FDA Response

The number of complaints to the FDA surrounding mesh comprises only a small percentage of the total surgeries performed, and mesh is still available to use as a treatment option.

The response from the FDA concerning mesh as a treatment option has been two-fold:

  1. The FDA issued a safety communication in 2008 and updated it in 2011 alerting patients and physicians to the rise in complaints. Patients were given an advised list of questions to ask before agreeing to mesh placement. Physicians were asked to carefully weigh risks and benefits of all options prior to recommending a course of treatment.
  2. The FDA is requiring manufacturers of transvaginal mesh and single-incision slings to participate in long-term, Post-Market Surveillance Studies – known as 522 orders. These studies can be required by the FDA for a number of reasons, including the long-term study of devices they are implanted in the body for 1 or more years. The pelvic floor surgical mesh studies will range in timing for each medical device manufacturer. They will begin in 2013 and are expected to be completed in 3-5 years from the start date.

The pelvic floor surgical mesh post-market studies will compare patient outcomes of various mesh implants currently available to physicians and patients with outcomes using a patient’s native tissue. These clinical study treatments are not experimental and patients treated outside the clinical studies may have the same procedures or implants as patients choosing to participate in the post-market study..

If you are interested in learning more about or pursuing treatment in conjunction with a 522 clinical study, you can find information about active studies on the ClinicalTrials.gov website.