Top > Business > 2006 > November > 2006-11-23

Allergan Received US Approval Its Silicone Breast Implants

The Food and Drug Administration ended its restrictions Allergan`s Silicone Breast Implants. The breast implants are designed for reconstructive surgery after mastectomies or deformities as well as cosmetic surgery that is becoming increasingly popular. Approximately 290,000 women received cosmetic implants during 2005, representing a 37 percent increase in a five-year period. The increase is due to proliferation of cosmetic surgery into popular culture with ``reality`` programs featuring the procedure on television, encouraging many young women to seek implants.

Breast implants still come with risk of adverse complications. Among the risks named by the FDA are: hardening of the breast tissue, pain, shape and position change, lost sensation, infection, calcium deposits, muscle pain, fatigue and the likelihood of follow-up surgeries. The FDA hadn`t found evidence that implants could cause connective-tissue diseases although Dow Corning had agreed to pay $3.2 billion to 300,000 women, who claimed to have connective-tissue and auto-immune diseases linked to silicone implants.

Allergan and Mentor, who have already received FDA approval for their silicone breast implant, will sell silicone implants for about $600 each in the US. It is estimated that the U.S. market for saline and silicone implants will grow from $215 million in 2005 to $542 million in 2009. The FDA decision will likely doubles Mentor`s core earnings power, while Allergan that has a more diversified product list will be less affected. Mentor manufactures plastic surgery devices, while Allergan sells Botox, eye care products and skin treatments.