What’s Billed As Quick, Easy Procedure To Fix Heavy Periods Turns Into Nightmare For Many Patients
MedPage Today investigates the fallout from selling patients on an endometrial ablation with a NovaSure device. Now thousands of women in the U.S. 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.
Women Burned By Quick Fix For Heavy Periods
Tanya Perry was looking for relief from heavy bleeding during her period when her ob/gyn suggested endometrial ablation with the NovaSure device in May 2017. Her doctor told her it would be a quick and easy procedure, and she'd be able to go home the same day. The thin device would be inserted through her cervix into her uterus, and it would burn away her endometrial lining using radiofrequency (RF) energy. Less endometrium would mean less bleeding. (Fiore, Firth and Hlavinka, 1/29)
How We Used FDA MAUDE Data On NovaSure
Attuned to the limitations of FDA Manufacturer and User Facility Device Experience (MAUDE) data, the MedPage Today investigative team was conservative in its evaluation of reports appearing in the database. Team members searched on the brand name NovaSure for the full years from 2009 through 2019. (Reports for 2009 were removed on Jan. 1, 2020, as the public database is trimmed annually to reflect only the previous 10 years.) (Fiore, Firth and Hlavinka, 1/29)