SANTA BARBARA, CA: Burson-Marsteller and MS&L are representing the two companies that have received FDA approval to market silicone breast implants commercially for the first time in 14 years.
On November 17, the FDA gave Mentor Corp. and Allergan Inc. the go-ahead for their respective silicone gel-filled implant products, with post-approval conditions designed to further monitor the controversial decision. The marketing is also restricted to women aged 22 and older.
Representatives at both companies declined to discuss specific marketing plans for the implants because of the competitive environment.
MS&L has been working on the project for two years, according to Wendy Lund, MS&L EVP global business and client development. The agency began working with Inamed Corp. in the lead-up to the April 2005 FDA hearing on their product and continued to work on the effort following Allergan's acquisition of Inamed last March.
"It's really in so many ways a historic health event and definitely the biggest healthcare PR event of 2006," Lund said.
Burson has been representing Mentor for about two years as well, according to Ame Wadler, Burson chief strategist and chairman of global healthcare.
The FDA's decision came after a lengthy review in which both companies provided clinical and non-clinical data. In addition, a report from the Institute of Medicine found that there were no cases of connective tissue disease or cancer associated with the implants.
Previously silicone had been the target of litigation surrounding breast implants, which eventually cost Dow Corning Corp. $3.2 billion in a 1998 settlement reached with 300,000 women who said they were harmed by the company's implants. They had been taken off the market in 1992.
Both companies involved in this decision, however, voiced their approval of the FDA in separate statements, saying the agency let science, and not politics, prevail.