Alert for those with medical devices

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Preliminary Advice for Patients*

 

Preliminary Advice for Patients*: Possible Contamination and Malfunction of

Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and

Other Medical Devices Manufactured by Shelhigh, Inc.

 

 

This is an archived document. FDA has updated this document, based on

information obtained during seizure. The updated document can be found at

http://www.fda. gov/cdrh/ medicaldevicesaf ety/atp/041907- shelhigh. html

Issued: April 18, 2007

 

FDA has seized all implantable medical devices manufactured by Shelhigh, Inc.,

Union, NJ, because they were manufactured under conditions that may have

contaminated the devices. Therefore, these devices may fail to properly

function. FDA is providing the following information for patients and their

families, so they will be better able to discuss the best course of action with

their doctors. We will update this advice if necessary as more information

becomes available.

 

Patients should understand that an FDA seizure means that the existing devices

at the company will not be introduced into the market, but it does not

necessarily mean that the device needs to be removed from the patient. Seizure

is meant to stop further distribution of a product.

 

Shelhigh, Inc. devices may have been implanted during various surgical

procedures, including open-heart surgery for valve replacement; and repair of

soft tissue structures during abdominal, pelvic, heart, lung, brain, shoulder,

and spine surgery. Patients who are vulnerable to infection and are at greatest

risk for unexpected complications from the use of these devices include: the

critically ill, children, the elderly, and pregnant women.

 

The number of these devices that may be contaminated or experience problems

isn’t known at this time. These devices have been available since 1997. Problems

with the device could occur at anytime, and may become apparent to you and your

physician during routine examination. Physicians have been notified of the

problems associated with these medical devices.

 

Advice for Patients

If you don’t know if you have one of the devices in question, contact the doctor

who performed your surgery.

If you know you have one of the devices in question, you should:

Contact your doctor promptly

Follow your doctor’s instructions on care after surgery

Do not miss any follow-up appointments with your physician

Contact your physician if you have ANY signs of infection, such as

Fever

Unusual pain, swelling, redness, and warmth in the area of your implant

Drainage or discharge from the incision used during the procedure to implant the

device

 

Inform all your doctors about your surgery and that you may have a Shelhigh

device implanted.

 

You may also contact FDA’s Division of Small Manufacturers, International and

Consumer Assistance at 1-800-638-2041. For consumer information, select #2, or

to speak with a Medical Device Specialist, select #4.

Information on this topic for healthcare providers can be found at:

http://www.fda. gov/cdrh/ safety/041807- shelhigh. html

 

Information for the public can be found at: http://www.fda. gov/bbs/topics/

NEWS/2007/ NEW01612. html

 

* CDRH Preliminary Advice for Patients is intended to quickly share

device-related safety information with the public when the available information

and our understanding of an issue are still evolving. We will revise them as new

information merits and so encourage you to check this site for updates.

Updated April 18, 2007

 

 

 

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