On April 17, 2007, U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals seized all implantable medical devices from Shelhigh, Inc., of Union, N.J., after finding significant deficiencies in the company's manufacturing processes, including finding that medical devices manufactured by Shelhigh, Inc. were manufactured under conditions that may have contaminated the devices. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

The defective products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

All medical device companies must follow current good manufacturing practice, a set of requirements that help to ensure the safety and effectiveness of all medical products. Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.

The FDA recommends that physicians "use alternative devices" and "monitor patients with a Shelhigh device for infections and proper device functioning over the expected lifetime of the device." They also recommend that patients who "may have received a Shelhigh device during surgery "contact their physician".

The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action. FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters.

Medical devices manufactured by Shelhigh include:

• Shelhigh Pericardial Patch
• Shelhigh No-React Pericardial Patch
• Shelhigh No-React PneumoPledgets
• Shelhigh No-React VascuPatch
• Shelhigh No-React Tissue Repair Patch/UroPatch
• Shelhigh Pulmonic Valve Conduit No-React Treated
• Shelhigh No-React Dura Shield
• Shelhigh BioRing (annuloplasty ring)
• Shelhigh No-React EnCuff Patch
• Shelhigh No-React Stentless Valve Conduit
• Shelhigh Internal Mammary Artery
• Shelhigh Gold perforated patches
• Shelhigh Pre Curved Aortic Patch (Open)
• Shelhigh NR2000 SemiStented aortic tricuspid valve
• Shelhigh BioConduit stentless valve
• Shelhigh NR900A tricuspid valve
• Shelhigh MitroFast Mitral Valve Repair System
• Shelhigh BioMitral tricuspid valve
• Shelhigh Injectable Pulmonic Valve System

To identify a device manufactured by Shelhigh, Inc., we recommend that you first check for the company's name and address, which we believe are consistently displayed on the device packaging. Below are some brand names known by FDA of medical devices manufactured by Shelhigh, Inc., including those made for another company and those that have not been cleared/approved by FDA:

FDA medical device Public Health Notifications are available on line at www.fda.gov.

The defective product lawyers at Hannon & Boyers have successfully litigated many cases where a dangerous or defective medical device has resulted in the death or serious injury of a patient, consumer or product user.

If you or a loved one may have received a medical device manufactured by Shelhigh during surgery in Florida, please contact a Florida defective product lawyer at Hannon & Boyers for a free consultation today.

The experienced defective product lawyers at Hannon & Boyers are available to discuss your potential Shelhigh lawsuit free of charge and with no obligation. Please feel free to e-mail us at mail@hannonboyers.com or call us at (800) 545-9100.