The FDA has recently signed off on Bayer’s proposed plan for its updated post-market surveillance study to take a closer look at its permanent birth control device, Essure.

The Essure study was mandated by the FDA in February following reports of four adult deaths, 15 reports of pregnancy loss and an additional 631 reports of patients who still got pregnant using the permanent birth control device.

In addition to requiring Bayer to conduct the post-market surveillance study, it also required the manufacturer to add a boxed warning to the Essure device.

The FDA has said that since Essure device was approved in November 2002 up through the end of last year, the agency received nearly 10,000 medical device reports related to the Essure birth control device.

The FDA reports regarding Essure problems and complications include the following as the most commonly reported:

• Pain in the abdominal area and elsewhere
• Heavier menstrual periods and menstrual irregularities
• Headache
• Fatigue
• Fluctuations in weight
• Device incompatibility/nickel allergy
• Migration of the Essure device
• Device performed differently than anticipated
• Breakage of device
• Difficulty removing device
• Device malposition
• Difficulty inserting device

Additional complications have also been reported with the Essure device including pregnancy, ectopic pregnancy, stillbirth, pain with intercourse, hormonal irregularities and more.

An Essure study published in the BMJ last year indicated that women who were implanted with the Essure device for sterilization were more likely to have another operation as compared to women who initially opted for tubal ligation.

A Congressional bill is currently in the works initiated by Rep. Mike Fitzpatrick (R-PA) with the intent of seeking to revoke FDA approval for the device, saying it is “unbelievable that it took the FDA since September to make just to recommendations with no enforcement measures and asked the manufacturer to perform another study while leaving Essure on the market… If the FDA is going to order another study, that at minimum they should take Essure off the market during that time.”

Another representative, Rep. Rosa DeLauro (De-CT), asked the FDA in October 2015 to remove Essure from the market.

Bayer Essure Study

The Essure study that will be conducted by Bayer now that the FDA has approved the plan will be an observational study that will examine two groups of 1400 women between the ages of 21 and 45.

These women are required to not have been pregnant in the prior six weeks. One group of women will have Essure implanted and the other group of women will undergo laparoscopic tubal sterilization.

A six-month report will be released in March 2017 and a one-year report will be released in September 2017. However, the final report will not be ready until 2023.

The Essure study will focus on specific symptoms to look at more closely – those include chronic pain in the abdomen or pelvic region, allergic reactions to the components in the medical device, abnormal bleeding and how surgical removal of Essure fares.

Other secondary safety considerations that will be examined include additional information provided by patient blood work, pathology, histology and testing for metals. The effectiveness of the device will be measured by its ability to prevent pregnancies.