Bayer Healthcare wasted no time fighting claims made by a U.S. Congressman that the company’s controversial birth control device Essure was linked to 303 fetal deaths.
“Ectopic pregnancies and blighted ovum are not considered fetal deaths and can occur for a multitude of reasons not related to Essure,” Bayer said in a statement. “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.”
Essure is the only non-surgical permanent birth control method on the market. It consists of two coils that are inserted into the fallopian tubes where they are designed to build up a scar tissue barrier that prevents the sperm from reaching the egg.
Rep. Mike Fitzgerald, R-PA, spearheaded a campaign last year to ban the device after nearly 10,000 reports of adverse events ranging from allergic reactions, infections, chronic pain, device migration, perforation of the fallopian tubes or vaginal wall, and embedment in tissue and organs.
An investigation by a third-party researcher found that Essure had been linked to 303 fetal deaths – a far cry from the five the Food and Drug Administration (FDA) claimed to have in its records.
The researcher, Madris Tomes, founder and CEO for Device Events, said the disparity in the two numbers was because the FDA searches broad headings of adverse event reports rather than searching detailed texts within the complaints. For example, Tomes said instead of just focusing on “death,” “injury” or “malfunction” reports, she looked for keywords such as “fetal death,” “stillbirth” and “miscarriage.”
Tomes also found that Essure had been linked to at least five adult deaths, which were attributed to infection and uterine perforation.
The FDA is currently conducting a safety review to determine whether new warnings should be placed on the device. The agency is expected to give its recommendations later this month.
Source: PIX 11