Medical Devices

Urogynecologic Surgical Mesh Implants

September 19, 2017 - Update related to raw material used to manufacture Boston Scientific urogynecologic surgical mesh.

After extensive review of data and information from various sources available to the FDA, including data and information from Boston Scientific and results from the FDA’s own testing of the finished product, the FDA has determined that the change in supplier of the polypropylene used to manufacture Boston Scientific’s urogynecologic surgical mesh currently on the market does not raise new safety or effectiveness concerns.

In January 2016, the FDA became aware of allegations that Boston Scientific's urogynecologic surgical mesh may contain counterfeit raw material, specifically a polypropylene resin. While we were not aware of any patient adverse events related to the use of this new polypropylene, we examined these allegations to determine any necessary next steps. During our review, we learned that Boston Scientific changed suppliers of the polypropylene resin used in the manufacture of their mesh. It is not uncommon for a firm, based on its own evaluation of potential suppliers and raw material, to change the source of a raw material after the device has been cleared by the FDA. Such changes must be consistent with both the FDA’s Quality System regulations and premarket notification regulations.

The FDA examined Boston Scientific’s supplier change in both contexts. During the course of our evaluation, the FDA conducted inspections of Boston Scientific and contract facilities involved in the manufacture of urogynecologic surgical mesh products. The FDA collected samples during the inspections, and reviewed mechanical performance testing and sterility testing of the final mesh devices. The FDA also reviewed Medical Device Reporting data and recall data, and conducted a clinical assessment of Boston Scientific’s urogynecologic surgical mesh products. In addition, the FDA reviewed test reports regarding the chemical characterization of the polypropylene resin, and biocompatibility and mechanical performance testing on the final product.

The FDA determines the safety and effectiveness of finished products, not raw materials. However, in this case, to thoroughly address the allegations, we reviewed testing of the polypropylene raw material, as well as the finished mesh manufactured with polypropylene resin from both sources.

We found variability between the polypropylene resin from both suppliers, but determined, based on the information available to us, that these differences do not present new safety or effectiveness concerns, and do not require submission of a new premarket notification. Our previous update on the issue is available online.

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: 08/30/2018
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