A groundbreaking UK study of medical devices used in breast surgery called iBRA (www.ibrastudy.com) was recently established. This intensive analysis of both aesthetic and reconstructive surgeries, led in part by Dr Sigi Refsum of Belfast City Hospital, compared and contrasted patient outcomes. The study has proved to be particularly timely as media attention on Angelina Jolie has proved to have patient impact on risk-reducing genetic cancer prevention.
At the London Breast Meeting in September, a group of UK oncology and breast surgeons, as well as plastic surgeons who reconstruct the breast, formed a coalition of nine hospital centres to compare best practices. Known as iBRA (http://ibrastudy.com/) the collaboration will also “evaluate clinical and patient outcomes of implant-based reconstruction.” For the first time, this clinical study will include both acellular dermal (animal skin) matrix and polymer-based resorbable mesh.
One important factor will be examining infection rates in breast surgery and how polymer-based synthetic suturing or mesh products can reduce, or eliminate, the incidence.
A major trend also impacting medical plastics demand and breast remodelling surgeries comes from Angelina Jolie’s decision to have a preventative mastectomy. There has been a huge influx of patient inquiries about risk-reducing surgery for those with the BRCA 1 genetic marker for cancer as well as family history. Using surgical matrix mesh to scaffold, support and offer natural tissue regeneration can make the reconstruction easier to select.
“Implant-based reconstruction is now the standard,” said Dr Sigi Refsum, surgical team leader at Belfast (Ireland) City Hospital and one of the first medical centres to engage in the iBRA study. “Implants are quick, allow a shorter recovery period, have a better shape and allow us to do surgical scaffolding using both synthetic and biologic materials to close.”
A new matrix mesh which resorbs based on natural tissue regeneration called TIGR will now be included in the iBRA metrics. “We find TIGR has a lower instance of redness, a lower cost advantage for the patient and has an added benefit of letting surgeons like me add to tissue coverage in unexpected situations,” said Dr Refsum.
TIGR Matrix is a polymer-based mesh that is knitted into a fabric-like material and is softer, more flexible and has two layers of absorption. This includes an ability to resorb over three months for breast surgery patients and a second layer which lasts about six months before being eliminated. It is only possible because of polymer chemistry. Novus Scientific settled on a fibre from the lactide polymer family blended with trimethylene carbonate to increase the elasticity of the fibre and resorption.
Lactide and glycol polymers have been in clinical use since the early 1970s. They are simply polyesters degrading with the help of water into simple metabolites already present in our body.
Stefan Sowa is director of operations for Novus Scientific which has developed the latest innovation in polymer-based surgical mesh.
“TIGR Matrix surgical mesh is made from a fast-degrading material, the same material found in Vicryl, Dexon and Maxon,” said Sowa. The polymer has been used for 40 years for suturing, and is comprised of a slow degrading material base on a higher content of poly-lactide.
“The knitted mesh consist of more than 15 fibre strands and each fibre alone has more than 80 individual filaments of the two different materials knitted into the unique design,” he added. There is high porosity to allow for good integration of new tissue and thus healing. The fast-degrading fibre disappears quickly to allow Mother Nature to take over,” said Sowa, and are therefore backed-up by the more slow degrading fibre providing support until the collagen tissues are ready to fully take over the load.”
Surgical mesh like TIGR can be “overlaid over the entire breast area so I don’t have to cut as much or as accurately, so initial results are promising,” Dr Refsum added. “We want to study this so-called ‘biosynthetic’ plastic mesh with the permanent synthetics, human cadaver or animal products out there.”
According to leading breast and oncology surgeons, bilateral mastectomy or prophylactic work with implants can permit reconstruction in about 90% of women with breast cancer. While implants cannot cure cancer, in over 50% of those cases where surgery is completed for those with genetic markers, it does prevent women from contracting breast cancer. Still, it’s encouraging that these mastectomies bring the risk down to levels of the general population.
Dr. Refsum, who is the clinical team leader of Belfast City, said Jolie had, “brought breast cancer prevention to the forefront and raised awareness.” She said many patients across the UK are seeking the genetic testing.
Mike Smith (twitter smittypa) is a Washington-based journalist. He reports for Huffington Post, Topix and many trade industry journals. He began his career in communications at Dow Chemical Company in Midland, Michigan.