FDA Admits Mislabeling Essure Safety Data Amid Investigation Revelation

FDA Admits Mislabeling Essure Safety Data

Was it an innocent computer glitch, or an intentional concealment of problems and complaints involving the Essure permanent birth control device? That’s the question being asked following the FDA revelation of hundreds of errors in the Essure safety reporting data.

Bayer AG manufactures Essure and markets it to women as a safe, non-surgical permanent birth control method, which can be done in a doctor’s office in 15 minutes, with no anesthesia, little downtime, and at a fraction of the cost of a tubal ligation. A metal coil, about the size of a spring in a ballpoint pen, is placed in each fallopian tube and scar tissue grows around the coils, thereby preventing pregnancy. Since its market approval in 2002, thousands of women have reported a variety of problems after having the Essure implant including, but not limited to, excessive bleeding, abdominal pain, back pain, perforated organs by coils, coil movement and breakage, pregnancy, increased risk of ectopic pregnancy, depression, chronic fatigue, bloating, weight gain, and allergic reactions to nickel in the device.

The FDA relies on doctors and patients to report problems with medical devices, and tracks the safety and effectiveness of approved medical devices like Essure through Adverse Event Reports, or ADRs. Patients or doctors can report problems, and the data report identifies the occupation of the reporter, whether the reporter is a patient or a doctor. The FDA relies on these ADRs in evaluating the safety and effectiveness of medical devices, giving greater weight to doctors’ ADRs because of their medical background, expertise and training.

The FDA now admits doctors’ ADR’s have been mislabeled since August 2015, including over 300 adverse event reports about Essure, where the data fields misidentified the reporter as “other” instead of “physician”. The FDA claims it is an innocent mistake due to a computer glitch when internal coding practices changed in July 2015, but many are speculating whether it is purposeful concealment given the timing of the alleged “glitch”.

One strong women’s proponent regarding the Essure device, Rep. Michael Fitzpatrick (R-Pa.), found the timing particularly disturbing given that the FDA had just announced July 17, 2015 it was reviewing the safety and effectiveness data of the Essure birth control device to determine whether it should remain on the market, or be removed until new safety studies are conducted. Since the FDA’s admission on the data reporting errors, the accuracy of the safety data comes into question. If the safety data is skewed, or incorrectly recorded, the safety studies will not accurately portray the problems suffered by women with the Essure implant, and a potentially dangerous product will remain on the market capable of injuring more women to whom the device is being recommended as a “safe”, non-surgical alternative to tubal ligation.

The FDA’s revelation of hundreds of data reporting errors comes after long-awaited action on Essure when the FDA on February 29, 2016, recommended only a new black-box warning on Essure packaging, for additional clinical safety tests to be conducted by Bayer AG, and a Patient Disclosure Form, instead of removing the device from the market as many were hoping.

Rep. Fitzpatrick has called for Congressional hearings on the Essure implant and asked the FDA to withdraw approval of Essure until an internal FDA investigation is conducted, and has presented a bill to Congress to stop the sale and implantation of the Essure device until further safety tests are completed.