Essure Failure and Removal – What Are The Options? | Levin Papantonio | Personal Injury Lawyers

Essure Failure and Removal – What Are The Options?

The Essure contraceptive device is associated with numerous complications. These include severe cramps, painful intercourse, sudden and unexplained weight gain, and excessive bleeding, along with allergic reactions caused by the nickel titanium alloy used in the manufacturing process.

Not every woman who has this device implanted will experience these complications. However, for those women who are affected, options are few – and physicians are not in complete agreement as to how to correct these problems when they arise.

A study published in the British Medical Journal in 2015 followed more than 52,000 women in New York over an eight-year period, comparing those who had been implanted with the Essure device with those who had undergone a standard laparoscopic tubal ligation.

The researchers concluded that while both methods of permanent contraception were equally effective at preventing pregnancy, those who had Essure wound up with significantly higher expenses. Furthermore, despite manufacturer Bayer's claim that Essure is a simple outpatient procedure that can be performed within ten minutes, over 50% of those patients wound up needing anesthesia.

That wasn't the worst of it. They also found that women with Essure were ten times more likely to require follow-up surgeries than those who had a tubal ligation.

One of the problems is that the Essure implant was designed to be permanent. Furthermore, when doctors have recommended Essure and patients have chosen to get the implant, they may not have known all the facts. This is not surprising. The FDA granted pre-market approval for Essure in 2002.

This approval was contingent on the original manufacturer (Conceptus, now owned by Bayer AG) doing two future clinical studies. These were not carried out, and over the years, the manufacturer received over 30,000 adverse event reports. Despite this, no warnings were issued by the manufacturer. The FDA finally issued its own advisory and began requiring a “black box” warning on Essure packaging in February 2016.

Not surprisingly, not many doctors have the knowledge and skills to remove Essure devices. Most of those who do treat complications associated with Essure wind up relying on hysterectomies.

Although a hysterectomy is a major surgery with more potential complications and a longer recovery period for the patient, it may be the best option for women who are experiencing the negative side effects of Essure. One reason is that most gynecologists are trained in this procedure. Another reason is that a hysterectomy is more likely to be covered by an insurer. Finally, other methods of removal usually require several surgeries, particularly if the device fractures or migrates, whereas a hysterectomy is a one-time procedure.

The good news is that many women who experience symptoms associated with Essure begin to experience relief about fourteen days following removal of the device.