Report Claims FDA most likely Underestimated Number of Fetal Deaths from Essure
A new report from a private analyst is claiming that the Food and Drug Administration (FDA) most likely underestimated the number of fetal deaths that occurred after pregnant women used Bayer AG's Essure contraceptive product.
According to the FDA, there have been a total of five fetal deaths in women who got pregnant after using Essure, which is a permanent form of birth control that involves inserting two metal coils into the fallopian tubes. Analyst Madris Tomes, the founder and chief executive officer of Device Events, is claiming, however, that a total of 303 fetal deaths could be tied to Essure.
Tomes explained that her analysis resulted in a higher number of cases because the search that she conducted was a lot more detailed than the agency's.
"When adverse events go to the FDA, 'death', 'injury' or 'malfunction' are the boxes you check," Tomes said, reported by Reuters. "My system searches the (fuller) narrative."
Tomas said she used additional keywords, which included fetal death, stillbirth, stillborn and miscarriage.
Bayer commented about the link between Essure and fetal deaths, stating that although complications can occur, Essure does not cause fetal deaths. Bayer added that about 750,000 units of Essure have been sold since it was approved in 2002.
"Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications," the company's spokeswoman 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."
The FDA will be deciding on what to do next with Essure. The agency could restrict the use of the birth control, mandate the company to change the label or recommend more clinical trials. The agency has also cited four adult deaths tied to Essure.
The FDA stated that it would review Tomes' analysis.