The Food and Drug Administration is expected to try to reduce vision complications caused by plastic lenses -- devices implanted in cataract patients' eyes -- in the wake of complaints from Ralph Nader's health group.
Some 100,000 patients a year are having the plastic intra-ocular (inside the eye) lenses surgically installed. When they work well, they restore vision remarkably, both eye doctors and patients report.
But Dr. Sidney Wolfe, Nader Health Research Group director, has twice told Health, Education and Welfare Secretary Patricia Roberts Harris that hundreds of people's vision has been impaired by overuse of the surgery, or poorly made lenses.
The matter of the lenses -- strongly defended by many eye doctors -- will evidently be the first major medical decision confronted by FDA Commissioner Jere Goyan, who took office Oct. 2.
Wolfe said in September the lenses were effective when properly used. But he maintained they still should be regarded as experimental.
Instead, he said, there is much "inappropriate and poorly controlled mass marketing," with ill effects ranging from eye loss or reduced vision to repeated surgery or infections.
Many eye surgeons called te Wolfe charges unfounded and said there are adverse reactions in only a fraction of the cases.
The FDA last week made available an interim report from its advisory committee, headed by Dr. David Worthen of the Veterans Administration Medical Center, San Diego. It said one of four varieties of lenses -- the anterior chamber lens -- has been associated with a number of complications.
But many serious complications occurred less often after implantation of plastic lenses than after traditional cataract surgery, the committee added.
Wolfe called the committee's data incomplete and misleading. He cited:
FDA documents showing that some FDA medical advisers have called the lenses unsafe. One spoke of seeing many eyes "almost blinded" by complications.
Data from California Blue Shield showing that in 1978 California eye doctors submitted Medicare claims for 179 cases in which reactions were severe enough to require a second eye operation.
A study saying lenses from some manufacturers fail to meet "minimal standards of optical quality" to ensure proper vision.
Wolfe urged FDA to "implement as soon as possible a sunshine policy" to give prospective patients the pros and cons on treatment alternatives, as well as lens quality data.
Wayne Pines, FDA associate commissioner for public affairs, said the agency intends at the least "to make available to physicians and patients as much information as we have so they can make choices."