Medical Devices

Urogynecologic Surgical Mesh Implants

November 20, 2018 - Update on the FDA's actions to strengthen requirements for surgical mesh intended for transvaginal pelvic organ prolapse (POP) repair

The FDA is taking further steps to assure women's health and access to safe and effective medical devices. The FDA's efforts on urogynecologic surgical mesh have focused on identifying  benefit-risk concerns related to some of these devices, and strengthening the FDA's regulatory oversight to protect patients, while enabling those who need these devices to benefit from them. Providing patients with access to the safest possible medical devices on the market to meet their health care needs remains a top FDA priority.

In 2011, the FDA issued an FDA Safety Communication, which identified concerns about the use of surgical mesh for transvaginal repair of pelvic organ prolapse , and convened a public meeting of the Obstetrics and Gynecology Devices Panel to discuss the benefits and risks of this use. Subsequently, the FDA issued 131 orders to conduct postmarket surveillance studies (“522 orders”) to 34 manufacturers of surgical mesh for transvaginal repair of pelvic organ prolapse. Most manufacturers elected to stop marketing surgical mesh for transvaginal repair of pelvic organ prolapse after receiving their 522 orders. Currently, there are four ongoing 522 studies for five devices.

On January 5, 2016, the FDA reclassified surgical mesh for transvaginal repair of pelvic organ prolapse into class III, which require premarket approval (PMA) applications, the agency's most stringent device review pathway. The FDA mandated that premarket approval applications be filed by July 5, 2018 for any surgical mesh marketed for transvaginal pelvic organ prolapse repair. As a result of the FDA's actions, all manufacturers ceased marketing of surgical mesh intended for transvaginal repair of posterior compartment prolapse (rectocele). In addition, only three surgical mesh products intended for transvaginal repair of anterior compartment prolapse (cystocele) remain on the market while FDA reviews their premarket approval applications.

On February 12, 2019, the FDA plans to convene an advisory committee meeting to share the available evidence and seek expert opinion about the safety and effectiveness of surgical mesh intended for transvaginal POP repair. This meeting will also provide the public, including patients, an opportunity to comment.

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.

Animal-derived mesh are made of animal tissue, such as intestine or skin, that have been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine).

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement in strength to the urogynecologic repair. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.

Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI. There are three main surgical procedures performed to treat pelvic floor disorders with surgical mesh:

  • Transvaginal mesh to treat POP
  • Transabdominal mesh to treat POP
  • Mesh sling to treat SUI

Each of these procedures has unique risks and benefits and it is important not to confuse the procedures and the risks and benefits.

In this website, the FDA describes POP and SUI, the different surgical and non-surgical treatment options, recommendations for health care providers that treat women with POP and/or SUI, recommendations for patients who are considering surgery for these conditions and steps to report problems to the FDA. This information is to help patients make informed decisions about their health care and to facilitate a discussion between patients and their health care providers about treatment options. The information provided on this website is not meant to replace a discussion with your health care provider.


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Page Last Updated: 12/07/2018
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