AccessMyLibrary provides FREE access to over 30 million articles from top publications available through your library.
Create a link to this page
Copy and paste this link tag into your Web page or blog:
Counterfeit surgical mesh reaches the U.S. market: how to spot the sham version.(News)
A counterfeit version of Prolene nonabsorbable surgical mesh has been found on the market, according to Ethicon Inc., the manufacturer of the authentic product.
In a "Dear Healthcare Professional" letter posted on the Food and Drug Administration's Medwatch Web site, Ethicon described features that can help distinguish the authentic mesh from the counterfeit version. The sham product has been found only in the United States.
Prolene is a nonabsorbable polypropylene mesh product used in the repair of hernias and other fascial deficiencies when reinforcing or bridging material is needed to obtain the desired surgical result.
The counterfeit product is labeled as Prolene polypropylene mesh and has a product code of PMII, with lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07). it is a flat mesh product, measuring 3 inches by 6 inches.
The Ethicon logo is ...
- Surgical mesh maker issues warning about counterfeit product: prolene...
- Magazine article from: Skin & Allergy News Mechcatie, Elizabeth February 1, 2004 700+ words
A counterfeit version of Prolene nonabsorbable surgical mesh has been found on the...authentic mesh from the counterfeit version. The sham product has...not cut cleanly on the counterfeit version, but is smooth on the...
- TyRx Announces FDA 510(k) Filing for New Antibiotic Eluting Surgical Mesh.
- Press release article from: PR Newswire January 17, 2006 700+ words
Surgical Mesh is designed to improve patient comfort and reduce...Administration (FDA) for its novel antimicrobial surgical mesh product. TyRx expects to launch this new surgical mesh in Q1-06. This is the second in a series of combination...
- TyRx Pharma's Anesthetic Coated Surgical Mesh Combination Product Assigned to...
- Press release article from: PR Newswire January 9, 2006 700+ words
...announced today that its Anesthetic Coated Surgical Mesh has received a designation of "Combination...study design for the Anesthetic Coated Surgical Mesh. TyRx plans to initiate clinical trials...safety of TyRx's Anesthetic Coated Surgical Mesh combination product in patients ...
- Generic Medical Devices Receives FDA 510(k) Clearance for Universal Surgical...
- Press release article from: Business Wire May 9, 2007 700+ words
...FDA) has cleared the GMD Universal Surgical Mesh for market. This marks the company...products. The availability of the Surgical Mesh will provide hospitals, ambulatory...Medical Devices. "With the Universal Surgical Mesh, GMD has furthered its goal of providing...
- TyRx Announces FDA 510(k) Clearance for New Surgical Mesh.
- Press release article from: Business Wire January 3, 2006 700+ words
...its new bioresorbable polymer coated surgical mesh product. TyRx expects to launch this new surgical mesh in Q1-06. This is the first in a...year. The TyRx bioresorbable polymer surgical mesh is indicated for the repair of hernias...
- FDA clears surgical mesh with polymer coating.(Food & Drug Administration,...
- Magazine article from: Plastics Engineering Molinaro, Hope March 1, 2006 700+ words
...new bioresorbable polymer-coated surgical mesh product for the repair of hernias and...the FDA for a second polymer-coated surgical mesh product for reinforcement as above...implantation from colonization of the surgical mesh by the most common sources of surgical...
- TyRx Announces FDA 510(k) Filing for New Surgical Mesh.
- Press release article from: PR Newswire October 17, 2005 700+ words
...new bioresorbable polymer coated surgical mesh product on Friday, October 7th. The TyRx bioresorbable polymer surgical mesh is indicated for the repair of...creating milestone with our new surgical mesh," said Bill Edelman, CEO of...
- Anulex Technologies Receives FDA 510(k) Clearance for the Inclose(TM) Surgical...
- Press release article from: Business Wire August 22, 2005 700+ words
...k) clearance of its Inclose(TM) Surgical Mesh System. The Inclose(TM) Surgical Mesh System is a novel, patented implant that...facilitate the repair of soft tissue. The surgical mesh implant is comprised of polyethylene terephthalate...
Source: HighBeam Research, Counterfeit surgical mesh reaches the U.S. market: how to spot the...