The FDA may have greatly underestimated the number of fetal deaths among women who became pregnant after using the contraceptive device Essure (Bayer), according to a Reuters report. The device consists of two metal coils inserted into the fallopian tubes. Approved in 2002, Essure was marketed as an alternative to tubal ligation. The FDA has since received thousands of complaints, including reports of the device breaking or moving and causing injuries.
Madris Tomes, founder and chief executive officer of Device Events, combed through thousands of adverse events on the agency’s public database and found that 303 fetal deaths were linked to Essure. The FDA has cited only five fetal deaths in women who became pregnant after using the device.
Tomes worked for the FDA as a consultant or data analyst for four years before setting up her own company last summer to analyze the agency's public data.
This month, the FDA is expected to decide whether to restrict use of the Essure device, change the product’s label, or recommend additional clinical trials. The agency also cited four adult deaths due to infection, uterine perforation, and other causes.
Bayer maintains that Essure is safe and effective.
“Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications,” a spokeswoman for the company said. “It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term.”
In September 2015, dozens of women who attended an FDA advisory meeting urged the agency to withdraw the Essure device, saying that not enough is known about its potential to harm users.
Source: Reuters; February 17, 2016.