Essure Not a Sure Thing

For people with a uterus who want permanent contraception, Essure seemed to offer many benefits. The device, which is put into the Fallopian tubes to create scar tissue and prevent pregnancy, can be placed at a doctor’s office without anesthesia or a hospital stay. Unfortunately, the device’s popularity was held back by horror stories about side effects. Now, a new study confirms that patients with Essure are more likely to need an reoperation compared to those who chose to have their tubes tied with surgery.

A few good benefits and some major risks.

The study used data from over 50,000 patients treated in New York state between 2005 and 2013. Of these, only 8,000 had Essure placed. In addition to avoiding anesthesia and the hospital, those with Essure also had a lower risk of major medical complications 30 days after it was placed. The risk of unintended pregnancy is the same for both permanent options.

Unfortunately that’s where the good news ends. Essure is an average of $2000 more expensive. And patients with it were 10 times more likely to need a reoperation later on compared to those who had surgery. This difference held steady even after adjusting for age and other health problems.

An outcome patients care about.

The study is the first to look at Essure’s safety as it relates to the need to undergo surgery. Though the study did not examine reasons behind patients’ choices, we can speculate that many wanted to avoid surgery for either personal reasons or medical one such as obesity or scarring from previous abdominal operations.

Like all research, this one has its flaws.

The overall rates for reoperation are still pretty low at 2% compared to surgical sterilization’s 0.2%. Additionally, because the study used medical record data, we don’t know the purpose of the reoperations. Were they for a serious problem or second attempts to place the device? Lastly, Essure patients are supposed to come in for a three-month follow-up, unlike those who get their tubes tied. This means that it’s easier to discover problems since a surgical patient may not see their doctor again until their next annual visit or if a problem arises.

Nevertheless, for patients who want to avoid surgery, this data provides one more variable to consider when choosing the right type of sterilization for them. This is especially true since surgery after Essure failure can be riskier than the minimally invasive surgical sterilization would have been.

Adding to the controversy

The study comes at a particularly heated time as the FDA met at the end of September to reexamine Essure’s safety and effectiveness. Meanwhile Congress submitted a bill to have the device’s pre-market approval pulled. If passed, Essure would be unavailable within 60 days.

The increased risk of reoperation is not the only thing concerning the governmental bodies. Other unusual side effects, including pain, heavy or irregular periods, and fetal death in people who became pregnant after Essure was placed, were reported by over 5000 individuals since the device launched in 2002. Lastly, new data from Bayer, the device’s maker, came out earlier this year showing strong concerns about Essure’s safety.

What’s ironic about this whole situation is that if the device had been researched more thoroughly and improved as necessary, it could have been more popular, helpful, and profitable. Everyone would have benefited. Unfortunately, we know that both the FDA’s regularly processes and research paid for by a medical device or drug’s manufactur is problematic. Both of these come into play with Essure but only time will tell if they, along with some relatively small numbers of people with complications, are enough to pull it from the market.