Shelhigh Medical Device Manufacturer-Under the Gun-FDA Claims of Repeated Problems
Many of us remember the TV Shows The Six Million Dollar Man and The Bionic Woman, but most of us had no idea how close we would come to rebuilding our human bodies in the 21st century. Inventions and advances in medical technology have given so many a 'second chance' at life.
But, many times there may be a price to pay, as in the case of Shelhigh. Shelhigh is known for producing some of the best and most lauded medical devices available for the last ten years, but problems with repeated contamination at Shelhigh's single facility in Union, NJ not only caused a recent FDA 'recall' but these continued contaminations during the manufacturing process have potentially put at risk those patients who have been implanted with Shelhigh devices.
Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.
Shelhigh is well-known for its No-React tissue poducts which were developed for the express purpose of resisting infection. Unfortunately, even if the product was well-developed, the fact that it has been manufactured in a physical environment that itself was contaminated is not only counterproductive to Shelhigh, but dangerous to those who have trusted this company with their very lives.
Who is at risk? Because infection can best breed in those who are already compromised, critically ill patients, pediatric patients, and those with other diagnosed immuno-compromising illness' are most at risk, because their bodies are unable to fight off the most innocuous infections.
Shelhigh's medical devices include pediatric heart valves and conduits, which are tube-like devices used for blood flow; surgical patches; dural patches; nnuloplasty rings and arterial grafts.
The following is a list of Shelhigh products:
BioRingT (annuloplasty ring)
GoldT perforated patches
Internal Mammary Artery
No-React Dura Shield
No-React EnCuff Patch
No-React Pericardial Patch
No-React Pneumopledgets
No-React VascuPatch
No-React Stentless Valve Conduit
No-React Tissue Repair Patch/UroPatchT
Pericardial Patch
Pre Curved Aortic Patch (Open)
Pulmonic Valve Conduit No-React Treated
BioConduitT stentless valve
BioMitralT Tricuspid valve
Injectable Pulmonic Valve System
MitroFast Mitral Valve Repair System
NR2000 SemiStentedT aortic tricuspid valve
If you are a patient who may have received one of these devices:
1. Contact the surgeon who performed your surgery and have your records checked to see if one of the affected devices was, in fact, implanted.
2. If you already know that you have one of the affected devices, then contact your doctor promptly.
3. If your doctor gave you after-care instructions when you left the hospital, be sure to strictly adhere to those instructions.
4. Be certain to contact your surgeon or family doctor if any signs of infection are present. Signs include, but are not limited to:
a. Fever
b. Unusual pain, swelling, redness, and warmth in the area of your implant
c. Drainage or discharge from the incision used during the procedure to implant the device
As a patient, please understand that the seizure of Shelhigh medical devices only means that the existing devices at the company will not be introduced into the market until and when the FDA determines that sanitary conditions within the manufacturing plant have been remedied. While some types of contamination may affect the life of the medical device, it does not necessarily mean that your device will need to be removed. Seizure is meant to stop further distribution of a product until safety standards are met.
Finally, be certain to notify all of your doctors that you might have a Shelhigh implant that falls within the 'recalled' group.
As we see personal rights, individuals' access to the courts and corporate accountability being eroded by ro-business and anti-consumer legislation and rule making by our present lawmakers, we are seeing corporate America becoming more and more brazen in dealing with federal agencies. Corporate America feels that they can get away with most things these days, that the federal regulatory agencies do not have much power and that those agencies certainly are not backed up by the White House. This feeling manifests itself in corporations like Shelhigh defying the FDA.
But, many times there may be a price to pay, as in the case of Shelhigh. Shelhigh is known for producing some of the best and most lauded medical devices available for the last ten years, but problems with repeated contamination at Shelhigh's single facility in Union, NJ not only caused a recent FDA 'recall' but these continued contaminations during the manufacturing process have potentially put at risk those patients who have been implanted with Shelhigh devices.
Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.
Shelhigh is well-known for its No-React tissue poducts which were developed for the express purpose of resisting infection. Unfortunately, even if the product was well-developed, the fact that it has been manufactured in a physical environment that itself was contaminated is not only counterproductive to Shelhigh, but dangerous to those who have trusted this company with their very lives.
Who is at risk? Because infection can best breed in those who are already compromised, critically ill patients, pediatric patients, and those with other diagnosed immuno-compromising illness' are most at risk, because their bodies are unable to fight off the most innocuous infections.
Shelhigh's medical devices include pediatric heart valves and conduits, which are tube-like devices used for blood flow; surgical patches; dural patches; nnuloplasty rings and arterial grafts.
The following is a list of Shelhigh products:
BioRingT (annuloplasty ring)
GoldT perforated patches
Internal Mammary Artery
No-React Dura Shield
No-React EnCuff Patch
No-React Pericardial Patch
No-React Pneumopledgets
No-React VascuPatch
No-React Stentless Valve Conduit
No-React Tissue Repair Patch/UroPatchT
Pericardial Patch
Pre Curved Aortic Patch (Open)
Pulmonic Valve Conduit No-React Treated
BioConduitT stentless valve
BioMitralT Tricuspid valve
Injectable Pulmonic Valve System
MitroFast Mitral Valve Repair System
NR2000 SemiStentedT aortic tricuspid valve
If you are a patient who may have received one of these devices:
1. Contact the surgeon who performed your surgery and have your records checked to see if one of the affected devices was, in fact, implanted.
2. If you already know that you have one of the affected devices, then contact your doctor promptly.
3. If your doctor gave you after-care instructions when you left the hospital, be sure to strictly adhere to those instructions.
4. Be certain to contact your surgeon or family doctor if any signs of infection are present. Signs include, but are not limited to:
a. Fever
b. Unusual pain, swelling, redness, and warmth in the area of your implant
c. Drainage or discharge from the incision used during the procedure to implant the device
As a patient, please understand that the seizure of Shelhigh medical devices only means that the existing devices at the company will not be introduced into the market until and when the FDA determines that sanitary conditions within the manufacturing plant have been remedied. While some types of contamination may affect the life of the medical device, it does not necessarily mean that your device will need to be removed. Seizure is meant to stop further distribution of a product until safety standards are met.
Finally, be certain to notify all of your doctors that you might have a Shelhigh implant that falls within the 'recalled' group.
As we see personal rights, individuals' access to the courts and corporate accountability being eroded by ro-business and anti-consumer legislation and rule making by our present lawmakers, we are seeing corporate America becoming more and more brazen in dealing with federal agencies. Corporate America feels that they can get away with most things these days, that the federal regulatory agencies do not have much power and that those agencies certainly are not backed up by the White House. This feeling manifests itself in corporations like Shelhigh defying the FDA.
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