This equivocates to roughly one out of 49-50 women needing surgery to repair or remove the device. Dr. Sedrakyan also added that the “surgery is likely to be much more complicated than the laproscopic approach that they should be considering. For its part, the FDA has acknowledged the study, releasing a statement saying “This is a high priority issue for the agency. The FDA plans to review the findings of this study, along with the latest medical literature on the Essure device and input from panel members and the public during our recent advisory committee meeting, to determine what future actions may be appropriate.” The FDA has not indicated, however, that it is planning on pulling the device from the market.
The first intensive study of its kind regarding Bayer’s controversial Essure birth control device, a coil-shaped implantable device made primarily of nickel. The device has been the focus of rampant complaints by users over chronic pain, skin allergies, and even unwanted pregnancy. Essure is marketed by Bayer as the only permanent birth-control device that does not require surgery; it is instead implanted in the fallopian tube through the vagina. Weill-Cornell Medical College’s Dr. Art Sedrakyan led a team of researchers in analyzing 8,048 women who chose to use the Essure device (hysteroscopic sterilization) and compared them with 44,278 women who elected to have surgery in which their fallopian tubes were tied or blocked. The results of the study were published October 13th in the online version of the British Medical Journal. Although the device was supposed to be a less invasive procedure than the surgery (laparoscopic sterilization), the study’s results prove otherwise.
Instead of finding Essure as a tool to keep women off of the operating table, Dr. Sedrakyan wrote, “We found tenfold higher risk of repeat surgery after Essure when compared to laparoscopic surgery. This means that nationally more than 10,000 women likely underwent additional surgery in the past five years.” This equivocates to roughly one out of 49-50 women needing surgery to repair or remove the device. Dr. Sedrakyan also added that the “surgery is likely to be much more complicated than the laproscopic approach that they should be considering. For its part, the FDA has acknowledged the study, releasing a statement saying “This is a high priority issue for the agency. The FDA plans to review the findings of this study, along with the latest medical literature on the Essure device and input from panel members and the public during our recent advisory committee meeting, to determine what future actions may be appropriate.” The FDA has not indicated, however, that it is planning on pulling the device from the market.
The findings affirm what the 20,000+ women of the Facebook user group “Essure Problems” have been advocating for years: the device causes serious health risks. The group expressed their frustrations as an independent Food and Drug Administration (FDA) panel reviewed the device’s health risks on September 24th. Although the panel raised concerns about the health risks and the data in studies used to support Essure’s 2002 FDA pre-market approval (PMA), the panel recommended additional studies of the device’s health concerns; it did not push for the device’s removal from the market. Much like what occurred at the September 24th panel meeting, however, the Weill-Cornell team did not go as far as call for an outright ban of the device, but instead wants the company to provide additional warnings that implanting Essure devices is not a low-risk procedure. Sedrakyan said, “I hope that they will weigh the risks and harms in our study, talk to their clinicians about their specific conditions,” while also encouraging women to undergo skin allergy tests before considering the device. According to the National Institute of Health, 17 percent of all women have an allergy to nickel.
Much like what occurred at the September 24th panel meeting, however, the Weill-Cornell team did not go as far as call for an outright ban of the device, but instead wants the company to provide additional warnings that implanting Essure devices is not a low-risk procedure. Congressman Mike Fitzpatrick (R-PA) has responded to calls on social media to force the FDA to revoke Essure’s PMA status by crafting the “E-Free Act.” Fitzpatrick intends on introducing the bill next week, which requires the FDA to pull the product from the market within six months. Bayer representatives interpreted the study far differently than the researchers, writing in a statement, “Over a decade of research and development and a decade of real world experience supports the safety and efficacy of Essure. The findings of the BMJ article published on October 13, 2015 further support the established high efficacy rate of Essure.” Dr. Sedrakyan warns however, “There are over 750,000 procedures done, so far most of them in United States, so we believe this is commonly done procedure, and even small risk matters on a population level.”
Sources:
NBC News – Maggie Fox
Weill-Cornell Medical College – Newsroom
Join the conversation!