His first transplanted cornea at one time tested positive for hepatitis B. He decides to play it safe.
Manuel Merrill learned last week that the gift of sight he had received a few weeks earlier might have the potential to kill him.
Merrill, a 72-year-old retired machinist, was informed by Tampa surgeon Dr. Stephen Maskin last Wednesday that his transplanted cornea had tested positive for hepatitis B, a potentially fatal disease.
Merrill agreed to the transplant after the cornea in his left eye deteriorated after several operations to fix a detached retina. After hearing that the new cornea might be contaminated, Merrill quickly made the decision to have the questionable implant removed.
The first implant was replaced in a one-hour operation Friday, and no traces of infection are apparent. But Merrill still wonders about the need for for the second operation.
"My feeling is if it checked positive once, I don't want it," said Merrill of Zephyrhills. "If it's life-threatening, it should be thrown out."
A cornea is the clear tissue covering the front of the eyeball that helps the eye focus. Most corneal transplants _ nearly 46,000 were done in 1999 _ go off without a hitch. Transmission of disease is rare because so little blood circulates in corneal tissue and because the U.S. Food and Drug Administration regulates corneal transplants rigorously.
In Merrill's case, neither Maskin nor the Central Florida Lions Eye and Tissue Bank, the non-profit agency that procured the corneas, had any idea the eye tissue exhibited signs of hepatitis B.
What had occurred is that the initial blood tests from the cornea donor, conducted by Bryce Clinical Laboratories in Tampa, proved positive for hepatitis B. But two subsequent tests showed negative results.
And according to FDA guidelines, the final pair of tests allowed Bryce to certify the donor's corneas as free from infection. The corneas were then placed by the Central Florida Lions eye bank with Maskin for transplant, with one cornea going to Merrill and the other to a woman.
What triggered concern over the possibility of contaminated tissue was an FDA inspection at Bryce revealing that protocol governing the blood tests had been incomplete, according to Jason Woody, executive director at the Central Florida Lions eye bank.
"One of the steps in the testing was missed," said Woody.
The testing lab notified the eye bank, which in turn notified Maskin.
Maskin was aware that Canadian researchers had documented two cases of hepatitis B being transmitted through corneal tissue. While he considered the possibility of infection in Merrill's new cornea as remote, Maskin nonetheless wanted his patient to have all the facts about his transplant.
"I think the most important thing is to allay a patient's concerns even if the odds of something happening are one in a million," Maskin said.
Faced with the same array of test results, Maskin pointed out, the female patient receiving the matched cornea chose to leave it intact.
The FDA declined Monday to elaborate on what federal inspectors had turned up at Bryce.
"I'm not going to comment about an investigation being conducted by the FDA," said agency spokesman Edward Atkins.
Damon Hyde, president of Bryce Clinical Labs, insisted that FDA procedures had been followed and emphasized that the FDA had ordered no tissue recall. Hyde explained that "a large number of false positives" crop up in his lab's serological tests.
"It's not uncommon," he said. "The issue here is we've got a patient who doesn't quite understand how the testing works."
Maskin and hospital support personnel decided to accept the Medicare minimum for Merrill's second operation. The $3,000 cost will be picked up by Bryce, and the second cornea was donated by the Central Florida Lions eye bank, according to Woody.
Maskin said the decision to have the second surgery may have been driven as much by his patient's psychological needs as by medical necessity.
"It probably wasn't necessary to remove (the first cornea), but these are people's emotions we're dealing with," Maskin said. "And I believe they had lost confidence in the testing lab."
Would Merrill's experience scare off other potential patients? Maskin hopes not.
"The miracle of successful corneal transplant changes people's lives," he said. "I'd be concerned if people see something here to discourage them from going forward."