The scope of the tainted body parts scandal grows wider and more disturbing each day as hospitals grapple with patients who may have received tainted tissue.
So far, 16 surgical patients here and 78 at the Jersey shore have been notified that they may have received contaminated tissue. Across the United States and Canada, the number is well into the hundreds.
Now, another group of patients who may have received tainted tissue is emerging.
Dental patients who received implants – titanium alloy pegs that replace missing teeth – from early 2004 to September 2005 also may have been given a small amount of tainted cadaver tissue to bulk up their own bone.
At least one local patient has been notified.
The Temple University School of Dentistry said an unnamed clinic patient got tissue supplied by Biomedical Tissue Services, Inc. of Fort Lee, N.J.
The company, shut down last month by the U.S. Food and Drug Administration, bought body parts from unscreened donors and without proper family consent. It sold them to five vendors who supplied hospitals and doctors.
Last month, Michael Mastromarino, owner of Biomedical; his business partner, and two tissue-recovery workers were charged by a Brooklyn grand jury with harvesting body parts without legal consent and with taking tissue from cadavers in unsanitary conditions and without proper screening for disease. All four have pleaded not guilty.
The Temple patient who received tissue has been notified, said school spokeswoman Erin Jelesiewicz.
Temple and the University of Pennsylvania, which said it did not use the suspected tissue, are the only two dental schools in the city.
However, an estimated 170 specialized dentists in Philadelphia perform dental implants, as do some 380 in the four suburban counties. In addition, periodontists use donor bone to help prevent teeth from falling out. Each office buys its own tissue supplies from a vendor.
In October, the FDA required manufacturers who did business with Biomedical to recall their product and alert their customers.
The FDA recommends health-care providers, including oral surgeons and periodontists, inform their patients who received tissue implants from the five vendors. Patients are encouraged to be tested for HIV, hepatitis B and C , and syphilis, although the FDA says the infection risk is low because the tissues were processed to kill disease.
“Any dentist that does this work knows about the recall, I am sure,” said Dr. Robert Seckinger, a Center City prosthodontist and member of the Philadelphia Dental Society board of governors. “I know that multiple letters have been sent by different manufacturers.”
Seckinger, who did not deal with any of the five vendors who bought from Biomedical, explained that a patient generally receives donor material that is the size of a pinhead. It is mixed with a patient’s own bone to anchor an implant.
Because the FDA is investigating how Biomedical acquired its body parts and which patients ultimately received this tissue, there has been little federal information on the extent of the scandal. What information is known has been gleaned from hospital statements, lawsuits, and from financial filings by the publicly traded vendor companies.
However, New Hampshire took the initiative to address the scandal. The state health department tracked down 37 surgical and dental patients who received possibly tainted tissue and verified each person had been tested. The state reported Thursday that none had tested positive for any illnesses.
John Stephen, commissioner of health and human services in New Hampshire, told the Associated Press it took his agency more than two weeks to get the information because the FDA was reluctant to provide a list of all health care providers who received the stolen tissue.
Officials at Pennsylvania and New Jersey health departments said Friday that, given the much larger health systems here compared to New Hampshire, both states expected hospitals to notify patients.
Five Philadelphia-area hospitals have acknowledged that patients received potentially contaminated tissue from Biomedical vendors.
Four patients from Albert Einstein Medical Center and one from Abington Hospital have been notified, along with eight from Jefferson and one apiece at Hahnemann and Temple. With an additional case from Holy Redeemer Hospital in Eastern Montgomery County, there are 16 known cases in the area.
At the shore, 15 patients at AtlantiCare Regional Medical Center in Atlantic City and Pomona and 63 patients at Shore Memorial Hospital in Somers Point received suspect tissue.