NEW YORK: The U.S. Food and Drug Administration, in lifting a 14-year ban on silicone gel-based breast implants recently, has given a new option to women who are keen to maintain their shape, feel cosmetic surgeons in the country.
Several surgeons have reported there are inquiries with them about the new procedure and details about how soon such a procedure can be taken up. Some of the surgeons also said women, who were due to get saline-based implants, have postponed their procedures in the hope of going in for more effective silicone.
The FDA had taken years to study the possible side effects of using silicone for the implants before it announced the decision. Director of FDA's Center for Devices and Radiological Health Daniel Schultz said the agency had collated extensive evidence to reassure itself that there are benefits.
According to data, there were some 300,000 breast augmentation surgeries in the country in 2005, making the procedure the third most common cosmetic surgery. The other two popular procedures are liposuction and rhinoplasty.
With the new FDA approval, there will be two procedures available to women -- saline-filled implants for women 18 years and older and the silicone gel-filled implants for women 22 years and older. Two companies -- Allergen Inc. and Mentor Group -- make both the implants.
According to the FDA, silicone gel-filled implants would require frequent MRI scanning in order to ensure there are no ruptures. Saline implants do not have this risk. This is one reason why the FDA has prescribed age limits.
Allergen has said it plans to sell silicone implants for about $900 a piece, compared with $450 for saline. Mentor, will be selling its silicone products for $800 to $950 a piece, while its saline products are $550 to $625.
The total cost of a breast augmentation process could in the range of $6,000 to $10,000 using saline implants. Surgeons said on an average a silicone implant surgery could cost $6,800.
The FDA has brought an FAQ on breast implants listing general risk factors, choice of implants, and the site to report on problems with implants as medical evidence upon which it decided to lift the ban on silicone.
In the U.S., medical insurance does not cover cosmetic breast augmentation processes. Even the cost of post-operative investigations and repeat surgery, if required, may not be covered by the insurance. This cost can sometimes exceed the cost of the original surgery.
The FDA had banned the silicone devices in 1992 on fears that they could rupture and endanger women, possibly causing autoimmune diseases. In spite of the ban, the devices were available to cancer survivors as well as women who volunteered to be part of studies on safety of the procedure.
