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Biologics needleSoft tissue is a crucial component of the human body that serves to connect, support, or surround other structures. Seeing as the main component of soft tissue, collagen, is the most abundant protein in mammals, it is of utmost importance that this tissue remains healthy. Complications with soft tissue can result in a myriad of medical conditions that often can only be treated successfully via surgical intervention.

Controversy Surrounding Synthetic Mesh Grafts
Historically, soft tissue related ailments were often treated using native grafts from the patient’s own body. This autologous grafting still plays an important role in the treatment of soft tissue, but it does have its limitations. Since the tissue must be harvested from somewhere else on the patient’s body, often there simply isn’t enough tissue available to remedy more severe conditions. This technique also results in increased scarring and adds valuable time to the surgical procedure.

A surgical method of treatment that offers an alternative to autologous grafting is the use of manufactured grafts composed of synthetic materials. These alloplasts became popular in the last few decades, as they provided a treatment option that sped up rehabilitation by avoiding the harvest site morbidity associated with autologous grafting.

The downside to these synthetic mesh grafts is that unlike grafts sourced from the patient’s own native tissue, the implantation sometimes elicits a foreign body reaction which can lead to the grafts being rejected by the patient’s body. This adds unnecessary costs because, in these cases, a follow up procedure to remove the synthetic graft needs to be performed. Furthermore, throughout the 2000s there were some highly publicized cases of patients being injured by the erosion of synthetic mesh in their bodies following hernia repair procedures.

At around the same time, reports surfaced of similar complications relating to the erosion of synthetic vaginal sling mesh in patients following their implantation procedures aimed at treating urinary incontinence. The FDA intervened and issued warnings related to synthetic mesh and the possible complications it can cause. These incidents resulted in severe chronic pain and infections for the affected patients and led to thousands of lawsuits against some of the larger synthetic mesh manufacturers. Many of these companies eventually quietly pulled some of their products from the market in response to the negative publicity.

 

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Originally published on Med Device Online, October 2, 2014

Author

Jesse Spicer is a research analyst at iData Research and was the lead researcher for the 2015 U.S. Soft Tissue Reinforcement and Regeneration Market Report. He was recently quoted in Reuters for his expertise in the U.S. biologics market.