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A new study finds that women who used Essure for birth control tended to need follow-up surgery far more frequently than women who chose laparoscopic sterilization.
The study was published in the British Medical Journal in October 2015. Researchers led by Dr. Art Sedrakyan of Cornell studied over 50,000 women in New York State who underwent either Essure sterilization or laparoscopic sterilization between 2005 and 2013.
They found that the Essure patients were ten times more likely to need reoperation than those who opted for a laparoscopic sterilization procedure. That rate translates to roughly one out of fifty Essure patients needing follow-up surgery. The report described such a high rate as a “serious safety concern.”
Dr. Sedrakyan noted that even though the Essure device helps some women avoid surgery, the surgery to correct Essure complications is likely to be more complicated than the laparoscopic sterilization procedure the patient was hoping to avoid.
In addition to the findings about reoperation, the researchers found that about half the women who received an Essure device were given general anesthesia, which comes with its own risks of complications. Essure was designed so that it could be implanted without the use of general anesthesia.
No major studies of Essure have been done since those that were done prior to its approval for sale in 2002.
Dr. Sedrakyan said that women choosing a sterilization procedure should understand that Essure is not a low-risk procedure. He stopped short of recommending the device be taken off the market.
Essure Complications
An estimated 750,000 women have been implanted with the Essure device. Essure is manufactured by Bayer to be used for permanent birth control. It consists of a small metal coil that a physician implants through the vagina and into the fallopian tubes. After implantation, the body forms scar tissue around the implant, preventing fertilization.
Essure is marketed as a less invasive sterilization procedure than the more traditional tubal ligation surgery. While laparoscopic surgery is already considered “minimally invasive,” Essure is designed to be even less so and can be implanted on an outpatient basis, without any actual surgery.
Thousands of women have reported significant complications following Essure implantation. They report such problems as abdominal pain, allergic reactions, breakage of the device, perforation of the fallopian tubes, or migration of the device out of place.
As the recent study shows, many Essure complications are severe enough to require surgical intervention. Some women say they have required surgical removal of the fallopian tubes or even total hysterectomy.
The FDA has undertaken a review of the risks associated with the Essure device, following receipt of over 5,000 reports related to Essure since 2002. In a statement, the agency said it will take the results of the new study into consideration.
Despite the widespread reports of Essure complications, the FDA says it is not considering taking the device off the market. The agency may require Bayer to add new warning information to the device’s labeling.
In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.
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