Bayer responds to article critical of its Essure birth control device under FDA investigation

Bayer responded to an article in The New York Times critical of the company's Essure contraceptive inserts with a letter to the editor that claims the story "mischaracterizes" a recently published long-term study of the device.

The device, which is placed hysteroscopically and blocks the fallopian tubes to achieve permanent birth control, is under investigation by the FDA.

The German pharmaceutical giant said the study, which was recently published in the Journal of Minimally Invasive Gynecology, "reinforces the safety and efficacy of the device and the procedure." The side effects reported in the study are consistent with other studies and its instructions for using Essure that "the FDA approved in 2002 and then reevaluated in 2013," according to a Bayer press release.

In the story published a week ago, the newspaper said only 366 of an original 518 participants were followed for the full 5 years of the study. Of those women who were tracked for the full timeframe of the study, 15 had hysterectomies, of which two of the procedures might "possibly" be related to Essure. Thirty-eight percent of the same group of women experienced unusually heavy periods on a recurring basis. One in 20 patients had recurrent pelvic pain, and one in 15 had recurrent painful periods.

Last month, the FDA announced it would investigate the Essure birth control device, following complaints of fraud during the clinical trial and claims of dangerous side effects. According to a petition filed with the regulatory agency on behalf of hundreds of women, the device caused adverse events like device migration and organ perforation.

Bayer purchased the device through its $1.1 billion acquisition of Conceptus in 2013.

- check out the Bayer release
- see the Times' story