800.965.1461
415.568.2556
415.568.2555
Shelhigh Medical Device FDA Seizure:
If you were implanted with ANY medical device from Shelhigh, Inc. and later suffered any serious side effect, you may be entitled to compensation. Contact us now to speak to an attorney (your privacy is assured).
FDA PRESS RELEASE:
FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations
U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals . . . seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.
The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.
All medical device companies must follow current good manufacturing practice, a set of requirements that help to ensure the safety and effectiveness of all medical products. 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.
Physicians should consider using alternative devices. Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. FDA will issue a Preliminary Public Health Notification to physicians and other health care professionals and a Preliminary Advice for Patients shortly with more information; those documents will be posted to FDA's Web site.
The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action. FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters.
Medical devices manufactured by Shelhigh include:
- Shelhigh Pericardial Patch
- Shelhigh No-React Pericardial Patch
- Shelhigh No-React PneumoPledgets
- Shelhigh No-React VascuPatch
- Shelhigh No-React Tissue Repair Patch/UroPatch
- Shelhigh Pulmonic Valve Conduit No-React Treated
- Shelhigh No-React Dura Shield
- Shelhigh BioRing (annuloplasty ring)
- Shelhigh No-React EnCuff Patch
- Shelhigh No-React Stentless Valve Conduit
- Shelhigh Internal Mammary Artery
- Shelhigh Gold perforated patches
- Shelhigh Pre Curved Aortic Patch (Open)
- Shelhigh NR2000 SemiStented aortic tricuspid valve
- Shelhigh BioConduit stentless valve
- Shelhigh NR900A tricuspid valve
- Shelhigh MitroFast Mitral Valve Repair System
- Shelhigh BioMitral tricuspid valve
- Shelhigh Injectable Pulmonic Valve System
### END OF FDA ARTICLE ### [emphasis added]
UPDATE APRIL 24, 2007: SHELHIGH'S LAWYERS THREATEN AUDET & PARTNERS WITH LEGAL ACTION FOR CONTENT OF THIS WEBSITE.
Shelhigh's legal team has threatened Audet & Partners, LLP with legal action over the content on this webpage. Ironically, the only "content" on this webpage is an FDA "press release," which we simply repinted verbatim.
Here is the FDA Complaint.
Needless to say, we have declined Shelhigh's request that we change our website to conform to their whims.
Here is the original demand letter from attorney Larry R. Pilot, an attorney with the law firm of McKenna Long & Aldridge LLP, in Washington, D.C.:
Here is our response, in which we decline their request that we change our website:
Here is their response to our response:
If you think that you may have been harmed by ANY medical device from Shelhigh, Inc., you are strongly encouraged to contact us now. There is no charge and no obligation. If we take your case, there is no fee for our services unless we win your case or settle it in your favor.
On the other hand, if you fail to protect your legal rights now, you may lose the right to be compensated for your harm. (Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred.)
Our firm has a great deal of experience in representing plaintiffs in “medical device ” cases, and in fact is currently pursuing numerous cases against makers of similar devices.
In addition, we have the resources to handle our own cases. This means that when you call our firm, you talk to your own lawyer who has been assigned to your own case.
Please contact us now. The secure form only takes a couple of minutes to fill out, but if you are uncomfortable sending your information over the internet, please call our toll-free number at 800.965.1461 to immediately speak to an attorney. The call is free and there is no obligation. Act now, as delays can harm your case.
