WASHINGTON — Since President Clinton signed legislation last summer to give liability protection to resin manufacturers selling into the medical implant market, there hasn't exactly been a stampede of entrants.
But there has been some movement, and some observers take that to mean the Biomaterials Access Assurance Act is starting to work.
Giants like Dow Chemical Co. and DuPont remain on the sidelines, either abandoning the market because it is too small for the risks involved, or waiting for a court case to test the new law.
The law was meant to stop resin suppliers from leaving the implant market because they could be drawn into lawsuits over defective implants, even if the resin itself was not at fault.
Some observers say smaller companies will be the first back in, because the medical industry may be a more important market to them, or because they do not have the deep pockets that make them an attractive target for lawsuits.
Thermedics Inc. in Woburn, Mass., remained in the implant market.
Victrex USA Inc. is entering the business because the legislation gives it additional liability protection.
``It's my sense that things aren't really sorted out yet,'' said Carl McMillan, a biomaterials consultant in Brecksville, Ohio, and former scientist for spine-implant maker AcroMed Corp. ``The majority of the companies have not decided what they are going to do. A lot of them are looking around and waiting for a test case to go through.''
Dow thinks the legislation does not give enough protection, said Nancy Hermanson, medical market technical leader for Dow Plastics in Midland, Mich.
``Until the uncertainties of the bill are worked out, we will continue to restrict our products in medical,'' she said. ``The rules are still uncertain and the potential risk is still high.''
The bill provides liability exemption to general materials that can be used in medical applications, but not to materials developed specifically for the medical market, Hermanson said. Also, the bill does not provide enough protection for short-term implants, according to Hermanson.
Dow stopped supplying materials for pacemaker leads, and decided to stick with limiting most resins to devices left in the body for less than three days, or 30 days for its polyurethane, she said. The company will be watching how the new law fares in court.
DuPont, which was dragged into years of expensive litigation after very small amounts of its Teflon fluoropolymer were used in poorly made jaw implants, said it has no interest in the implant market.
``It is not practical for us to make [DuPont resins] available for those niche markets,'' said DuPont spokeswoman Nancy Tidona. ``As they were drafting that legislation, we made it very clear we would not get back into that market.''
Victrex USA Inc. is making its polyetheretherketone resin available for hip, spinal and dental implants for the first time, said Kevin Jennings, marketing manager with the West Chester, Pa., company. The resin can be tailored to match the stiffness of human bone, he said.
``The fact that the law was passed and came into being was a big contributing factor in us taking a look at our strategy,'' Jennings said. ``We think it's a potentially attractive market.''
The law also gives companies that did not leave the implant market more flexibility, said Daniel Brown, Thermedics vice president.
``We're willing to look at more variations on supplying the material,'' Brown said, adding that the company might work with smaller device manufacturers even though they might provide less indemnification.
Thermedics kept its polyurethanes in the market because it was able to get enough indemnification, according to Brown.
However, implant research and development efforts could suffer if large companies fail to return to the market, said James Benson, executive vice president of technology and regulatory affairs for the Health Industry Manufacturers Association based in Washington.