MND, June 24, 2015 ~
According to ongoing research, bacterial biofilms are being studied for their role in inciting an autoimmune response in patients implanted with polypropylene mesh used to treat incontinence.
It’s long been noted that a mesh implant can cause pain, infection, organ perforation, nerve entrapment and vaginal scarring. Systemic symptoms have been noted as well and include muscle pain, arthritis, sinusitis, asthma, chronic fatigue, cognitive impairment and skin conditions.
As part of the latest ongoing research from UCLA, mesh explant segments showed chronic inflammation surrounded by bacterial colonies which were not found in patients who only suffered from mesh obstruction. That research is not yet published. Mesh News Desk will report on the findings when they become available.
One theory is that a transvaginal placement (through the vagina) of pelvic mesh leads to unavoidable contamination that may result in bacterial biofilms on the mesh in susceptible individuals. Biofilms provide a protective mechanism and can protect the bacterial colony from antibiotics. Over time, its subclinical infection may override the body’s immune system leading to long-term reaction to the pelvic and hernia mesh implant.
Biofilm formation is common on most polymeric materials and it thrives in high humidity.
Montana State and Stanford University are among the schools who have biofilm centers studying this scientific phenomenon that has been emerging over the last two decades. The University of California Los Angeles (UCLA) is focusing their studies on the occurrence of biofilms on mesh explants.
Using a new medical implant material and avoiding the transvaginal approach may minimize the risk of systemic symptoms. Unfortunately, the bulk of the 100,000 defective product lawsuits filed against seven mesh manufacturers resulted from the use of the transvaginal approach to implant a petroleum-based mesh product.
Biomaterials Access Assurance Act and Immunity for Suppliers
The Biomaterials Access Assurance Act of 1998 (BAAA) provides protections for biomaterial suppliers of implanted medical devices from product liability litigation filed in civil suits. Ironically, petroleum-based products are referred to as biomaterials and they include Dacron, Polytetrafluorethylene (Teflon) and Polypropylene.
Common law protected biomaterials suppliers (Phillips Sumika, for example) from product liability lawsuits prior to BAAA but in 1998, Congress determined the industry warranted special protections because of the potential of the multi-billion dollar market.
There is an effort underway to repeal the Biomaterials Access Assurance Act of 1998. It would hold any supplier of raw material such as liable if they knowingly supply said materials to a medical device company to manufacture an implantable medical device, unless it is necessary to save lives. See the Mesh News Desk story here.
The biomaterials market reportedly flourished after the BAAA and was predicted to be $58 billion in 2014.
But don’t look to the material supplier to assure its polymers are safe to be used in the human body.
From McDermott Law: “By performing additional testing on the product, however, biomaterials suppliers may paradoxically find themselves assuming greater legal risk, since a court could find a duty on the suppliers’ part to perform additional testing, provide more extensive disclosure or even withdraw products to avoid liability for the negligent performance of an undertaking.”
Read more on the BAAA petition here:
FDA: Implementation of the Biomaterials Access Assurance Act of 1998 here
White Paper: Assessing Protections for Biomaterials Suppliers 12 Years After the Biomaterials Access Assurance Act, November 18, 2010, McDermott Will & Emery here
Prevention of Biofilm Associated Infections and Degradation of Polymeric Materials used in Biomedical Applications, Royal Institute of Technology, Sweden, Biomedical Engineering, Trends in Materials Science, January, 2011, here
Mesh News Desk, September 22, 2013, Biofilm Protects Bacteria and Causes Chronic Infection here
The Science behind Biomaterials in Female Stress Urinary Incontinence Surgery, Jan. 2009, The Scientific World Journal
An Introduction to Microbial Biofilms May 2015, BFK Solutions LLC here
Scripps Research Institute on Biofilms and Colon Cancer May 2015 here