A Congressman is making a bold accusation against the regulatory agency on the birth control device Essure.
A U.S. Congressman is rolling up his sleaves and coming after the Food & Drug Administration hard over birth control device Essure.
Rep. Mike Fitzpatrick (R-Pa.) is accusing the FDA of drastically understating the fetal deaths called by controversial birth control device Essure, according to a WXYZ report.
The FDA says only five deaths have been related to Essure, but Fitzpatrick claims that an independent report reveals the true number to be 303. In a letter to the FDA, he demand that the agency conduct an investigation into whether Essure should be yanked from the market.
Essure is used instead of tubal ligation as a sterilization procedure. It induces fibrosis to block the fallopian tubes and prevent fertilization. It was first approved back in 2002.
Essure has come under scrutiny in recent months, as several woman testified at an FDA panel in September that Essure was dangerous. The FDA is reviewing Essure, and the final results are expected later this month.
Fitzpatrick also said that he had gotten a hold of an unsealed complaint originating from a federal lawsuit filed against Bayer Healthcare, the owner of the company that created Essure. The congressman said the complaint claims there were illegal kickbacks in the form of $20,000 worth of free medical equipment. He also claimed that 25,000 women had come down with severe symptoms from the device, and has also introduced legislation that would force the FDA to remove Essure from the market.
Bayer vehemently denied the allegations, claiming that it was untrue that an investigation revealed unreported deaths, and that Bayer had complied with FDA regulations in reporting adverse events. In a statement, Bayer said that Essure was a highly effective method of birth control and that as with any medical treatment, there can be complications that arise from using it.
Bayer also rejected the notion that there were kickbacks, stating that the allegations were made more than a year ago and had been thoroughly investigated by the Department of Justice.