Everyone values their health. We cannot place a value on our health and safety. When Americans place their health in the hands of a surgeon they expect to receive the best of treatment. A patient sincerely hopes that all factors related to medicine will have the highest of standards. Safety must be first.
To keep with the highest safety requirements, the FDA has seized medical devices due to risk to patients. A Union, New Jersey facility has been found to have medical devices that do not meet medical standards. Concerns are in regards to the sterility of the medical devices.
Shelhigh, Inc. manufactures implants for surgical procedures such as open-heart surgery. Other devices involved in the issue include soft-tissue patches involved in neurosurgery. Implants for abdominal and pelvic surgical procedures are suspect, as well. Their products are available for use for both adults and children. As many as 19 items have been seized and recalled.
Doctors have been warned to use other products to avoid risk to patients. Adults and children who may have received one of the devices manufactured by Shelhigh, Inc. are urged to call their doctor for advice. Patients who have one of the Shelhigh products should be monitored for infection. Also, doctors should be certain to check for effectiveness of the Shelhigh product for the duration of the product's life. More information about the products will be released and available on the FDA website.
On April 17, 2017 officials from the FDA seized the medical devices due to concerns about the manufacturing process of such devices at the Shelhigh, Inc. facility. Based on inspection information discovered in the fall of 2016, the facility was not following the appropriate safety guidelines. Shelhigh, Inc. was not properly monitoring the cleanliness of areas where such items were manufactured. Expiration dates on the products may be inaccurate. Shelhigh, Inc. did not properly back up the expiration dates of such products with scientific data.
Patients with immune deficiencies are at the greatest risk of developing complications from Shelhigh, Inc. products. Pediatric patients are also susceptible to this safety risk.
Shelhigh, Inc. was contacted about concerns related to inspections last fall. The FDA brought to the attention of Shelhigh, Inc. the numerous violations of proper manufacturing procedure for medical devices. Two letters were sent to Shelhigh, Inc. forewarning the facility of the actions to be taken should the proper measures to remedy the violations not be implemented.