Could it be that the U.S. Food and Drug Administration greatly underestimated the rate of fetal deaths among women who became pregnant after they used a contraceptive device from Bayer?
Madris Tomes, founder and CEO of Device Events, thought so. The private analyst combed through FDA's public database, which said there are five fetal deaths in women who turned pregnant after the use of Essure, a two-metal coil product inserted into the fallopian tubes to block pregnancy.
Surfacing in Tomes’ analysis are actually 303 fetal deaths linked to the contraceptive.
“My system searches the (fuller) narrative,” said Tomes in an interview, pertaining to her keywords like “stillbirth,” “fetal death” and “miscarriage” instead of broad headings such as “death,” “injury” or "malfunction" used in FDA’s probe of adverse events.
Tomes said she was an FDA consultant or data analyst employee for four years before she set up her own firm last summer to analyze the regulatory agency’s public data.
Tagged as an alternative to tubal ligation, Essure was approved in 2002, and since then the FDA has received thousands of complaints revolving around the breakage, movement or injury caused by the device. Dozens who attended an FDA meeting back in September called for the withdrawal of the product, raising uncertainty around its safety.
Pennsylvania representative Mike Fitzpatrick, who has earlier filed a bill for Essure’s removal in the market, sent the FDA a copy of Tomes’s report and urged for a review of the “immense discrepancy” in figures. He has also called the agency to pull its prior approval.
“Women [and] citizens are being harmed,” said Fitzpatrick, who claimed that the FDA did not sufficiently attended to complaints against Essure.
“If you actually read the narratives of those reports that have been filed, those complaints, the number exceeds 300,” added the Republican representative.
Tamara Monroe, a Levittown resident, said in an NBC10 interview that she had problems using Essure, including “a lot of” fatigue, weight gain, brain fog, heavy bleeding and “very bad” abdominal pain.
Several physicians vouched for Essure at a recent FDA hearing, while Bayer HealthCare said in a statement sent to NBC10 that it is “irresponsible” to suggest that its product causes fetal deaths when an unwanted pregnancy cannot be carried to term in the event of an unsuccessful Essure procedure.
“The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure was first developed,” part of its statement read.
The FDA will decide later this month on the use of Essure on the market, if the product label will be changed or further clinical trials will be recommended.
