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Shelhigh Medical Device

On May 2, 2007, the U.S. Food and Drug Administration (FDA) issued a notification to the public that it was requesting a recall from Shelhigh, Inc. of all its medical devices from the marketplace, including hospital inventories. The reason for the request was that there were sterility concerns with respect to its devices.

On April 17, 2007, FDA investigators and U.S. Marshals seized all implantable medical devices from Shelhigh after discovering critical problems with the company's manufacturing process. The products included a wide range of implantable devices, such as:

  • Pediatric heart valves and conduits, which are tube-like devices for blood flow
  • Surgical patches
  • Dural patches, which help in tissue recovery after neurosurgery
  • Annuloplasty rings, which aid in the repair of the heart valves, and arterial grafts

Many of these devices are used for seriously-ill patients, such as open heart surgery for adults, children, and infants, and repairing soft tissue during neurosurgery. Because of the lack of sterility of the medical devices, patients who have been implanted with Shelhigh devices are at heightened risk of worsening health. To see a list of Shelhigh devices that the FDA has not approved of, please click on this link.

Shelhigh's Violations

Shelhigh has violated many approved manufacturing practices that ensure the safety of medical products. The violations include the following:

  • Developing products in a facility that has a room, where sterilized devices are processed, that is not properly maintained and cleaned
  • Failing to monitor the environment for microbial contamination
  • Failing to test products to make sure they are sterile
  • Failing to scientifically support product expiration dates.

FDA's Recommendations

The FDA makes several recommendations to protect the health of patients who have used or been implanted with Shelhigh devices:

  • Doctors should use alternative devices.
  • Doctors should monitor patients who have had Shelhigh devices implanted for possible infections or problems. Doctors should also monitor patients over the long-term to ensure that the devices are working properly over the expected lifetime of the device.
  • Contact your doctor if you are unsure of whether you have been implanted with a Shelhigh device.
  • If you know you have been implanted with a Shelhigh device, you should contact your doctor right away, follow your doctor's instructions after surgery, do not miss follow-up appointments with your doctor, and contact your doctor if you have any signs of infection, such as fever, swelling or pain around the implant, or drainage from the incision site.

To see the FDA's Questions & Answers page on Shelhigh Medical Devices, click this link.

When devices are not sterile but implanted anyway, a patient faces severe health risks. If you or someone you care about has had a Shelhigh device implanted in them, and it has resulted in health complications or injuries, contact an experienced attorney, who can ensure that you are justly compensated for the harm you have suffered, at Anderson Law Offices, LLC.

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