devices’ testing had been fraudulent, a biomedical engineering expert familiar with Essure was asked to review the records and device, commenting on their findings.

Question(s) For Expert Witness

  • 1. Please briefly describe your experience working with sterilization devices, specifically Essure.
  • 2. Are you familiar with the potential complications of these IUD devices?
  • 3. Are you able to review the available records and the product in question and opine on your findings from a biomedical engineering perspective?

Expert Witness Response E-010885

I have worked on electrosurcial products used in a hysterectomy procedure. I was retained and deposed in the Mirena MDL cases. I am familiar with claims of migration. The complications listed with the device include: Unintended pregnancy, including ectopic pregnancy, pelvic pain, migration of Essure inserts through the fallopian tubes into the lower abdomen and pelvis, perforation of the uterus or fallopian tubes, Rash and itching associated with possible nickel allergy. The Manufacturer And User Device Experience database includes 503 reported adverse events, which I have on file.

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