Transvaginal mesh: FDA orders remaining products off US marketBMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l1839 (Published 18 April 2019) Cite this as: BMJ 2019;365:l1839
- Owen Dyer
The US Food and Drug Administration has told the two manufacturers of the remaining three transvaginal mesh products to present a plan within 10 days for withdrawing from the US market, after they failed to provide evidence to allay safety concerns.
More than 100 000 women have sued over transvaginal mesh devices, complaining of symptoms such as persistent vaginal bleeding or discharge, chronic pelvic pain, or pain during sex.
Boston Scientific, which makes two of the three devices, has been named in 48 000 lawsuits by women claiming injury. The maker of the other device is a Danish company, …