A conversation with Dr. Mark Peters on
Saline Implants vs. Silicone Gel Filled Implants
When were silicone implants put back on the market and how do we know they are now safe? The FDA approved the silicone gel filled implants for general use in November 2006. In 1992 they were restricted in the market because they were suspected of contributing to systemic illnesses. The manufacturers of the implants cooperated fully with the FDA and always maintained the implant’s safety. Over 3000 peer reviewed studies have been conducted over the past 15 years showing silicone was and is unrelated to any medical problems in women. There are also over 33 epidemiologic studies showing no statistical differences for auto immune disorders occurring either with or without implants and after following over 30,000 women receiving silicone gel filled implants, there is no association with connective tissue diseases.,Silicone implants have been the most scrutinized device ever and as it turns out, were never “unsafe.” There is no reason to hesitate when choosing a silicone implant. In fact, throughout the study period while silicone was denied to primary augmentation patients, those patients requesting a revision or those needing reconstruction were allowed silicone implants with no adverse reactions reported.
What are the pros and cons of silicone vs. saline?
Both saline filled implants and silicone gel filled implants come in different profiles (moderate, moderate plus, and high), surfaces (textured and smooth), and shapes (round and “tear-drop”). Each implant has different advantages and disadvantages; each produces a different “look” for the patient. Although either implant is capable of producing a natural appearance, the silicone gel filled implant feels and looks more like natural breast tissue. Patients desiring a more defined “takeoff” (this is the transition between the chest and the top of the breast) seem to prefer the saline filled implant which results in a more defined upper pole. There is a cost issue. The silicone gel filled implant costs about $750-800 more than the saline filled implant. While neither are considered lifetime devices, both come with similar warranties.
In general, I spend time with each patient listening to the type of features they are seeking for their new breast shape. I stop short of recommending one implant over another because I feel that the choice of implant is such a personal one. I am willing to tell patients which will look the best given their anatomy, but ultimately it is their decision.
I’ve heard that saline gives the doctor more options. What does that mean?
Simply put, the saline implant has the ability to be adjusted in the operating room. In other words, the surgeon can fill the implant with a range of saline to optimize the symmetry. The silicone gel implant comes filled and therefore set in its volume. Although sterile sizers (these are “test” implants) can be used to optimize the symmetry, the gel implants come in fixed volume increments (300cc, 325cc…and so on) so some asymmetry of the breast volume may result. When the patient is having a breast augmentation without a lift, the incision required for the silicone gel filled implant is longer than the incision for the saline. This is due to the fact that the saline implant is empty, then filled; and the silicone gel implants comes filled. Therefore, if you choose to have silicone, you will probably not have the option of a transaxillary (under the armpit) incision.
You have said they are both safe, but does one have more complications than the other?
Implants have their own potential complications (see the Breast Augmentation Complication section) and there are difference between the silicone gel filled implants and the saline filled implants. Regarding the rupture and deflation of the implants, the silicone filled implants have a much lower rupture rate than the saline. This is, in part, due to the filling valve found on the saline implant. When saline implants deflate, the saline is absorbed by the body and the determination that it is deflated is relatively easy (there is a volume change over a 24-36 hour time period). Determining whether a silicone gel filled implant is ruptured is more difficult because of the cohesive gel which is now used to fill these implants. If you were to cut a gel filled implant in half, the gel would remain without “oozing” out. It would be as if you cut a gummy bear candy in half. Externally, you would likely not see any changes in the breast. This is referred to as “silent rupture.” Overall, less than 4% of patients ever experience a rupture of either type of implant during the first seven years. The risk of rupture continues to increase over the life of the implant.
The gold standard test to assess the integrity of the silicone gel filled implant is MRI. The MRI also has to use special equipment (breast coils) in order to evaluate the implants and not every MRI facility has them. The FDA actually recommends getting an MRI the third year after surgery and then every other year. This is not required and it is simply guidelines issued by the FDA when they approved the gel filled implants for general use. The cost is prohibitive, so while it is recommended we don’t know how many patients follow these guidelines.
Capsular contracture rates are generally regarded as being higher when using silicone gel filled implants. This is due to the fact that when the implants are passed through the incision, the silicone gel filled implants come into more contact with the skin. And as mentioned in the Complication section, the exposure to the skin bacteria is greater and, therefore, resulting in a higher capsular contracture rate for the silicone gel filled implants. My personal experience has shown less than 1% with either the silicone or saline implants due to the betadine and antibiotic solution protocol I use during surgery.
Can I have either implant under or over the muscle?
I will uniformly place the saline filled implants under the pectoralis major muscle. This is due to the fact that the saline implant is easily felt (rippling) and can be seen. When a patient selects a silicone gel filled implant, I have the option of placing the implant above the muscle. In this location, the implant has a more direct effect on the breast effectively producing a more natural shape. This would be true for the saline filled implant as well, but I believe that the benefit is outweighed by the rippling. The placement of the implant above the muscle shortens the recovery period and is less uncomfortable than placing the implant beneath the muscle. Any discomfort is easily managed with oral medication and should not be a consideration when selecting an implant since the recovery in either case is brief when compared with the life of the implant.
Where can I get more information?
If you wish to read more about breast implants, then you can go to https://www.breastimplantsafety.org.