The Food and Drug Administration has ordered 33 companies to conduct safety and efficiency trials concerning injuries associated with their transvaginal mesh products. Major companies, including Johnson & Johnson and C.R. Bard, will review their products and conduct a combined 88 surveillance studies over three years.
The FDA’s order comes in response to a high number of reported cases of failing transvaginal mesh. A panel of experts commissioned by the FDA concluded in July that the surgical mesh may pose an unnecessary risk to women without any additional therapeutic benefit. Women with failing mesh may experience debilitating pain, internal bleeding, organ damage or other complications.
The transvaginal mesh patch was approved to treat pelvic organ prolapse and stress urinary incontinence, but never underwent serious testing. Reports of complications from the device were five times as high as alternative forms of treatment, leading to more than 600 transvaginal mesh lawsuits that were filed as of September 2011.