Bayer, Karl Storz, Announce New Essure Training Programs For Gynecologists

In the face of growing concerns over complications with Essure birth control implant, Bayer has announced a new educational program designed to train gynecologists on the safe and proper methods for implanting the device. 

In a press release issued on November 3, Bayer Healthcare indicated that it is launching a collaborative effort with medical device manufacturer Karl Storz Endoscopy-America, Inc. to provide training regarding Essure birth control.

The training will include videos and comprehensive platforms for OB/GYN residency programs at teaching hospitals across the United States, Bayer indicates.

The announcement comes amid continuing reports involving women who have experienced severe and debilitating problems from Essure implants, including extreme abdominal pain, excessive bleeding and internal organ injuries.

The birth control implant is offered as an outpatient procedure by many medical facilities. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

Although the procedure has become increasingly popular, the FDA has received hundreds of adverse event reports over the past year involving side effects of Essure birth control, including instances where women had to undergo a hysterectomy due to complications that may have been experienced.

Concerns over the birth control implant gained substantial media attention over the summer, following Congressional testimony involving an Essure injury during a briefing by the National Center for Health Research that called for legislation to improve the FDA approval process.

Bayer, which bought the original company that designed the Essure implant and now markets the device worldwide, has downplayed the complaints, maintaining that there are relatively few cases out of the Essure implants used worldwide.

“This collaboration of two leading healthcare companies offers great potential for enhancing physician support with regard to these procedures,” Paul Bedard, Bayer’s senior vice president and general manager of women’s health, said in the press release. “For gynecologists, this will mean a solid foundation for extending the important services they can offer. And, their patients benefit from having access to an important permanent birth control option.”

The new training programs and use of specially crafted medical devices by Karl Storz will help make Essure implantation safer, according to Bayer. However, it does not appear to address concerns raised by patients in recent months.