August 30, 2011 — In a letter addressed to the FDA, transvaginal mesh manufacturer Cook Biotech Inc. is urging panelists to consider different types of transvaginal mesh materials in their public advisory committee deliberations. According to Cook, patients who receive non-crosslinked biologic mesh products during surgery have lower risks of erosion or recurrence, compared to synthetic materials. The company is requesting the FDA panel account for the different risk rates associated with mesh materials when they make recommendations about the future of transvaginal mesh products.
Cook Biotech Incorporated (Cook) estimates its non-crosslinked biologic graft products have been used in over 10,000 soft tissue repair surgeries over the last 13 years, during pelvic organ prolapse (POP) and stress urinary incontinence (SUI) treatment.
Because the FDA believes complications from transvaginal mesh repairs of POP are not rare, it asked a public advisory panel to convene September 8-9, 2011 in Maryland. The panel will discuss the safety and effectiveness of transvaginal mesh procedures. Following the discussion, the panel is anticipated to make recommendations about the future of transvaginal mesh repairs, including the possibility of harsher restrictions or a reclassification of the products.
While Cook acknowledges that the FDA’s recent report raises legitimate concerns regarding transvaginal mesh products, Cook criticizes the FDA for lumping all forms of transvaginal mesh together and for not considering how the body responds to different types of mesh material.
According to Cook, monofilament polypropylene mesh is the current mesh of choice in POP repair, as it is used in the majority of surgeries. However, Cook believes there are significant differences between non-absorbable synthetic mesh products and non-crosslinked biologic grafts in terms of erosion and recurrence risk. In its August letter, Cook submitted information about the mesh types it believes the public advisory panel should consider in its deliberations.
Cook divides POP repair materials into four categories:
- Synthetic, non-absorbable mesh
- Absorbable synthetic mesh
- Chemically cross-linked biologic grafts
- Non-crosslinked biologic grafts
Synthetic mesh materials include non-absorbable polypropylene and absorbable polyglactin. Biologic graft materials are derived from pig skin or tissue, human skin, or cattle tissue.
After reviewing scientific literature, Cook believes the body responds differently to each of the various materials.
Cook reviewed scientific literature from January 1, 1996 through August 2, 2011 on POP repair, paying close attention to the effects of different types of materials. The review found:
- Non-absorbable synthetic mesh products are permanent and may possibly create a “foreign body response,” which causes the body to reject the synthetic mesh. This causes a high rate of erosion (10%) and the potential need to have the mesh removed.
- Non-crosslinked biologic grafts have a lower average erosion rate (1.2%) than non-absorbable synthetic mesh products. Non-crosslinked biologic grafts also have an acceptably low objective prolapse recurrence rate in comparison to non-absorbable synthetic mesh (14.5% vs. 8.2%). Non-crosslinked biologic grafts bind with the natural human tissue, reducing the risk of foreign body response.
- While absorbable synthetic mesh materials have not been extensively studied and are not widely used in clinical POP repair, research suggests they do not provide long-term support to the abdominal organs and the material weakens over time. Absorbable synthetic mesh also has higher rates of recurrence. On the other hand, it has the lowest rate of erosion.
- Cross-linked biologic grafts are prone to inflammation, which creates a foreign body reaction similar to synthetic mesh, causing a high-rate of erosion. It also has high rates of pain and objective recurrence, which are higher than non-absorbable mesh products.
In reference to the reviewed literature, the Cook letter states:
“Cook’s review shows that the literature suggests that important differences exist between biomaterials 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 Non-Crosslinked Biologic Mesh
The following non-crosslinked biologic mesh products have been manufactured by Cook:
- Cook Biodesign® Surgisis® Anterior
- Posterior Pelvic Floor Grafts
- Biodesign® Surgisis® 4-Layer Tissue Graft
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