Pharmaceutical

Consumer Reports takes aim at FDA’s device approval process

Janet Holt’s doctor told her that surgery to remove her uterus and insert a bladder lift would have her out of work for just two weeks. After that, she should be able to return to work on the family’s cattle ranch and small chain of restaurants in Floresville, Texas. That was 2007, and Janet has yet to return to full-time work. In the weeks and months following surgery, Janet was in so much pain she couldn’t sit or stand and could barely walk.

The problem turned out not to be the surgery, but the bladder lift device – a patch of surgical mesh that was implanted through her vagina into the vaginal wall. Over time, the mesh shrank and shifted, eventually working its way out of the vaginal wall. So far, she has had eight surgeries to remove and adjust the mesh. She still has painful nerve damage in one leg.

Vaginal mesh, or transvaginal mesh, is used not only for bladder lifts but also for other pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. They are common conditions that are caused by age, obesity or childbirth.

The devices came onto the market in the early 2000s. Since then, the Food and Drug Administration (FDA) has received thousands of reports of problems associated with the devices. Many of the victims, including Janet, have filed lawsuits against manufacturers of the mesh.

“How did it happen?” asks Consumer Reports, who has taken aim at the FDA for allowing such products on the market. The consumer group says the federal agency’s approval process is flawed. It allows medical devices to be approved without testing if similar products are already on the market.

About 10 years after the first transvaginal mesh kits were allowed on the market, the FDA is finally taking action. It ordered 33 companies to conduct the first-ever post-market safety studies of the mesh. The agency is also considering reclassifying mesh products as high risk, a process that could take years. Consumer Reports is fighting for the public because, the group says, these are dangers consumers are facing in the current marketplace.

Source: Consumer Reports