Doctor concerned with health care law

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Health Law Daily, January 5, 2016

After thousands of reported complications, transvaginal surgical mesh now a ‘high-risk’ device

By Mary Damitio, J.D.

In response to a significant increase in the number of reported adverse events such as organ perforation, infection, and bleeding that have been associated with the use of surgical mesh for transvaginal pelvic organ prolapse (POP) repair, the FDA has issued two Final rules intended to strengthen manufacturer data reporting requirements for the devices. The Final rules, which are effective as of January 5, 2016, reclassify surgical mesh used for transvaginal POP repair as Class III, high-risk devices (81 FR 354), and require manufacturers to submit premarket approval applications (PMAs) to demonstrate their safety and effectiveness (81 FR 364).

POP. Women can experience POP after the muscles and tissues of the pelvic floor are weakened and can no longer support organs such as the bladder, bowel, or uterus. As a result, the organs can drop and bulge or prolapse into the vagina, which can cause low back pain, pelvic pressure, painful intercourse, constipation, and urinary problems. Doctors can perform minimally invasive transvaginal surgery to address significant POP symptoms, during which surgical mesh can be permanently implanted to strengthen weak pelvic floor muscles.

Adverse events. In 2002, the first mesh device marketed for transvaginal repair of POP was approved as a Class II moderate-risk device. The FDA has since seen a “significant increase” in the number of reported adverse events associated with the use of the devices. The agency has received thousands of reports of complications, such as severe pelvic pain, infection, bleeding, organ perforation, painful intercourse, and urinary problems caused by mesh eroding into surrounding tissue.

In 2011, an expert advisory panel determined that more data is needed to establish the safety of the devices. The FDA subsequently took action to warn doctors and patients about the use of the devices and proposed rules seeking to reclassify the devices and require PMAs from manufacturers (see Premarket approval applications required for transvaginal surgical mesh in event of reclassification, May 1, 2014).

PMA. Manufacturers will now have 30 months in which to submit PMAs for devices that are already on the market and will be required to submit PMAs for any new devices. The FDA states that the PMA process will force manufacturers to address such safety concerns associated with the devices. However, the PMA requirement does not apply to surgical mesh that is used for other indications such as stress urinary incontinence (SUI) or abdominal repair of POP.

MainStory: TopStory MDNews FDCActNews MDeviceNews SafetyNews

Back to Top

Health Law Daily

Introducing Wolters Kluwer Health Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.