Breast Implant Manufacturer to Return to U.S. Market

Originally Published MDDI November 2003

NEWSTRENDS

Erik Swain

The world's third-largest breast implant manufacturer is finally ready to reenter the U.S. market. It has been absent since 2000, after FDA barred the marketing of breast implants that had not gone through clinical trials. Eventually it may bring the first titanium-coated breast implants to the United States. 

Poly Implants Prostheses Inc. (PIP; La Seyne-Sur-Mer, France) announced at a press conference on September 10, 2003, in New York City that it expects to receive marketing clearance for its saline prefilled breast implants by the end of 2003. 

Until 1999, breast implants only required 510(k) clearance. But that year, FDA ruled that as of May 2000, PMA clearance would be required. PIP did not have the necessary clinical data and withdrew from the market until now. Jean Claude Mas, PIP's chairman and chief executive officer, attributed the delay in part to “difficulties in following up with patients.”

That was a setback for the company, as the United States represents 55% of the $1.2 billion breast implant market. While the firm remained profitable, revenues fell from $14.1 million in 1999 to $5.9 million in 2002, and its auditor raised questions about its viability. But in March 2003, Heritage Worldwide Inc. (New York City) acquired PIP, easing financial concerns. 

In recent years, PIP has helped develop titanium-coated breast implants, which it says makes the implants more biocompatible. PIP received a CE mark for that product on September 9, 2003, and hopes to receive FDA clearance in three to four years. 

Other company goals include obtaining 25% of the U.S. saline prefilled breast implant market by 2006.

The major question is whether PIP can recapture market share from its larger competitors, Mentor Corp. and Inamed Corp. (both Santa Barbara, CA). A report by The Research Works Inc. (Sea Girt, NJ) noted that they have “significantly greater revenues, market share, name recognition, and financial resources” than PIP. But Mas is confident PIP's products will find acceptance, citing many surgeons “who are waiting for me to come back.”

The breast-implant market may be further altered if FDA lifts its ban on silicone-gel implants. Inamed told the agency it has evidence to show that silicone implants do not require follow-up surgery any more than their saline counterparts do. In mid-October, Inamed argued its position before FDA's General and Plastic Surgery Advisory Panel. The panel voted on October 16 to recommend Inamed's silicone implants as “approvable with conditions.” 

Copyright ©2003 Medical Device & Diagnostic Industry