Cohera Medical said it completed a series of mastectomies in Germany using its TissuGlu surgical adhesive, which the medical device company hopes will eventually eliminate the need for drain placement and ease the healing process for patients who have their breast tissue removed.
The news comes on the same day that actress and U.N. envoy Angelina Jolie wrote an op-ed for the New York Times of her decision to undergo a double mastectomy as a preventive measure after discovering that she carries the BRCA1 gene. The revelation has dramatically increased interest around the globe about mastectomies.
Pittsburgh, Pa.-based Cohera said in a prepared release that eliminating surgical drains during mastectomy recovery increases patient comfort and eases the healing process.
"The surgical drains must be attended to properly and can become blocked by fluid at the surgical site. Left untreated, this accumulation may cause infection and/or delayed healing," according to the release.
In her op-ed, which detailed the procedure, Jolie described how drain tubes are used in the mastectomy procedure.
"Two weeks later I had the major surgery, where the breast tissue is removed and temporary fillers are put in place," she wrote. "The operation can take 8 hours. You wake up with drain tubes and expanders in your breasts. It does feel like a scene out of a science-fiction film. But days after surgery you can be back to a normal life."
Cohera won CE Mark approval for the TissuGlu sealant in September 2011 and completed an earlier, no-drain study of 30 patients in Germany in July 2012.
The company recently landed the 1st of 4 FDA approvals for the adhesive system, which is used as an internal adhesive in large flap procedures, such as "tummy-tuck" surgery.