The United States Food and Drug Administration might have underestimated by a large amount the number of fetal deaths amongst women who used the contraceptive device Essure but became pregnant, according to one analyst.
The FDA has stated there were five fetal deaths from the women who used Essure and became pregnant. Essure is made up of two metal coils that are inserted inside the fallopian tubes.
CEO and founder of Device Events, Madris Tomes said the analysis she did of thousands of adverse events on the agency’s website shows more than 300 fetal deaths that are linked to Essure.
The agency this month is expected to decide if the device should be restricted, change the label on the product or to recommend trials that are more clinical.
The U.S. regulatory agency also cited four deaths by adults for reason like uterine perforation and infection.
The wide disparity among fetal deaths between her own analysis and the FDA was due the agency searches have broader headings of the adverse events that the agency receives from doctors and patients rather than the searching of detailed texts related to such complaints, said Tomes.
When the FDA receives an adverse event the boxes that get checked are death, injury or malfunction, said Tomes. She said her system searches a fuller narrative such as fetal death, stillborn, stillbirth and miscarriage.
Tomes was a data analyst employee or consultant to the FDA for a period of four years prior to opening her own business this past summer to analyze the public data of the agency
Mike Fitzpatrick a Representative in the U.S. House from Pennsylvania, who introduced legislation to remove Essure from the U.S. market, Wednesday sent a copy to the FDA of the report by Tomes and urged the regulatory agency to review the massive discrepancy.
A spokesperson for the FDA declined to make a comment on Wednesday about the analysis done by Tomes, but did say the FDA would be reviewing it and would be responding to the U.S. Congressman.