FDA Alert Defective Shelhigh Medical Devices
Seeger Weiss LLP is investigating claims involving products manufactured by Shelhigh, a New Jersey-based manufacturer of medical devices used in adults, children and infants. Devices manufactured by Shelhigh include heart valves, valve conduits, annuloplasty rings, dural patches and surgical patches.
In April 2007, U.S. Marshalls, at the Food and Drug Administration's (FDA) request, seized property at the Shelhigh plant. Reports indicate that the FDA has had concerns about Shelhigh's products since April 2000 and that Shelhigh refused to investigate adverse reports about its devices. The FDA recently advised patients who don't know if they have one of the devices in question to contact their surgeon and advised any patient that shows signs of infection, such as discharge, drainage, pain, fever, swelling, redness or warmth in the area of their implant to immediately contact their physician.
Sales of Shelhigh devices date back to 1997 and the FDA now says the number of defective products is not known but warns that problems "could occur at any time, and may become apparent to you and your physician during routine examination."
If you or someone you has been implanted with a defective Shelhigh medical device, please complete the free case evaluation and a attorney at Seeger Weiss LLP will contact you to discuss your legal rights.
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