FDA Panel Questions Safety of Essure Birth Control as Lawsuits Loom

In April, DrugNews reported on an FDA report that noted an increasing number of reported side effects among women fitted with the permanent birth control device Essure.

Last week, a panel of independent doctors questioned both the maker of the device, Bayer, and the FDA, on why and how the device was approved for use and why side effects have spiked. They also laid out a plan for further testing to determine the risk to patients.

The news comes as a federal judge is set to decide if thousands of potential Essure lawsuits from those injured can move forward.

Designed to be Safe and Permanent

Essure is a thin metal coil that is surgically inserted into a woman’s fallopian tubes to provide permanent sterilization. It is considered an alternative to more invasive procedures like tubal ligation.

The device was developed by California-based medical supply company Conceptus and approved by the FDA in 2002. However, it was then purchased by Bayer in 2013.

Essure Side Effects Spike in Last Few Years

Initially, the percentage of women experiencing problems with Essure appeared very low. Despite more than 750,000 devices implanted worldwide, only 115 complaints were submitted to the FDA as late as 2011. Since then, however, the rate of complications has grown 20-fold.

Last year, the FDA received 2,259 reports of complications among Essure users. In only the first 5 months of 2015, they’ve received 1,363 complaints. So far, more than 5,000 women have reported serious side effects. And, since the FDA adverse event reporting system is voluntary among patients, some experts estimate it only measures 25% of the true problem.

Numerous Essure Side Effects Reported

The reported side effects of Essure range from pelvic and abdominal pain to fatigue, depression and hair loss. These could be a sign of serious metallic allergic reactions to the nickel used in the product.

And while the FDA reviewed clinical trial results from approximately 600 women before approving the device, many have come forward claiming that doctors conducting the study ignored their complaints of pain.

Conflicting Essure Study Data

Also, a recent review in the Journal of Minimally Invasive Gynecology found that only 366 of the original clinical trial subjects were recorded for the entire 5-year period.

The FDA previously asked Bayer to conduct more testing on Essure. In May, the company claimed that only 7% of patients experienced pain.

This conflicts with data from the National Center for Health Research, which, in a study of over 1,000 women, found that 86% experienced significant pelvic or abdominal pain.

The panel of doctors at last week’s hearing didn’t take a vote or make formal recommendations for the FDA. However, many questioned why the agency hadn’t required more stringent testing of the device prior to approval, such as a randomized clinical trial. Some called for new and independent testing to take place now.

Essure Lawsuits Await Decision of Federal Judge

At the same time, a growing number of women injured by Essure devices have filed lawsuits against Bayer, claiming they were misled as to the complications. Normally, the Medical Device Regulation Act would forbid lawsuits against products approved by the FDA. However, plaintiffs have challenged whether the misleading data submitted for approval renders this loophole not applicable in this case.

Lawyers are currently awaiting the decision of a federal judge about whether Essure lawsuits can proceed. If they are allowed, it is expected that thousands will eventually come forward to seek compensation from Bayer.

DrugNews will continue to chart the research, side effects and litigation surrounding Essure birth control devices.

Sources:

Wasserman, E. FDA: Bayer's Essure device linked to increase in side effect reports. Fierce Medical Devices. (September 22, 2015). Retrieved from www.fiercemedicaldevices.com

Burton, T. Medical Panel Calls for Further Study of Bayer Sterility Device. The Wall Street Journal. (September 24, 2015). Retrieved from www.wsj.com