The U.S. Food and Drug Administration (FDA) has lifted its 11-year ban on silicone implants. But the decision is not without controversy.
The U.S. Food and Drug Administration banned most silicone implants in 1992 because of reports that ruptured implants and leaking silicone could lead to cancer, autoimmune disease and connective tissue disorders.
The FDA now says the claims are not supported by scientific review.
Spokeswoman Donna-Bea Tillman. "Based on extensive data on the implants, and because we've determined they are safe and effective."
Breast enlargement is one of the most popular cosmetic surgeries in many countries. One manufacturer (Mentor) says more than one million women in over 50 countries have had its product implanted.
The American Society of Plastic Surgeons applauds the FDA decision. Spokeswoman Dr. Roxanne Guy says, "We have listened to exhaustive studies. We have read reams of paperwork, and it's time for science to take back over here, where emotion has run rampant in the past."
Women, such as Denise Pardue, who simply wanted to enlarge their breasts, had been limited to saline implants. She plans to have her saline implants replaced by silicone. "I've gotten an opportunity to look at them and feel them and they just look and feel so much more natural to me."
Critics of the decision, like Diana Zuckerman, describe it as a "low point" for the FDA. "It really tarnishes their image to approve a product that has not been proven safe for long-term use."
The Food and Drug Administration is requiring implant manufacturers to conduct extensive safety studies --- following 40,000 women for ten years.
It is also urging women who get the implants to get regular checkups to make sure the devices have not ruptured.