For years, even the mention of silicone breast implants caused women everywhere to cringe. You may remember when the U.S. Food and Drug Administration (FDA) pulled silicone breast implants off the market because of their tendency to rupture. Now, the FDA approves the use of gel-filled silicone implants from five different manufacturers.
What are silicone gel breast implants?
Silicone gel breast implants are pre-filled, unlike the saline implants that are filled once they are placed under the patient’s muscle. Since they come pre-filled, they’re ordered in the requested size and cannot be changed. They consist of a silicone outer shell and are filled with a silicone gel. In most cases, plastic surgeons have to make longer incisions to place a silicone gel-filled breast implant than would be used for a saline-filled breast implant.
What were the concerns around silicone implants?
In addition to rupturing, there was also concern that silicone breast implants had links to cancer. In the past decade, many independent studies were performed to examine whether there really was such an association to cancer or to connective tissue disease. These studies concluded that there is no convincing evidence that silicone breast implants are associated with either of these.
How were silicone implants approved for general use?
Additional studies were in place to give the FDA the data they required 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 to have silicone implants.)
After rigorous scientific review, the 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 approved products were made by Allergan Corp. (formerly Inamed Corp.) and Mentor Corporation. Mentor Corp.'s silicone gel implants are called the MemoryGel Breast implants.
At present, the following companies produce FDA-approved silicone gel filled implants:
- Allergan Natrelle (Premarket application number: P020056) (Approved November 2006)
- Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Premarket application number: P040046) (Approved February 2013)
- Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006)
- Mentor MemoryShape (Premarket application number: P060028) (Approved June 2013)
- Sientra’s Silicone Gel Breast Implants (Premarket application number: P070004) (Approved March 2012)
What is the future of silicone implants?
Now that the products are 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.
Updated July 2016