Essure, the permanent contraceptive device that consists of a flexible coil made from nickel-titanium alloy, is getting a second look from the U.S. Food and Drug Administration (FDA) after receiving more than 5,000 reports of medical problems linked to the device.
The agency updated the short- and long-term risks associated with Essure on its website, and will convene a public advisory meeting September 24 that will bring together experts, doctors, and patient and industry advocates to review the data and hear public comments from women. The FDA may consider whether Bayer, the maker of Essure, will need to modify labeling or whether additional research is needed, according to NPR.org.
Clinical trial data shows that about nine percent of women experience mild to moderate pain during the procedure, and 13 percent experience it immediately afterward. Essure is also known to cause cramping, vaginal bleeding, nausea, vomiting, fainting and pelvic or back pain for several days after implantation. Rarely, the body can expel a coil, NPR.org reports.
Long-term risks include chronic pelvic pain; allergic reactions to the nickel in the coil; a coil that perforates the fallopian tubes or uterus; or cases where the coil migrates through the tubes, requiring surgery. Essure also puts women at greater risk of having ectopic pregnancies, according to NPR.org.
Elizabeth Micks, an OB-GYN and contraception specialist at the University of Washington Medical Center in Seattle, told NPR.org she would like to see more data on the long-term complications of Essure. The longest study available is a 10-year retrospective study.
“Most of the data we have are from the clinical trials, and you can’t necessarily go by the clinical trial data in looking at complications because obviously some women in real life practice aren’t following up, so we don’t really know if they have a malposition of their coils,” Micks said. “It’s frustrating to be told we don’t have the data, but I feel like the terrible cases I’ve seen are really people who were not properly informed about the risks and benefits ahead of time. I think the bigger problem is what physicians are communicating with patients.”
Some of the adverse events experienced by women with Essure are the result of physicians deviating from standard procedure. In one recent case, a woman’s follow-up x-ray showed improper placement of the coils. Laparoscopic surgery is the typical treatment for such a problem, but in that case, the woman underwent a second Essure procedure and was later found to have three coils perforating the uterus on one side. The patient also wound up getting pregnant, NPR.org reports.
Approximately 750,000 women have been implanted with Essure, but it’s not clear just how many have been injured by the device. Patients and doctors can report problems to the FDA’s Manufacturer and User Facility Device Experience database, but the system is passive, meaning anyone can report anything that happens, whether it’s actually related to the device or not. Some problems may be double- and triple-reported, while others may go unreported entirely, according to NPR.org.
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from Parker Waichman http://www.yourlawyer.com/blog/fda-meeting-will-discuss-injuries-and-side-effects-caused-by-essure/
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