FDA’s inspections of Shelhigh, Inc., a New Jersey medical device manufacturer, revealed improper sterilization and extension of the expiration dates for the firm’s medical devices. The conditions were bad enough that the FDA seized all the medical devices at the Union, N.J. plant. Although a milion products were seized, countless Shelhigh devices have been implanted into patients. These products could be contaminated (which could cause fatal infection) or could malfunction. The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid 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 and to repair tissue during surgery.
The FDA is recommmending that surgical patients contact their physicians if they have ANY signs of fever, unusual pain, swelling, redness, and warmth in the area of the implant, or drainage or discharge from the incision site. The FDA has notified public health officials of the possible contamination and malfunction of Selhigh heart valves and other devices. FDA recommends that physicians attempt to identify all Shelhigh devices that may have been implanted into their patients by checking the packaging from each device used in implant surgical procedures. The FDA provided a complete list of possibly contaminated and/or defective Shelhigh medical devices.</u> The introduction of endotoxins into a patient during surgery from bacterial
contamination from non-sterile implantable devices could lead to such conditions as Severe Inflammatory Response Syndrome, a potentially fatal condition that effects the organs.
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