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Cook Medical: Safety & Effectiveness of Transvaginal Mesh Depends on Material Used

Cook Medical has conducted a literature review stating that the safety and effectiveness of transvaginal mesh depends on the type of material used.

According to Cook Medical, the U.S. Food & Drug Administration’s recent report on transvaginal mesh does not discuss or distinguish the difference between several types of important biologic grafts. This lack of information led Cook to conduct a comprehensive literature review involving the various types of transvaginal mesh products. The vaginal mesh lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits nationwide on behalf of victims injured by transvaginal mesh side effects.

Free Transvaginal Mesh Lawsuit Case Evaluation: If you or a loved one has been injured by any variety of vaginal mesh product, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

September 7, 2011 – Cook Medical supports the FDA’s recent review of the issues surrounding the use of surgical mesh for the treatment of pelvic floor disorders and commends the administration’s open scientific discussion regarding these matters. However, Cook believes that the FDA has so far neglected to recognize the important differences between synthetic mesh products and biologic grafts in terms of tissue response, inherent risks, and successful clinical outcomes. The company has submitted a detailed review of the published clinical literature which provides compelling evidence for the safety of the newer so-called ‘non-crosslinked’ biologic grafts, and is encouraging the FDA to use this information when considering possible recommendations about the use of transvaginal mesh products in the future.

According to Cook, the FDA has grouped the different types of surgical mesh materials together and failed to acknowledge the vastly different clinical outcomes obtained with different materials. The company believes the success of any procedure involving mesh depends on at least three factors:

  1. assuring that the patient is a suitable candidate
  2. performing the procedure correctly
  3. choosing the appropriate product

Additionally, the FDA does not discuss what Cook views as the most significant difference between types of grafts, namely, chemically cross-linked vs. non-crosslinked grafts. And though the FDA does differentiate between synthetic and biologic-derived materials, the reviews fail to recognize the difference between chemically cross-linked and non-crosslinked biologic grafts when assessing safety and effectiveness. Finally, the administration’s report only provides one example in which consideration is given to the type of transvaginal mesh material used in a procedure, stating that ‘more than half of the women who experienced erosion from non-absorbable synthetic mesh required surgical excision in the operating room.’

Vaginal mesh products for pelvic organ prolapse repair can be divided into four groups:

  1. Synthetic, non-absorbable
  2. Absorbable synthetic mesh
  3. Chemically cross-linked biologic mesh
  4. Non-crosslinked biologic grafts

Cook’s literature review illustrates the following important differences between the safety and effectiveness of these types of biomaterials:

  • Non-absorbable synthetic mesh products are permanent implants that provoke a foreign body response. Non-crosslinked biologic grafts remodel into normal host tissue, thereby reducing long-term foreign body response, and do not leave behind foreign material that may have to be removed at a later date.
  • Non-crosslinked grafts have a lower erosion rate than their non-absorbable synthetic counterparts (1.2% vs. 10.0%).
  • Non-crosslinked biologic grafts have a low prolapse recurrence rate compared to non-absorbable synthetic mesh products (14.5% vs. 8.2%), especially when compared to standard colporrhaphy (30.0%).
  • Erosion associated with non-absorbable synthetic mesh products typically requires one or more surgeries to remove the mesh, while non-crosslinked biologic grafts allow natural remodeling and non-surgical management.
  • Recurrence of POP associated with non-absorbable synthetic mesh requires removing the mesh or attempting surgical intervention while the mesh is in place, while a non-crosslinked biologic graft is intended to eventually be reabsorbed by the body.

In conclusion, Cook’s review shows the medical literature strongly suggests that important differences exist between transvaginal mesh materials in terms of tissue response, risks, and overall successful clinical outcomes. It also provides convincing evidence of the safety and efficacy of non-crosslinked biologic grafts.

“Our number one priority is keeping patients safe while also improving their quality of life,” said Andy Cron, vice president of Cook Medical’s Surgery division. “Cook has and continues to work with physicians to develop surgical procedures and advanced materials that provide a lasting repair without a permanent synthetic mesh.”

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