The FDA issued a Consumer Update on November 15 with the new boxed warning and patient checklist.
One woman who asked the FDA to ban Essure is Kim Myers, a former rodeo-style barrel racer from Mississippi. She stopped riding horses when Essure perforated her fallopian tubes and caused chronic pain.
After surgery to remove Essure, Ms. Myers continued to suffer pain. “Doctors kept saying there was nothing wrong with me,” she said. “I knew, with every fiber of my being, there was still something there.”
She was right — doctors discovered a broken piece of the metal coil embedded in her uterus. The pain only subsided when she had a hysterectomy, three years after Essure was implanted in her body.
Complications associated with removing Essure are not uncommon. Dr. Julio Novoa, an OB-GYN based in Texas who has reviewed hundreds of cases told Modern Healthcare:
It’s like grabbing a Slinky and trying to pull it when it’s attached to cement. It unravels, and it just snaps on you. You have a lot of doctors making mistakes removing them. It’s really bad, even when there’s a tiny fragment left behind.”
Fourteen months ago, Ms. Myers and many other women testified before the FDA and urged the agency to pull Essure off the market.
After a year-long safety review, FDA concluded that “Essure is safe and effective for many women, but also that some women experience very serious and sometimes debilitating problems.”
The actual rate of problems is unknown, but the FDA received 9,900 reports between November 2002 and December 2015 — with 280 reports noting that Essure was difficult to remove.
Essure is promoted as a 10-minute outpatient procedure with less pain and a faster recovery than tubal ligation (“having tubes tied”). It has fewer short-term side effects, but much higher long-term risks.
Surgery to remove Essure is often required when complications occur. One study involving 52,000 women found a 10-fold increased risk of follow-up surgery. The risk was 2.4% for Essure vs. 0.2% for tubal ligation.
Source: New York Times