Silicone implants never fully disappeared from the market, but for several years their use was limited and based only on specific medical criteria. Further, during those years any patient who received silicone implants was required to participate in a long-term study of health and safety.



The "silicone implant scare" seems to have been triggered by a combination of legal opportunism and some arguable medical "science", coupled with patient concerns over complications. After much debate, and based on extensive medical data, in November of 2006 silicone implants were once again approved by the FDA for use in breast enlargement surgery. A 13-member committee of the IOM (Institute of Medicine of the National Academy of Science) appointed by the U.S. Department of Health and Human Services determined the following at the end of their research:

"Evidence suggests diseases or conditions such as connective tissue diseases, cancer, neurological diseases or other systemic complaints or conditions are no more common in women with breast implants than in women without implants."

The FDA conclusion legitimized what most plastic surgeons already believed -- that silicone has always been a safe choice, and the decision about whether to use them should be left to the patient and his/her physician.

One of the restrictions included in the recent FDA approval is that the patient must be at least 22 years of age. Further, not all types of silicone were approved for general use. For instance, the newer, more cohesive implants - commonly known as "gummy bear" implants - require that the patient participate in a follow-up study. This doesn't mean the product is "unsafe" - it just means that the "gummy bear" implant wasn't one of the newer silicone products that made it into the November 2006 FDA approval. Manufacturers are currently working with the FDA to get these implants added to the list of approved gels.

There are significant improvements in the current gel implants. In the 1970's and 1980's silicone implants had a more liquid consistency, and the outside shells were thinner and more apt to leak. Today the implants have outer shells that consist of several layers and are made with an interior "cohesive" gel - one that is more stable and stronger. With the development of the newer gels there are also more implant "profile" choices for patients, helping to give them the look they want. The choice of multiple shapes and sizes are available in both saline and silicone implants.

Even though silicone implants once again have FDA approval, saline implants are still a good choice for many women. Saline is available for breast augmentation to women 18 years and older, unlike silicone where the minimum age is 22 years. Saline implants, like their gel counterparts, have silicone shells, but the inside is filled with salt water instead of the gel.

So what are the advantages and disadvantages of each? One of the advantages of silicone implants is that they feel more natural to the touch and there tends to be less "rippling" around the edges of the implant. For women who are thin or have small breasts or stretched skin, this is a distinct advantage. One disadvantage of silicone, however, is that the implants come pre-filled and a slightly longer incision is needed at surgery.

An advantage of saline implants is that they can be filled after insertion, making them ideal for those who prefer a transaxillary or transumbilical breast augmentation. (In the former, an incision is made in the armpit; in the latter, an incision is made in the navel and tunnels up to the breast. Both eliminate the possibility of any breast scarring.) Also, if a saline implant should leak it becomes readily apparent as the body quickly absorbs the saline. Saline implants also cost less than their silicone counterparts, and this is frequently a consideration.

When making the choice between silicone or saline implants, be assured that usually comparable and excellent results can be obtained with either type of implant. If you are over 22 years of age, the decision is entirely up to you. In the opinion of most plastic surgeons, either choice is a good one. The way to determine your own best choice is to meet with a board certified plastic surgeon to discuss the advantages and disadvantages of each.

Note: The specific risks and the suitability of breast enlargement surgery for a given individual can be determined only at the time of consultation with a surgeon. All procedures have some degree of risk. The information provided here is not a substitute for a consultation.