Even though the FDA has ordered a post marketing surveillance study of the Essure birth control product, the medical community and general public may have to wait years for the Essure study results.

The FDA had ordered Bayer HealthCare to conduct the study, after thousands of women reported suffering complications from the Essure birth control.

The Essure birth control consists of two metal coils, each of which are inserted into each fallopian tube.

The tissue eventually swells around the coils, ultimately blocking sperm to egg fertilization.

As a purportedly safe and convenient alternative to tubal ligation, thousands of women have opted for the Essure birth control device.

However, just as many women have allegedly suffered serious injuries in result of using the permanent contraceptive.

According to 8News, the Essure study results could take another seven years to produce since the FDA’s approval of the post market surveillance study.

The final report is not due until 2023, with consumer advocates and even certain members of Congress excited for the Essure study results.

Pennsylvania congressman Mike Fitzpatrick is asking requesting a safety hearing for medical devices like the Essure from the rest of Congress, in cases of “the failings of the U.S. Food and Drug Administration.”

Overview of Essure Birth Control Complications Concern

There have been four deaths officially, with 8News discovering the FDA had received 10,000 serious complications reports.

Even though there have been numerous Essure birth control injuries reported, the FDA has not recalled the device from the market.

Instead, the agency required Bayer Healthcare to add a black box warning to the birth control device.

The FDA had also called for the company to conduct the post marketing study, with the expectation of the Essure study results yielding accurate safety profile results.

However Fitzpatrick is worried numerous other women will be harmed in the meantime, stating that the safety issues of the device are to great to wait on the Essure study results.

“Congress cannot ignore the voices of those harmed by unsafe medical devices. We must allow them to tell their stories, present their innovative policy solutions, and help us bring our medical device safety laws into the 21st century,” Fitzpatrick’s letter to the Committee on Energy and Commerce stated.

Six other members of Congress have signed the letter, with Fitzpatrick’s office waiting to hear a reply.

Fitzpatrick’s concern is well justified, as hundreds of thousands of women opt for the permanent birth control product.

The Essure birth control is the only permanent non surgical female sterilization method available in the United States.

Even though Essure birth control complications pose very serious problems, Bayer HealthCare allegedly omitted the complications from the device’s warning label.

Numerous women have filed legal action against Bayer HealthCare, seeking various product liability damages. Potential claimants can contact a specialized lawyer to determine eligibility for an Essure lawsuit.