Essure Sterilization Device Causes 'Serious Safety Concern': Study

Image: Bayer's birth control implant Essure
This product image provided by Bayer Healthcare Pharmaceuticals, Inc. shows the birth control implant called Essure. Federal medical experts on Monday, Sept. 21, 2015 said it will take a closer look at a host of problems reported with Essure, including chronic pain, bleeding, headaches and allergic reactions.Bayer / Bayer via AP

A new study appears to confirm what some women have said about a permanent birth control device called Essure.

Researchers found that women who used the device had 10 times as many operations to fix problems as women who had surgery instead.

The Food and Drug Administration is taking a look at the complaints about the device — a pair of metal coils inserted into the fallopian tubes. Thousands of women say they’ve had problems after being fitted with it, from allergies to the metal used to severe abdominal pain.

The only big studies that have been done were for the approval of Essure, which hit the U.S. market in 2002.

Dr. Art Sedrakyan of Weill Cornell Medicine in New York and colleagues analyzed data from 8,048 women who got Essure implants and compared them to 44,278 who had standard surgery to block or “tie” their fallopian tubes between 2005 and 2013 in New York State.

"A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern."

Essure, sold by Bayer, is advertised as a surgery-free alternative to minimally invasive laparoscopic surgery, which is done with a small incision. Essure can be implanted through the vagina.

But Sedrakyan’s team found that women who got Essure often ended up in the operating room, anyway. The risk of having a second procedure was 10 times higher in women who got Essure than among women who got laparoscopy, they reported in the British Medical Journal's online version.

"A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern," the team wrote in their report.

“Essure helped them avoid surgery in some instances, but they are still facing a 10-fold high risk of getting that surgery done,” Sedrakyan told NBC News.

“And that translates to one in 49 or 50 women getting this surgery again,” he added.

“And that surgery is likely to be much more complicated than the laproscopic approach that they should be considering.”

The team did not find that the risk of getting pregnant anyway was any greater with Essure than with surgery. They did find that although the device is supposed to be placed without the use of general anesthesia, which can itself be dangerous, about half the women were put under, anyway.

The FDA is not considering pulling the device off the market, but will determine whether extra warnings should be added.

"This is a high priority issue for the agency," the FDA said in a statement. "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."

Bayer says it believes the device is safe for most women.

"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," Bayer said in a statement.

Sedrakyan’s team did find that women who got Essure were more likely to be over 40 and to have other complications such as pelvic inflammatory disease. Bayer says the safety of Essure in women over 45 isn’t known. Women with more health complications may have been more likely to opt for a surgery-free method of sterilization.

The company also warns of side-effects including pain and the risk that the little spring might break.

“In rare cases, part of an Essure insert may puncture the fallopian tube. Surgery may be necessary to repair the puncture,” Bayer says on its website.

"We believe this is commonly done procedure, and even small risk matters on a population level."

Sedrakyan says the risks add up.

"There are over 750,000 procedures done, so far most of them in United States," he said. "So we believe this is commonly done procedure, and even small risk matters on a population level."

Sedrakyan didn't say the device should be banned but he said women need to understand that it’s not a low-risk procedure.

”I hope that they will weigh the risks and harms in our study, talk to their clinicians about their specific conditions,” he said.

“I also encourage them to get tested, and insist on getting tested for metal allergies and nickel allergies, and that is not done routinely right now and that could be important.”

Jane Derenowski contributed.