Despite reports of Essure side effects and a wave of products liability litigation, the FDA has still declined to take Essure off the market.

Essure is an implantable birth control device designed to be an alternative to traditional surgical sterilization for women seeking permanent contraception.

It consists of a pair of metal and polyester coils that are placed inside a woman’s fallopian tubes, where they stimulate the growth of new tissue.

Essure is designed to be implanted in a brief procedure in a doctor’s office, without incisions or general anesthesia. If all goes as planned, the new tissue prevents fertilization.

However, many women have reported Essure adverse effects severe enough to raise the question of whether the device should be on the market at all.

FDA Looks Into Essure Adverse Effects

Over a year ago, a group of women offered testimony in a Food and Drug Administration hearing about their own experiences of Essure adverse effects.

One of those women, Kim M., said that after she was implanted with Essure, she developed severe abdominal pain. The pain was bad enough to force her to quit racing horses.

Her doctor discovered that her Essure implants had punctured her fallopian tubes, so Kim had both implants surgically removed. But even then, the pain did not stop.

It wasn’t until three years later, when Kim had a hysterectomy, that the pain finally subsided. Doctors then discovered that even after having her Essure implants removed three years before, Kim still had a piece of a metal coil stuck in her uterus.

Bayer, Essure’s manufacturer, maintains it isn’t to blame for Essure adverse effects. The company claims problems like Kim’s can be traced to inadequate surgical skills on the part of the doctors who implant Essure.

Bayer also claims there is no scientific evidence showing Essure could be the cause of other reported problems like autoimmune reactions and chronic pain.

FDA representatives say that although some women have experienced considerable complications from Essure, it is still considered safe and effective for many others.

Instead, the FDA required a new black box warning be added to the informational materials distributed with Essure. The new warning alerts patients and doctors to the reports of Essure adverse effects like puncturing the fallopian tubes and migration through the pelvic cavity, potentially causing chronic pain.

The FDA also required Essure to be accompanied by a doctor-patient checklist. The checklist is designed to be reviewed by potential Essure patients in consultation with their doctors, hopefully to give them a better picture of the risks associated with Essure.

Review of the checklist is not mandatory, however. Critics also point out that the checklist doesn’t mention many other reported Essure complications, such as abnormal menstrual bleeding.

Others point out that both the checklist and the black box warning are based on anecdotal reports, not rigorous clinical studies.

A new study by Bayer could provide some of the information these critics are calling for. Begun earlier this year, it will track 1,400 women implanted with Essure over the next five to six years and compare their experiences with those of 1,400 other women who ungergo sterilization via laparoscopic surgery.

The study’s results are not due until 2023, however, and it is already reported to be behind schedule.