Since it hit the market, doctors have reported hundreds of problems with Essure birth control.  Yet, these adverse event reports may not have been recorded properly by the FDA, causing inconsistencies in the safety data.

According to former Food and Drug Administration analyst Madris Tomes, medical professionals have reported over 300 Essure problems since August 2015. Yet, these adverse side effects were not recorded by the Agency.

The FDA has blamed the error on a computer glitch. FDA spokeswoman Deborah Kotz, says the FDA became aware of the error during an upgrade to the adverse event reporting database in August 2015.

Kotz stated that the glitch affected the ‘reporter occupation’ field in the database, and resulted in the database not properly registering if the person filing was a doctor or nurse.

Kotz has stated that the FDA has taken full responsibility, and Bayer is not responsible for this error in any way. Previously, Kotz had sent ABC7 News Investigation Unit (I-Team) an email indicating the FDA made no mistake and that they simply enter the code provided by Bayer Healthcare.

However, the FDA has confirmed Bayer had reported the cases correctly, and the coding error should be resolved soon. The FDA stated the coding error resulted in the mislabeling of other side effects associated with other medical devices, but did not impact how regulators analyze the safety of the products.

However former Essure birth control patient, Elena M. states that it was important to know whether or not a nurse or doctor reports a problem because analysts may take it more seriously from a practicing physician.

Soon after Elena had the Essure birth control implanted, the coils had punctured her endometrial cavity and eventually had to have the coils removed.

Overview of Essure Side Effects

The Essure birth control was approved by the FDA in 2002, and was originally manufactured by Conceptus Inc. Now manufactured and marketed by Bayer, it has earned the company millions and has been implanted in approximately 750,000 women.

The Essure birth control consists of two flexible metal coils made of metal and polyethylene fibers, and is directly inserted directly into the fallopian tubes. After a few months, the tissue of the fallopian tubes begins to swell around the coils and eventually blocks conception.

The Essure birth control is currently the only non surgical method of sterilization for women, with it being marketed as safer and more convenient than tubal ligation.

When the Essure birth control was approved, it had been approved on the FDA’s fast track review system as it provided a non invasive alternative to traditional tubal ligation.

A number of women of reported suffering Essure problems, with many complaining the product was not properly evaluated before being released into the market.

Essure side effects reported from women include: bloating, rashes, allergic reactions, bleeding, organ perforation, pelvic pain, miscarriage, and ectopic pregnancy. Ever since its approval, 4,500 Essure side effects have been reported to the FDA.

A number of former Essure birth control patients have filed legal action against Bayer, alleging the company failed to protect them against Essure problems. Potential claimants should contact a specialized lawyer, to determine if they have an Essure birth control lawsuit.