Shelhigh Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices

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Shelhigh, Inc. Rips FDA’s Decision to Seize Products
The FDA announced recently that they were seizing all of the implantable devices being made and distributed by Shelhigh, Inc. a major player in the implantable pediatric heart device field.  The seizure was announced after the FDA completed a full inspection of the plant and had several meetings with the company in regards to the plethora of problems that the FDA believed it had discovered during this process.

The biggest problems with Shelhigh’s products, according to the FDA, was the sterility, or lack thereof, of the plant and the resulting products.  This would be a particularly serious problem for those patients who receive the products, as they’re typically used on children who are either born with or later develop serious heart problems.

The presence of impurities anywhere near this tender zone within the heart valves could cause immediate and irreparable harm to the patient, and in some cases could lead to infections that lead to the death of these patients if the impurities are prevalent enough and aggressive enough to ravage the system inside the child.

Shelhigh Cries Foul

The FDA announced its decision to seize these products through a press release and through a posting on its Web site (http://www.medicalnewstoday.com/articles/68664.php), and Shelhigh responded aggressively and quite vociferously.  Below are a few quotes from Shelhigh founder and Chief Scientific Officer, Shlomo Gabbay, M.D., as they appeared on the Web site of Medical News Today

“During this inspection Shelhigh fully addressed all observations raised by FDA personnel, repeatedly requested corrections of statements made by the FDA in their site report, and also repeatedly requested meetings with the FDA to discuss any outstanding issues as well as concerns which arose during the 10 week inspection, and these meetings were also refused by the FDA.”

“It is unfortunate that the FDA is stopping Shelhigh from shipping our life-saving products, and I remain hopeful that the FDA will quickly resolve whatever internal issues they have which have lead to their baffling seizure decision,” said Dr. Gabbay.
As a result of this decision and subsequent action, Shelhigh intends to file a lawsuit against the FDA in federal court in order to regain the right to manufacture and distribute the products in question. 

Your Next Step

If your child has had one of Shelhigh’s implantable heart valve products used in a heart procedure, seek immediate medical attention to make sure that nothing is wrong.  If it turns out that there is a problem because of a Shelhigh product, contact a defective medical device attorney immediately to begin the process of analyzing your legal rights.

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Shelhigh Heart Valves and Valve Conduits FDA Seizure Page updated on 3/06/2013