Are silicone breast implants safe?

The FDA recently (November 2006) issued an approval that will allow the unrestricted use of silicone breast implants for most women. In the early 1990’s, silicone breast implants were removed from the market due to safety concerns. However, data that has been gathered since that time has proven these implants to be safe. This data was gathered over the last 14 years through an adjunct study that allowed the use of silicone implants for only very select patients. I am one of the surgeons who participated in this study, and I have been using silicone breast implants for over 20 years.

We offer silicone breasts implants in our office for women seeking breast enlargement, as long as they are over the age of 22. (The FDA feels that in some women breast development may not be complete until age 22.) Silicone implants can also be used in any women seeking breast reconstruction, or the correction of developmental abnormalities.

Plastic surgeons, who have not had experience with silicone implants through this study over the last 14 years, must complete a device education course prior to using these implants.  There are important differences in the use of saline and silicone implants. Understanding these differences comes with experience.

There has been so much talked and written about silicone implants for more than a decade. This has resulted in confusion on the part of many patients. This action by the FDA truly clears the air on the safety and use of silicone implants. And, most importantly, it has given women considering breast surgery important choices in the type of implant they wish to receive.

Silicone gel breast implants were first developed in 1961. Because of some concerns in the 1980s about a correlation of silicone gel with some medical problems, silicone implants were removed from the market in 1993. This was done, unfortunately, before significant studies were performed to prove or disprove any of the allocations against silicone.

These studies were subsequently performed, however, and in these major studies, no significant correlation has been found between silicone breast implants and the connective tissue disorders that were of concern years ago. For this reason, silicone gel breast implants were returned for public use with an endorsement by the Food and Drug Administration in 2006.

Silicone gel breast implants have the advantage of a smoother, more natural feel than their saline filled counterparts. Like the saline breast implants, the outer coating of the silicone breast implants are made of a silicone shell. These implants come pre-filled, and therefore must be placed into the appropriate pocket behind the breast through a slightly larger incision. Once in place, however, silicone implants are thought to show less rippling and have a more natural overall feel to them.

Silicone breast implants are often recommended for women who have very little breast tissue preoperatively, when they will be easily felt through the overlying skin and small amount of breast tissue.

Like any device in medicine or, in fact, life for that matter, breast implants can fail after a period of time. This may be in the form of a rupture of the outer shell of the implant, causing the saline or silicone to leak out. With saline breast implants, the saline is absorbed by your body without a problem, and your affected breast becomes “deflated” or smaller again. With silicone gel implants, however, your body does not absorb the leaking silicone in the same way, and therefore there may not be any outward signs of any problem.

Because of this, the FDA has recommended that patients who have silicone breast implants are checked with magnetic resonance imaging (MRI) periodically to make sure that there are no problems with their implants. In the case of rupture of either a saline or silicone breast implant, replacement is indicated and can be easily performed by your plastic surgeon.

Gel implants: the basics

In the time since the moratorium was lifted, gel implants have gone from being used in my practice on rare occasion to being used in about half of the breast augmentations I perform.  Patient satisfaction has been excellent and I have been very pleased with the performance of the new ‘cohesive’ gel material.

Gel implants are inserted pre-filled and thus require a larger skin incision than is used for saline implants.  For this reason the most commonly used incision is one placed in the inframammary fold.  The peri-areolar incision is acceptable in patients with a wide areolar diameter, but does not work as well if the areolar diameter is small.  An axillary (underarm) incision can be used but only for implant volumes up to 250 to 275cc. 

One distinct advantage of gel implants is the fact that in almost all cases the edges and anterior surface of the implant are not palpable, and it is thus very difficult to detect by touch or feel that an implant is present.  In many cases it is actually impossible to detect the implant at all. This makes gel implants a very attractive option for women who are quite slender and have a small natural breast volume, as saline implants are usually very easily detected by touch or feel in these patients. 

The gel implants that are currently available are filled with a gel material that is called ‘cohesive’, which essentially means that the gel is semi-solid instead of semi-liquid.  In the event of an implant rupture the cohesive gel material sticks together instead of having the ability to ‘run’ or ‘spread’ as did the older, semi-liquid gel material.  Because the cohesive gel material is semi-solid, cohesive gel implants feel somewhat firmer than the semi-liquid gel implants that are no longer in use, and they also feel firmer than saline implants (unless saline implants are overfilled to their volume limit).

The primary ‘downside’ of gel implants is the fact that an implant rupture can not be detected by appearance or feel.  The gel material is inert and is not absorbed by the body, so the size and the appearance of the augmented breast does not change if a gel implant’s outer shell ruptures.  Because the body forms a fibrous capsule made of collagen around all implanted medical devices, a gel implant rupture is usually contained by that fibrous capsule, and thus the gel material is not free to migrate to other sites in the body.  Escape of gel material outside the fibrous capsule following gel implant rupture appears to be fairly uncommon.

The only way to detect a gel implant rupture is by means of a radiological examination such as an MRI.  The FDA has recommended that women receiving the new cohesive silicone gel implants undergo postoperative MRI scans to monitor for implant rupture.  Postoperative MRI scanning is not a requirement – it is voluntary on the part of the patient.  The FDA’s recommended protocol is to have the first MRI three years postoperatively, then every two years thereafter.  Many plastic surgeons feel that this schedule of MRI scans is excessive and unnecessary, and have requested that the FDA modify their recommendation.  If an implant rupture is detected on a breast MRI scan the FDA also recommends that the ruptured implant should be removed and replaced.

According to the FDA, the newer generation silicone gel implants are safe for general use. No longer do patients have to fit into special catagories to have these products used rather than saline. There have been no medical devices studied more extensively by the FDA than gel implants.

Since silicone implants were pulled by the FDA for general use, they have undergone rigorous scientific studies evaluating their safety. The results of these studies suggest that the implants are indeed safe and find no statistically significant increase in symptoms of Human Adjuvant Syndrome as compared to a control population.

In several recent surveys of U.S. Board Certified Plastic Surgeons, the vast majority supported the return of silicone breast implants and felt them to be not only safe and effective but also a more natural alternative to the saline implants.