FDA underestimated number of fetal deaths linked to Bayer’s contraceptive
Feb 23, 2016 12:54 AM EST
The U.S. Food and Drug Administration may have underestimated the number of fetal deaths among women who became pregnant after they used Bayer's Essure contraceptive device.
The FDA in the past has said there are five fetal deaths in women who turned pregnant after using Essure, a two metal coil inserted into the fallopian tubes to block pregnancy.
But a private analyst who combed through FDA's public database has claimed that the number of fetal deaths related to the contraceptive device is much higher. An analysis report from Device Event, a data analysis company, has suggested that there are at least 303 fetals deaths related to the using of Essure, FiercePharma reports.
Madris Tomes, founder and CEO of Device Event, said in an interview that the company's system searches the fuller narrative. Tomes, who is a former FDA consultant and data analysis employee, said her analysis pertrained keywords like "stillbirth", "fetal death" and "miscarriage" instead of broad headings used in FDA's probe of adverse events, such as "death", "injury" or "malfunction", according to TechTimes.
The FDA has received thousands of complaints from women who used Essure, including the breakage, movement or injury caused by the implant. The agency also cited four adult deaths related to the product, caused by infection and uterine perforation.
At the FDA meeting in September, dozens of women called for the withdrawal of the product, which was approved by the FDA in 2002.
State representative Mike Fitzpatrick, a Pennsylvania Republican, has filed a bill for the removal of Essure from the market. Fitzpatrick urged the agency to pull its prior approval. He sent the FDA a copy of Tomes' report and urged for a review in the issue.
The FDA spokeswoman Deborah Kotz said the agency would respond to Fitzpatrick and would review Tomes' analysis.
According to Reuters, a spokeswoman for Bayer said that it would be irresponsible to suggest that Essure causes fetal deaths. She added that there can be complications when pregnancies occur during contraception use, regardless the type of birth control a woman uses.
Bayer maintains that Essure is safe and effective. The company said about 750,000 units of the contraceptive device have been sold, mostly in the U.S.
The healthcare company said that the safety and efficacy of Essure is supported by more than a decade of science and real world clinical experience. Bayer stated that the product was studied with more than 10,000 women since its first development.
The FDA is expected this month to decide whether to restrict use of Bayer's Essure. The agency will decide if the product label will be changed or additional clinical trials will be recommended.