Visit the Web sites of some of the biggest and best known plastics companies and you may see a bold-faced announcement: "Our products are not for use in any human implantable applications."
That's been the case for more than 15 years, since an explosion of malpractice lawsuits involving breast and temporomandibular (TMJ) joint implants. For deep-pocketed chemical companies, the risk was too great and the potential reward too low for the relatively low-volume implant applications.
But times are changing, in part because of the very high prices that can be charged for implantable plastics and the growing market size. One observer, Larry Acquarulo, CEO of Foster Corp., says that the 1998 passage of the Biomaterials Access Assurance Act in an effort to protect implant material suppliers from civil liability has helped fuel interest from major chemical companies. Foster is a compounder of custom materials for implantable applications.…