The FDA has agreed to investigate Bayer's Essure birth control device, following complaints of fraud during the clinical trial and dangerous side effects.
In a letter posted on Regulations.Gov, Dr. William Maisel, chief scientist of the FDA's device arm (CDRH), wrote that "the Office of Compliance will pursue actions as deemed necessary" in a response to a citizen petition. "However, CDRH does not provide information during the investigation, nor does it provide explanations of the outcome of the investigation to the correspondent who made the complaint," he continued.
The petitioners, Marcus Susen and Justin Parafinczuk, "requested that the commissioner issue orders relating to disclosures and findings, variously modify premarket approval (PMA) terms, and initiate a recall," based on allegations that "the product sponsor perpetrated fraud with respect to clinical trials; the sponsor violated the terms of the PMA; and federal laws were violated," according to Maisel's letter.
According to MD+DI, the petitioners complained to the FDA on behalf of hundreds of women who say that the device caused adverse events like like device migration and organ perforation.
Bayer purchased the device through its acquisition of Conceptus in 2013. MD+DI says Essure is placed hysteroscopically and blocks the fallopian tubes to achieve permanent birth control.
- read the letter
- here's MD+DI's take
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