New Research Reveals Essure Has Higher Need for Reoperation

New research reveals concerns about Essure, a permanent birth control device, which is already at the center of controversy.

Essure Reoperation

New Essure Reoperation Study

Researchers found a 10-fold higher risk of needing a reoperation during the first year for women who choose the Essure implant compared to those who had minimally invasive surgery for sterilization. The device works by preventing conception in blocking the fallopian tubes with nickel coils.

The new study focuses on the need for new surgical procedures tied to the use of Essure. Co-author of the study, Dr. Art Sedrakyan, is a professor of Healthcare Policy and Research at Weill Cornell Medical College and New York Presbyterian Hospital in New York City. The study estimated that more than 10,000 U.S. Essure patients have needed reoperations over the past few years. Sterilization with Essure does offer benefits compared to other types of procedures and it’s unknown how many of the reoperations were required due to serious medical problems.

However, Sedrakyan states that  “it is a serious issue given the large number of procedures,” especially because of the fact that “surgery after failure of Essure is much more serious compared to the approach that women were trying to avoid initially when choosing Essure.”

The device can be implanted in a doctor’s office, which allows women undergoing tube-blocking sterilization to avoid general anesthesia and a hospital stay. The need for a reoperation fully negates this “so-called” benefit of Essure.

Essure Operation Statistics

Sedrakyan uses statistics from New York state to estimate that about 25 to 30 percent of women undergoing sterilization use the Essure device. The study compared close to 8,000 patients who chose Essure to more than 44,000 patients who had sterilization via minimally invasive surgery that seals off the fallopian tubes, or what is more commonly referred to as getting your “tubes tied.” These patients were treated from 2005-2013 in New York state.

The new study also found that Essure procedures were more expensive, with a median of $7,800 compared to $5,100 with a surgical procedure.  According to the study, 2% of Essure patients required reoperations later on compared to only 0.2% of surgical patients. This difference remained even after the researchers adjusted their statistics to account for age and health problems.

Sedrakyan believes this study to be unique in that it represents Essure’s “safety in terms of the major outcome that patients care about: the need to undergo surgery, which is not a minor event. In fact, in some instances, device failure might involve a major intervention to fix the complications.”

Dr. Kristina Tocce, an associate professor at the University of Colorado Denver, states that some of her patients choose Essure due  to the fact that they wouldn’t easily tolerate other kinds of procedures due to medical complications like obesity or scarring from previous abdominal surgery. Tocce believed Essure would become more common than surgery, but negative press about the device has “dissuaded a lot of patients from pursuing it as an option. I’ve seen a lot of patients who have been scheduled for it but cancelled once they went online and read about this controversy.”

In terms of the new study, Tocce says its finding are valuable, however it’s not a prospective study. Tocce believes that is the gold standard of research in which “you enroll patients and watch what happens.” In addition, Tocce stated that it’s not clear how many of the reoperations were for serious conditions or if they were reattempts because the coils couldn’t be placed on the first try.

Bayer’s Response to Essure Risk

Bayer Healthcare, the makers of Essure, took issue with these new findings. In a statement from the company, they noted that the study “is based on a single database of one U.S. state and it is unclear if the data includes patients who underwent Essure in office settings.” In addition, the company stated that women who have had Essure are typically examined by their doctor three months after the device is implanted. No such follow up is required for women who get their tubes tied, so Bayer believes opportunities to spot potential problems are higher for women who use Essure versus who using other methods of sterilization. This is what is known as “detection bias.”

Tocce states that, going forward, women interested in permanent sterilization should consider their health situations. The professor also noted that the need for a follow-up exam in Essure patients is crucial.

So, should women who have already undergone sterilization with Essure worry? 

According to Tocce, no. However, according to this new Essure study, there is cause to worry. While 2% of Essure patients requiring reoperation may not seem like a huge number, compared to the 0.2% of reoperations with surgical patients, that is a gigantic difference. The percentage translates into about 21 additional surgeries per 1,000 patients getting Essure. If the New York stats for this device were applied to the rest of the United States, it would mean about 150,000 patients would need follow-up surgery.  With numbers like this, it should be clear that more studies are needed on this harmful device.

If you, or a loved one, had the Essure implant and suffered adverse side effects, you may be entitled to compensatory damages. Don’t let the manufacturer practice profit over people.

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Source: US News Health, Fierce Pharma