An analyst is claiming that the number of fetal deaths related to a contraceptive device was greatly underestimated by the FDA, Reuters is reporting.
The FDA says five fetal deaths have been linked to women who became pregnant after using Bayer AG's Essure contraceptive device, but Madris Tomes, says the number is closer to 303, according to the report.
Essure is a medical device that is permanently placed into a woman's fallopian tubes by a doctor to form a natural barrier to prevent pregnancy. The FDA is "expected this month to decide whether to restrict use of the device, change the product's label or recommend additional clinical trials," Reuters reported.
Tomes, founder and chief executive officer of Device Event, alleges that 303 fetal deaths were linked to Essure after reviewing adverse events on the FDA's website.
A spokeswoman for Bayer called the allegations "irresponsible."
"Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications," she told Reuters. "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."
The FDA also reported four adult deaths because of infections and uterine perforation, Reuters reported.