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April 27, 2015
2 Min Read
Several women treated with the Essure device have died although the manufacturer insists that the product is safe.
The Essure permanent birth control device from Bayer Healthcare (Leverkusen, Germany) has won considerable negative attention in recent memory. FDA is launching an investigation into the device after five women died after being treated with it. To date, more than 4500 adverse events related to the device have been filed with the agency.
The Law Offices of Koch Parafinczuk & Wolf, PA filed a petition with FDA that convinced the agency to launch the investigation into the device, which is marketed as an alternative to tubal ligation. The petition asks the FDA commissioner to acknowledge that the PMA that granted for the device "has been violated," explaining that the clinical study mentioned in the PMA application was "replete with fraud." The petition claims that patients involved had their answers on clinical trial paperwork crossed out by applicants to downplay the incidence of pain and adverse events associated with the device. It points to the sworn testimony of the clinical trial participants to support this claim.
In 2013, famed consumer advocate Erin Brokovich launched an online campaign to have the device removed from the market. Brokovich maintains that the device is not an effective birth control method, despite its manufacturer's claim that it is 99% effective. She also states that the device is unsafe. She launched a petition to have the device pulled from the market, which has attracted nearly 13,000 signatures to date.
Roughly 750,000 women have been treated with the device.
Earlier this month, Bayer responded to sister publication MD+DI by stating, in part, that it "stands behind the safety and efficacy of Essure and will aggressively defend itself in Court. FDA has closed the petition and forwarded it to the Office of Compliance. We are cooperating with the FDA, and we will respond to any questions that the agency may have related to the allegations."
Complaints claiming that the device is unsafe state the the metal coils of the device can occasionally come dislodged from the fallopian tubes, cutting other organs.
After the most recent death associated with the device, Bayer stated: "Death is not a known failure mode related to Essure."
Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.
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