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Issue Date: March 2007


Ask the Plastic Surgeon

Question:  I heard that the FDA has allowed silicon gel implants back on the market. Does that mean that anyone can get them now? 
Question:  I heard that the FDA has allowed silicon gel implants back on the market. Does that mean that anyone can get them now? 

Answer: It is true that the FDA has recently approved the use of silicone gel implants for primary breast enlargement.  Previously they could be used in restricted conditions; the patient had to be meet specific criteria, and the physician doing the surgery had to be part of an ongoing national clinical study.  Now that all the data from this study has been reviewed and the implants were deemed safe, they have been made available to the public in general. 

Both companies that manufacture and distribute silicone gel implants still have an ongoing clinical evaluation taking place which you may or may not choose to participate in. Presently, the only conditions set for women choosing to have breast enhancement with silicone gel implants are, the patient must be at least 22 years of age (an arbitrary age set by the FDA), cannot be pregnant or nursing at the time of surgery, cannot be treated for infectious diseases at the time of surgery, and cannot have an existing breast cancer that is untreated at the time of surgery. This follows the common sense pre-surgical screening that most qualified surgeons would follow with the exception of the subjective age qualification.

   Your surgeon should discuss with you the differences between the silicone and saline implants as they apply to the various placement options available. Your evaluation of which type of implant to use would also be based on your physical stature, the type of look that you want, and your life style.  These are all factors that your surgeon should be willing to review with you, as well as the risks and complications associated with each type of implant and procedure.
 
Submit your questions to “Ask the Plastic Surgeon” at allnewu@AOL.com. Questions may be condensed and reformatted for the column.
 
Questions are answered by Dr. Mark A. Foglietti, a nationally recognized board-certified plastic surgeon and author.

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