UB Scientist Warns that Bad Publicity, Litigation May Produce Shortage of Implant Devices

BUFFALO, N.Y. -- Bad publicity and costly litigation involving some implants threatens to create a growing shortage of devices ranging from heart valves to joint replacements, an internationally known authority on implants at the University at Buffalo warns.

Robert E. Baier, executive director of the Industry/University Cooperative Research Center for Biosurfaces and professor of oral diagnostic sciences in the UB School of Dental Medicine, recently told colleagues attending the Sixth World Biomaterials Congress meeting in Hawaii that companies in the implant industry -- from designers and manufacturers to producers of materials used in the devices -- are getting "gun shy" and withdrawing their commodities from the market.

Even companies whose materials have been proven "safe" after years of use and laboratory analysis are less willing to market the products, noted Baier, who also holds positions at UB as professor of biophysics and mechanical engineering.

Companies are also becoming even less inclined to actively explore or develop new materials and products for human implants, he pointed out.

Although it's long been required that new drugs meet stringent guidelines required by the U.S. Food and Drug Administration in order to be admitted to the marketplace, the same rules do not govern implants, Baier emphasizes.

"It was only in 1976 that Congress passed legislation giving the FDA the authority to regulate these products," he said.

Even so, the law allowed existing products to be 'grandfathered' in and new ones still are not subjected to the strict and lengthy process that took years for a promising medication to make the journey from laboratory to market.

But, Baier said, there's a light on the horizon for the future of implants.

"Physicians, scientists, industry representatives and government agencies, including the FDA and the National Institutes of Health, now are working together to establish databases and systems to test and evaluate implants and biomedical materials before implantation," the UB researcher said.

He predicts that this aggressive, concerted, systematic approach ultimately will lead to products that are safer and more effective.

"Knowing that there are standardized, scientific guidelines governing admission of implants to the market will be reassuring to physicians who find them a treatment of choice for their patients," Baier continued.

Moreover, establishment of these guidelines, based on solid data collection and analysis, will encourage companies to explore new materials and devices to expand their variety and availability.

Baier noted that the implantation field developed and grew quickly following World War II.

For example, physicians observed that pilots hit with flying shards of polymethylmethacrylate -- a common plastic with many trade names, including Plexiglas, Lucite and Perspex, that was used in airplane windows -- did not appear to suffer immune system problems or have their bodies reject the material.

Later, other artificial materials gradually were introduced to replace damaged or diseased body parts.

"Now it's estimated that one in 25 people have a implant, the majority of whom have benefited from an increased length and quality of life," he said.

But strict guidelines, backed by improved scientific evidence governing the appropriate use of materials and design of implants, is a medical 'must' to ensure the safety of existing devices and encourage development of new ones," he emphasized.