The Senators (Ret.) Firm, LLP How can we help you?
Haga clic aquí para visitar nuestro sitio web en Español
800.773.0849
Learn more about the different types of sexual abuse. Learn more about product liability The Senators Firm
Accolades and Associations
BlogHeaderContent
Contact Us

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.

Do I Have a Transvaginal Mesh Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in transvaginal mesh lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by transvaginal mesh, you should contact our lawyers immediately by clicking the link below or calling toll free 1-800-773-0849. You may be entitled to compensation for your injuries and we can help.

Categories: Product Liability
Your Legal Rights If you or someone close to you has become a victim of sexual abuse, please contact us to learn more about your legal rights.
800.773.0849
Attorney Web Design The information on this website is for general information purposes only. Nothing on this site should be taken as legal advice for any individual case or situation. This information is not intended to create, and receipt or viewing does not constitute, an attorney-client relationship.

View Full Disclaimer

The Senators (Ret.) Firm, LLP - California Lawyer
Located at:
19100 Von Karman Ave
Suite 850

Irvine, CA 92612

View Map
Phone: (800) 773-0849
Website:
© 2018 All Rights Reserved.
Friend us on Facebook Follow us on Twitter View our Google+ Page