How Often Do Silicone Breast Implants Need to Be Replaced?
There is a myth floating around the general community about this one. Often patients will present to their plastic surgeon stating, "It has been 10 years and I was told I need to have my breast implants replaced". This is not necessarily the case.
Breast implants are not like tires which should be rotated every few thousand miles. The only reasons that implants need to be replaced is if there is are problems related to the implant. These problems can range from rupture, capsular contracture or implant displacement. The rates of these complications varies depending on the type of implant. The good news is that in the event an implant does need to be replaced, implant manufacturers currently replace both saline and silicone breast implants at no charge and will sometimes cover surgeons fees as well.
Silicone breast implants have been around since the 1960's. There have been four generations of these implants. The "first generation" silicone implant was developed by Dow Corning. These were fairly thick shelled with fairly cohesive silicone. The desire for a more natural feeling implant was the impetus for the creation of the "second generation" in the 1970's. These had a thinner shell and more liquid silicone. These had a high rupture rate and high rate of silicone "bleed" through the thinner shell leading to complications such as capsular contracture.
The "third generation" was created in the mid 1980's with a thicker shell and again a more cohesive silicone gel contained within this shell. These are the silicone prostheses currently used in the United States for breast augmentation. They were approved by the FDA in November 2006 after the "FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. "The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices".
The "fourth generation" of implants is the "gummy bear" implants which are not yet approved by the FDA for use in the U.S, although used extensively in Europe. These have an even more cohesive silicone to provide a more form stable silicone and presumably less risk of rupture.
Determining the rupture rates of modern silicone implants is difficult because of the variety of types of implants currently in play. A few studies looking only at the currently used 3rd generation implants would suggest that the rupture rates are around 15% at 10 years. The information used by the FDA for approval of these implants showed a 0.5% rupture at 3 years. This is probably a little misleading as the risk of rupture increases with the age of the implant. Most studies using MRI data would suggest that most 2nd generation implants were ruptured by 10 years. Many of these were "silent ruptures" without symptoms. Only after there is enough experience with the newer generations of implants will their long term rupture rate be determined. Based on the cohesiveness of the implant, improved technology and durability of the shell, it is expected that these will have an improved rupture rate.
There is some controversy as to whether an implant which has ruptured "needs" to be removed. Many women have "silent ruptures" that cannot be detected by symptoms or physical exam. The FDA recommends MRI testing at 3 years after placement of silicone implants and every 2 years thereafter. In reality, this is an expensive proposition and few surgeons or patients follow this recommendation to the "T'.
In reality, there are many women with silicone implants whom do not know that they have a rupture. Certainly, if there is a diagnosed rupture either on physical exam, mammogram, or MRI - the FDA recommend that it should be removed as it is a failure of the device. There are a few studies that show increased symptoms such as fatigue, memory loss, fibromyalgia, and joint pain in patients with ruptured silicone implants as compared to controls. Many patients report that these symptoms resolve after removal of the implants. There are also reports of anti-silicone antibodies in the bloodstream in patients with ruptured implants and migration of silicone through the lymphatics. This is still an ongoing source of controversy.
Where there is controversy, better to be on the side of patient safety and most plastic surgeons recommend removal of diagnosed ruptured silicone implants.
Another relatively common reason for implant removal and replacement is capsular contracture. This is a hardening of the capsule, which is the envelope the body creates around the implant. Usually the capsule is soft and unnoticeable. When contracted it can be firm, distorted or even painful. Causes of capsular contracture are not entirely known but factors such as infection, silicone bleed, and hematoma seem to be involved. In Mentor's core study of 3rd generation implants the contracture rate at 3 years after augmentation was 8.1%. This is much more common at three years than rupture. There is less controversy regarding the "need" to have the implant removed in cases of capsular contracture. Generally, this is performed if it is severe enough that the patient would like to have the implant removed and replaced. Sometimes conservative therapy with Accolate (an oral medication) can be effective.
Again, the long term data regarding capsular contracture in these 3rd generation implants is lacking. The post-approval studies which are ongoing will help to clarify some of these risks.
In conclusion, the risk of failure becomes higher the longer an implant has been in place. According the the FDA and the package inserts from the implant manufacturers, implants are not meant to be a permanent device and most patients will need to have them replaced at least once. For saline implants, so long as they do not rupture or cause problems, they never need to be replaced. The same is true for silicone implants, however there is the risk of the "silent rupture".
The FDA recommends frequent MRI studies to diagnose the silent rupture. This is cost prohibitive for many patients. There may be an recommendation to have silicone implants replaced at a regular time interval when the results of the post approval study come out. For now, they should be replaced only if they fail.