A controlled study of the sterility device Essure found that women who were implanted with the device were 10 times more likely to need reoperations.
Due to complaints of many women allegedly suffering from unexpected side effects due to the implant, a study was conducted to determine if the device is still safe to use.
Based on the findings, women with Essure implants have undergone 10 times more operations than women who opted for standard sterility operations to fix the problem with their implant.
The study findings were based on data gathered from more than 8,000 women who had Essure implanted. The data which were then compared to those taken from at least 44,200 women who had standard sterilization surgery like tubal ligation done between 2005 and 2013.
"A more than 10-fold high occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern," reported the team, lead by Dr. Art Sedrakyan, from Weill Cornell Medical College, Cornell University.
While Essure may have helped some patients avoid sterility surgery, there is still a big risk that they will have to undergo it anyway due to the growing list of problems associated with the device.
This, Sedrakyan said, means that there could be one out of at least 49 women with Essure implants who will have to get surgery again, and that the procedure will likely to be a major surgery.
Essure, manufactured by Bayer, was touted as a non-surgical implant for the vagina, which has an equal success rate for preventing pregnancies as sterility surgeries. The device works by causing inflammation at the fallopian tubes, the resulting tissue growth blocking the sperm from fertilizing an egg.
Essure is not without warnings and side effects, as patients are warned to expect nausea, vomiting, vaginal bleeding and cramps immediately after the procedure. But more women are complaining of unexpected adverse reactions to the device including hair loss, severe chronic pain, irregular bleeding and mood swings.
The complaints grew and have affected so many that a Facebook page was dedicated to it, aptly named Essure Problems.
Bayer was prompt in defending the safety of the use of its product, stating that Essure was effective at what it was meant to do with a good risk to benefit profile. The company did express its desire to cooperate with the Food and Drug Administration (FDA).
"Patient safety is Bayer's top priority," said Dr. Michael Devoy, chief medical officer of Bayer HealthCare. "We continue to believe that the benefits of Essure continue to outweigh its risks."
The FDA is currently looking into the safety concerns regarding Essure, although there is still no call on whether or not the device will be pulled out of the market.
