The increased acceptance and diverse applications of medical polymers for either temporary or permanent implants has persuaded many suppliers to return to the market following a mass exodus during the 1990s.
A number of high profile litigations during the decade (particularly breast and temporomandibular joint implants), saw many suppliers restrict offerings. However, the passing of the Biomaterials Access Assurance Act in 1998 helps to protect suppliers from civil liberty, with polyetheretherketone (PEEK), ethylene vinyl acetate (EVA), polyethylene (PE) and bio-resorbable polymers now considered the preferred materials for implantable devices.
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Foster Chief Executive Officer, Larry Acquarulo stated:
“The use of polymers in temporary and permanent implant devices is rapidly growing. Material suppliers who strategically positioned themselves for this market ten years ago have benefitted and paved the way for new suppliers and materials today.
“FDA 510(K) clearances of PEEK related devices are an excellent example. Companies introducing a new medical device for human use in the US market must first receive clearance from the FDA; the most common process is referred to as a 510(K).
“In 2001 there was only one FAD 510(K) clearance with PEEK polymer featured in the registered name of an implantable device. In 2011 there were 17 such clearances, and this year there were six in the first quarter alone.”
“Another example is the explosion of medical implant applications using bio-resorbable polymers (able to be broken down by the body). According to the US Patent and Trademark Office database, the number of patents issues referencing bio-resorbable and medical grew from 48 in 2005 to 311 in 2011, a rise of 548 percent. In 2012 there have been 229 related patents issues year to date.”