FDA Strengthens Regulatory Requirements for Transvaginal Mesh

On Monday, January 4^th, the FDA released two final orders which increased the regulation of surgical mesh used to repair pelvic organ prolapse (POP). The orders were developed in order to strengthen the data requirements for the device.

Background

The timeline below briefly summarizes the history of the use of surgical mesh:

Over the past several years there has been a substantial upsurge in the number of adverse events related to the device’s use in the transvaginal repair of POP. According to a recent press release, “the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.”

In response to the increase in complications, the FDA has taken a number of actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair. These actions include:

• 2008 & 2011: Issued safety communications to warn doctors and consumers about the upturn in issues related to surgical mesh used for urogynecological procedures.
• September 2011: Assembled an advisory panel to explore recommendations on actions to take regarding urogynecologic surgical mesh for transvaginal POP repair.
• January 2012: Issued orders to manufacturers mandating them to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.
• May 2014: Issued two proposed orders, in which the Agency suggested the devices be reclassified as class III devices (rather than class II), and to require manufacturers to submit a PMA application.

Final Orders

Earlier this week the FDA finalized both orders that were proposed more than a year and a half ago. The orders will:

1. “Reclassify these devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices.”
2. Require a premarket approval (PMA) application be submitted by manufacturers, showing evidence of safety and effective of the surgical mesh for the transvaginal repair of POP.

The Agency’s goal is to reduce the risks related with the use of these devices. By requiring manufacturers to address the safety concerns, pelvic pain, and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness, we are hopeful that these requirements will help FDA achieve its goal.

Press Release

The FDA published a press release to announce the finalization of the orders. In the announcement, William Maisel, MD, PhD, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health (CDRH), said “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

The timeline for compliance was addressed by FDA in the press release as follows:

“Manufacturers of surgical mesh to treat POP transvaginally will have 30 months, as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.”

In addition, the release explicitly states that the orders apply only to mesh devices marketed for the transvaginal repair of POP, and they do not apply to surgical mesh for other indications (e.g. stress urinary incontinence (SUI) or abdominal repair of POP).

For additional information on pelvic organ prolapse (POP), visit the FDA's website here.

Are you a manufacturer of surgical mesh for the transvaginal repair of POP? Are you in the process of developing a mesh device to treat POP transvaginally? Are you already marketing a device? Regardless of where you are in the process, we can help you become compliant with all of FDA’s requirements. For more information on our services and how we can help you achieve a successful interaction with FDA, please contact us.