Cook Biotech Inc. Urges The FDA To Consider New Information When Deliberating Vaginal Mesh Recommendations

In response to the upcoming advisory committee, scheduled to meet on September 8-9, Cook Biotech Incorporated has submitted information to be considered by the U.S. Food and Drug Administration (FDA) regarding the safety and effectiveness of transvaginal mesh products used in the treatment of pelvic organ prolapse (POP).

An influx of adverse transvaginal mesh reports have become the subject of intense scrutiny in the healthcare community. The past two years have witnessed an exponential growth in complications associated with the surgical application of transvaginal mesh products. Due to the frequency and severity in which these adverse events are being reported, a public advisory committee to the (FDA) has announced that they will hold a meeting to discuss safety and effectiveness concerns regarding the use of transvaginal mesh in the treatment of POP.

Cook Biotech Incorporated is a privately-held multinational medical device manufacturer who has provided physicians with a means of diagnosis and intervention with innovative products for surgical applications for nearly 50 years. For the last 13 years, they have designed and manufactured transvaginal mesh products intended to assist in the treatment of POP. Their products have been used in over 10,000 patients for the soft tissue repair of pelvic floor defects. Given their relevant background on the subject at hand, Cook has submitted statistical data pertaining to the safety and effectiveness of transvaginal mesh products to the FDA to be reviewed at the upcoming meeting.

The data submitted by Cook Inc. suggests that the benefits of transvaginal mesh outweigh the risks. In a letter to FDA officials, Cook representatives acknowledge that an important difference exists between bio-materials, in terms of tissue response, risks, and successful clinical outcome. Cook argues that non-absorbable synthetic mesh products are permanent implants that elicit a foreign body response. Whereas non-cross-linked biological grafts remodel into normal host tissue. Subsequently, biological transvaginal mesh products do not leave behind any foreign material that may cause future complications.

Cook Medical Comments continue to support the use of biological transvaginal mesh products by identifying that they have a significantly lower erosion rate than non-absorbable synthetic mesh products (1.2% vs. 10.0%). Further evidence suggests that non-crosslinked transvaginal mesh products have an acceptably low objective prolapse reoccurrence rate (15.5%). A rate such as this is substantially low compared to synthetic mesh that leads to a 30% reoccurrence rate.

Cook’s letter to the FDA carefully identifies the differences between biological and synthetic mesh products. Careful to acknowledge the dangers associated with synthetic grafts, the letter identifies that the body recognizes the transvaginal mesh as a foreign invader which allows severe complications to ensue. However, non-crosslinked biological grafts are comprised of acellular matrices, derived primarily from dermis. They demonstrate a propensity for cellular infiltration, proliferation, and remodeling of host tissue. Subsequently, biological transvaginal mesh products significantly reduce the risk of long-term foreign body response and severe complications.

According to the letter, “any literature review has limitations, as FDA’s own report acknowledges when presenting its results. However, Cook’s review shows that the literature strongly suggests that important differences exist between bio-materials in terms of tissue response, risks, and successful clinical outcome. Additionally, it provides strong evidence of the safety of non-crosslinked biologic grafts, such as those provided by Cook and other companies.”

Cook has urged the FDA and the Obstetrics and Gynecology Devices Panel to consider their submitted information when deliberating recommendations and future regulations. Cook insists that that non-absorbable synthetic mesh products and biological transvaginal mesh products have different risk profiles. Subsequently, recommendations concerning labeling, post-marketing studies, and reclassification should be made based on the risk profiles of different transvaginal mesh products.

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