"Second-generation" or "global" endometrial ablation devices hit the market in the late 1990s, with five approved from 1997 to 2003: Thermachoice (by Johnson & Johnson/Ethicon) Her Option (Cooper Surgical) Genesys Hydrothermal Ablation or HTA (Boston Scientific) NovaSure (Hologic) and the MEA System (Microsulis). The fluids used to open up the uterine cavity during hysteroscopy were being absorbed into the bloodstream, causing fluid overload, hyponatremia, and brain swelling. In the early 1990s, ob/gyns were using a hysteroscope - a device with a steep learning curve to operate - to continually look inside the uterus as they burned away tissue with either a rollerball or cutting-loop electrode.īut a handful of deaths due to hyponatremic encephalopathy were reported in the medical literature. NovaSure and its competitors represented a considerable improvement over earlier incarnations of endometrial ablation. Ultimately, the procedure should "lighten or end your heavy periods," according to a patient brochure. The RF energy delivered by that "wand" is "precisely measured" and only blasts away endometrium for about 90 seconds, the email says. They also lament economic losses from missed work due to complications, and the damaging impact ablation had on their relationships and their sex lives.Ī MedPage Today search of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database over the last 11 years for the most frequently used endometrial ablation device - NovaSure, made by Hologic - turned up hundreds of reports documenting serious harm: severe sepsis, bowel surgeries, hysterectomies, burns, perforations, and other events - including fatalities.
These women share stories of crippling pain, hemorrhaging on operating room tables, having bowel surgeries and hysterectomies, and becoming violently ill with sepsis.
Individual lawsuits have already been filed and product liability attorneys are advertising for clients. The most active Facebook group has more than 5,000 members, and a petition to pursue a class action lawsuit has nearly 1,700 signatures, with names still being added. and around the world are taking to Facebook groups and online petitions saying their ablation led to serious issues, and trying to warn others about their experience.