Silicone Gel Breast Implants are FDA approved

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For years even the mention of silicone breast implants caused women everywhere to cringe. Many women may still remember when the FDA pulled silicone breast implants off the market because of their tendency to rupture. Now, after more than a decade, the FDA has APPROVED the use of gel filled silicone implants.
The FDA’s reasons for studying the new high strength gel silicone breast implants was purely for reasons of safety. Plastic surgeons like silicone gel implants, not only because they are safe, but because silicone breast enhancements feel and look completely natural. Dr. Pousti has been involved with two studies for Mentor Silicone Implants and Inamed Silicone Implants for the past 10 years and therefore has experience with using these silicone gel implants on many patients. These studies were in place to give the FDA the additional data they require before they would approve silicone breast implants for general use. Women who qualified for participation in these studies had to meet the following criteria:

  • You are a mastectomy patient and are undergoing reconstructive surgery.
  • You are having revisionary surgery and already have saline implants.
  • You are having a breast lift (mastopexy), in addition to breast augmentation.
  • You have a chest wall deformity (pectus excavatum, pectus carinatum, possibly scoliosis).

At this time, you do not need to meet the above criteria.

After rigorous scientific review, the U.S. Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The products are made by Allergan Corp. (Formerly Inamed Corp.) and Mentor Corporation. Mentor Corp.’s silicone gel implants are called the MemoryGel Breast implants.
In the past decade, many independent studies have been performed to examine whether silicone gel-filled breast implants are associated with connective tissue disease or any cancers. These studies have concluded that there is no convincing evidence that breast implants are associated with either of these diseases.
Now that the products have been determined to be safe, the FDA will continue to monitor them by requiring each company to follow about 40,000 women for 10 years after receiving the breast implants. This is normal practice for the FDA so that they will be able to answer important questions that could only be answered once the product is in broader use. The post-approval studies will be closely monitored by the FDA.
If you would like to discuss your options regarding using silicone gel-filled breast implants, it is required that you schedule a consultation with a board certified plastic surgeon who has been approved to perform silicone breast enhancements with these implants. Dr. Pousti is one such plastic surgeon.
Silicone gel breast implants are pre-filled, unlike the saline implants that are filled once they are placed under the muscle of the patient. Surgeons order them in the requested size and they cannot be changed. Plastic surgeons have to make longer incisions in most cases to place a silicone gel filled breast implant than a saline filled breast implant, all other things being equal.

Silicone Breast Enhancement Procedures

The surgical technique used for silicone gel implants will be discussed with you when you meet with Dr. Pousti. Silicone breast enhancement procedures take approximately two hours. Silicone gel implants are pre-filled and so the incision may be a little longer than those of saline filled implants. The pocket is made for the implant just as for the sali