er those diagnostic scans would be covered by medical insurance.

Dr. Scott L. Spear, chief of plastic surgery at Georgetown University, who conducted research for Irvine California-based Allergan,, said the devices are greatly improved since the early 1990’s.

“The shells themselves are made of different materials, a barrier shell, that i

The Food and drug Administration has decided to reverse the 1992 ruling and lift the 14-year ban on the use of silicone breast implants in the United states. Two California-based companies, Mentor and Allergan, have been approved to manufacture and sell what experts say is a newly designed and safer silicone implant.

Dr. Daniel G. Schultz, director of the F.D.A.’s Center for Devices and Radiological Health, said that the F.D.A.’s review of company-sponsored studies on silicone implants, as well as long-term use of the implants around the world, was enough to approve the use of the implants in the best interest of American women. Dr. Schultz cautioned however, that no device is completely foolproof and some implants may need to be replaced eventually due to leaks or ruptures.

“Women should know that breast implants are not lifetime devices,” he told reporters over the phone last night. “Women having these procedures done need to be prepared for the fact that there is a likelihood they will require additional surgery,” he added.

He also recommended regular M.R.I. scans to monitor for signs of silent rupture, which can occur without the woman’s knowledge and lead to silicone in the bloodstream among other complications. Schultz suggested the first test be conducted after three years of use. Due to the cosmetic nature of most implant procedures, it is not yet clear whether those diagnostic scans would be covered by medical insurance.

Dr. Scott L. Spear, chief of plastic surgery at Georgetown University, who conducted research for Irvine California-based Allergan,, said the devices are greatly improved since the early 1990’s.

“The shells themselves are made of different materials, a barrier shell, that is

ector of the F.D.A.’s Center for Devices and Radiological Health, said that the F.D.A.’s review of company-sponsored studies on silicone implants, as well as long-term use of the implants around the world, was enough to approve the use of the implants in the best interest of American women. Dr. Schultz cautioned however, that no device is completely foolproof and some implants may need to be replaced eventually due to leaks or ruptures.

“Women should know that breast implants are not lifetime devices,” he told reporters over the phone last night. “Women having these procedures done need to be prepared for the fact that there is a likelihood they will require additional surgery,” he added.

He also recommended regular M.R.I. scans to monitor for signs of silent rupture, which can occur without the woman’s knowledge and lead to silicone in the bloodstream among other complications. Schultz suggested the first test be conducted after three years of use. Due to the cosmetic nature of most implant procedures, it is not yet clear whether those diagnostic scans would be covered by medical insurance.

Dr. Scott L. Spear, chief of plastic surgery at Georgetown University, who conducted research for Irvine California-based Allergan,, said the devices are greatly improved since the early 1990’s.

“The shells themselves are made of different materials, a barrier shell, that i

foolproof and some implants may need to be replaced eventually due to leaks or ruptures.

“Women should know that breast implants are not lifetime devices,” he told reporters over the phone last night. “Women having these procedures done need to be prepared for the fact that there is a likelihood they will require additional surgery,” he added.

He also recommended regular M.R.I. scans to monitor for signs of silent rupture, which can occur without the woman’s knowledge and lead to silicone in the bloodstream among other complications. Schultz suggested the first test be conducted after three years of use. Due to the cosmetic nature of most implant procedures, it is not yet clear whether those diagnostic scans would be covered by medical insurance.

Dr. Scott L. Spear, chief of plastic surgery at Georgetown University, who conducted research for Irvine California-based Allergan,, said the devices are greatly improved since the early 1990’s.

“The shells themselves are made of different materials, a barrier shell, that i

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He also recommended regular M.R.I. scans to monitor for signs of silent rupture, which can occur without the woman’s knowledge and lead to silicone in the bloodstream among other complications. Schultz suggested the first test be conducted after three years of use. Due to the cosmetic nature of most implant procedures, it is not yet clear whether those diagnostic scans would be covered by medical insurance.

Dr. Scott L. Spear, chief of plastic surgery at Georgetown University, who conducted research for Irvine California-based Allergan,, said the devices are greatly improved since the early 1990’s.

“The shells themselves are made of different materials, a barrier shell, that i

er those diagnostic scans would be covered by medical insurance.

Dr. Scott L. Spear, chief of plastic surgery at Georgetown University, who conducted research for Irvine California-based Allergan,, said the devices are greatly improved since the early 1990’s.

“The shells themselves are made of different materials, a barrier shell, that is relatively much more impermeable,” he described. “The shells are thicker than in ‘91, much thicker than they were in earlier generations. The material inside is more cohesive, the stuff tends to stick together.”

Some health experts remain unconvinced, and criticized the agency’s decision to lift the ban.

Dr. Sidney Wolfe, chief of Public Citizen’s Health Research Group, which led the charge to ban the silicone enhancers in the 80’s due to concerns over cancer and other diseases, called the implants “the most defective medical device ever approved by the F.D.A.

Amy Allina, program director at the National Women’s Health Network, also sharply disapproved of the decision, stating the agency gave the implants the green light despite the manufacturers’ inability to answer basic safety questions, such as exactly how long implants would last without rupturing, and whether there would be adverse health effects if the silicone leaked and traveled to other areas of the body.

“We have been looking at this data continuously for the last 10 years. We have been watching as data had been collected, we have been watching as data has accumulated,” said Schultz. “We believe that from a scientific standpoint, the decision that we’re making tonight is, in fact, in the best interest of American women.”

He added the agency would require the companies to conduct ongoing post-s