Tainted and Infected Tissue
Breaking News: April 18, 2007
Acting in the best interest of public safety, the Food and Drug Administration took possession of all implantable medical devices from Shelhigh, Inc. on April 18, 2007. Investigators from the FDA discovered serious problems with production processes such as improper sterilization and extension of expiration dates past their appropriate deadlines at Shelhigh's Union, New Jersey plant. Some of the devices affected by this FDA Preliminary Public Health Notification include:
- Shelhigh BioRing™ (annuloplasty ring)
- Shelhigh Gold™ perforated patches
- Shelhigh Internal Mammary Artery
- Shelhigh No-React® Dura Shield
- Shelhigh No-React® EnCuff Patch
- Shelhigh No-React® Pericardial Patch
- Shelhigh No-React® PneumoPledgets
- Shelhigh No-React® VascuPatch
- Shelhigh No-React® Stentless Valve Conduit
- Shelhigh No-React® Tissue Repair Patch/UroPatch™
- Shelhigh Pericardial Patch
- Shelhigh Pre Curved Aortic Patch (Open)
- Shelhigh Pulmonic Valve Conduit No-React® Treated
- Shelhigh BioConduit™ stentless valve
- Shelhigh BioMitral™ tricuspid valve
- Shelhigh Injectable Pulmonic Valve System
- Shelhigh MitroFast® Mitral Valve Repair System
- Shelhigh NR2000 SemiStented™ aortic tricuspid valve
- Shelhigh NR900A tricuspid valve
The FDA recommends that if you use any of these products that you consult your doctor immediately to determine what is the appropriate medical course of action.
If you have been the recipient of a tissue transplant, you assume that the tissue has been checked and cleared and is, therefore, not tainted and infected. You put your faith in the medical professionals assisting you, and you hope for the best outcome possible.
Unfortunately, sometimes the worst happens, especially when tainted and infected tissue is used by the surgeon during the transplant.
It's a horrible thought that tainted and infected tissue might be on the market. After all, we're living in the 21st century, in the age of technology and information. How could tainted and infected tissue be available?
Ironically, the human need for greed sometimes raises its head. Corners are cut and procedures are not fully performed. Tainted and infected tissues may be used for donations of eyes, muscles, and skin, unbeknownst to the physician performing the surgery and the patient receiving the tainted and infected tissue. It's only after the surgery that complications rear their heads.
Sometimes, a patient is diagnosed with a disease, such as HIV/AIDS or hepatitis, that he or she did not have in his or her preoperative days. After a medical inspection or investigation, it is discovered that tainted and infected tissue was used during the consumer's medical procedure, thus resulting in contractingf a potentially fatal disease.
Other adverse side effects to being given tainted and infected tissue may include blood problems, heart problems, and, of course, long and painful hospital stays.
Though most tissue used during operations is "clean", there are many "tissue brokers" who sell tainted and infected tissue to hospitals. Though the hospitals may not be aware that they are using tainted and infected tissue, they are could be just as responsible as the "tissue brokers" for ensuring the safety of the patient.
Don't delay - contact our office by telephone or email to find out how you can get the monetary compensation you deserve as a result of the suffering you incurred.
By filing a claim or joining a class action lawsuit, you'll also be telling the medical industry that consumers will not take negligence with a "wait and see" attitude. Call us today to schedule a no-obligation consultation with one of our team of legal experts.