New Study Raises Safety Concerns about Essure Birth ControlOct 19, 2015
According to a new study, the Essure permanent birth control system appears to have the types of safety problems many have women have complained of.
A research study just published in the online edition of the British Medical Journal found that women with the device had 10 times as many surgeries to correct problems as women who had surgical sterilization, NBC News reports.
Since Essure came on the market in 2002, thousands of women have reported problems with Essure, ranging from metal allergies to severe abdominal pain, organ perforation, and unplanned pregnancies. Last month, the Food and Drug Administration (FDA) convened an expert panel to gather scientific and medical evidence and hear the problems experienced by women who had been implanted with Essure. The device consists of a small pair of metal coils inserted into the fallopian tubes to create scar tissue that blocks the tubes and prevents pregnancy.
Dr. Art Sedrakyan of Weill Cornell Medical College in New York and colleagues analyzed data from 8,048 women who had Essure implants. They compared these women to 44,278 women who had standard surgery to block or "tie" their fallopian tubes between 2005 and 2013 in New York State, NBC News reports. "A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern," Sedrakyan said.
Essure, sold by Bayer, is marketed as a surgery-free alternative to minimally invasive laparoscopic sterilization surgery, which is done with a small incision. Essure can be implanted through the vagina, in a procedure in a doctor’s office. But the researchers found that women with Essure often ended up having surgery anyway. Essure helped women avoid surgery initially, "but they are still facing a 10-fold high risk of getting that surgery done," Sedrakyan told NBC News. About one in 49 or 50 women with Essure will require surgery. "And that surgery is likely to be much more complicated than the laparoscopic approach that they should be considering."
The FDA is not considering pulling Essure from the market, but will determine whether additional warnings should be added to the labeling. The FDA called this "a high priority issue for the agency." The FDA is reviewing the findings of the BMJ study, along with other medical literature and input from panel members and the public "to determine what future actions may be appropriate."
Bayer believes the device is safe for most women and feels that the BMJ study supports "the established high efficacy rate of Essure," Bayer said in a statement. The researchers found that women who chose Essure were more likely to be over 40 and to have other complications such as pelvic inflammatory disease, according to NBC News. Women with more health issues may have been more likely to opt for a nonsurgical method of sterilization.
Sedrakyan said that even small risks matter on a population level; more than 750,00 Essure procedures have been done, most of them in the U.S. While Sedrakyan does not say Essure should be pulled from the market, he said women need to understand the implantation is "not a low-risk procedure," according to NBC News. He recommends that women be tested for nickel allergies, which is not routinely done now, and could be important to the outcome.