When Second World War Spitfire pilots found they could tolerate fragments of shattered plastic windshields deeply embedded in their eyes, medical scientists knew they were on to something. That discovery led to the first implantation, in 1949, of an artificial lens to replace the eye’s own— a surgical procedure that an estimated 10,000 Canadians undergo each year following the removal of a natural lens, usually due to cataracts. Though the tiny plastic lenses offer elderly and often arthritic patients freedom from tricky contact lenses or thick and powerful glasses, bad news sometimes has a way of following good. There is increasing evidence of more frequent side effects, including blindness, which is causing eye specialists and governments to question whether the risk for some outweighs the rewards for many.
So serious are the doubts that last month the Bureau of Medical Devices in Ottawa began random quality-control testing of imported lenses. And the U.S. Food and Drug Administration (FDA), which late last year restricted use of one of the four types of lenses available,
is stepping up inspections of manufacturing plants and their finished products. In June the FDA seized a batch of resterilized and unacceptable lenses, some of which were destined for sale in Canada.
A rash of lawsuits against American manufacturers also prompted the FDA to mount a two-year study of 177,000 people who have the implanted lenses. It recently concluded that only two per cent of the 177,000 suffered complications such as glaucoma or corneal damage and only 20 patients may have lost their vision due to the surgery. But the FDA findings don’t begin to reveal the
true hazards, says Chicago eye specialist Dr. Thomas Chalkley, because the onus was on surgeons to report problems resulting from their own surgery. Last month Chalkley, who doesn’t implant lenses, told an FDA public hearing that in his practice alone he is treating 25 patients with complications, 16 of whom have become legally blind in one eye or both.
Ralph Nader’s consumer advocate group has also stepped into the legal and medical fray, suing the FDA and several manufacturers to force public disclosure of adverse effects on a lensby-lens and company-by-company basis. It is unclear whether problems are due to poor selection of patients, bad lenses or bad surgery (surprisingly, the 900-member Canadian Ophthalmological Society blames the selection and surgery, maintaining that lenses are usually high-quality). But Nader’s people are focusing mostly on the lenses. “We want lenses coded to trace problems back to manufacturers,” says Robert Leflar, lawyer for the Washingtonbased Public Citizen Health Research Group. “And we want the removal immediately of unsafe or ineffective lenses. Without such protection, Canada may become the dumping ground for lenses which don’t make the grade here.” Diane Francis
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