Medical device makers to pay more for product safety reviews

The Food and Drug Administration (FDA) is doubling its fees to medical device makers who want their products reviewed in order to market them in the United States. The increase will allow the federal agency to hire 200 new full-time employees to carry out more detailed reviews and allow more time for device manufacturers to address concerns about safety issues.

The fee increase, which will first have to be approved by Congress, comes just months after the agency’s accelerated approval process for moderate-risk medical devices was criticized for allowing medical devices to be marketed without adequate testing, putting the public’s safety at risk. Under this process, medical devices are approved without clinical trials if they are similar to ones already on the market.

Many devices that pass through the approval process with only scant review include transvaginal mesh. This surgical mesh is inserted into the vagina to shore up organs that have fallen, or prolapsed, due to childbirth, age or obesity, a condition known as pelvic organ prolapse.

Surgical mesh has been used for the repair of hernias and other conditions with few problems; however, when it was used transvaginally, the mesh was found in many cases to erode into the vaginal wall, causing pain, inflammation, incontinence, and other complications. Many women have had to be hospitalized and undergo repeat surgeries to remove the mesh, which in some cases is impossible.

As part of an FDA advisory panel review to discuss the safety of the devices, the panel fell short of recommending that transvaginal mesh be banned, opting instead to recommend that the devices undergo clinical trials to determine their safety and efficacy before they are approved for use.

Source: Business Week