Keeping Breast Implants Safe: Update on Silicone Gel Implants
by Kouros Azar, M.D.
Breast augmentation has gained tremendous popularity with more than 329,000 operations performed in the United
States alone in 2006. This represents a 55 percent increase in the number of procedures performed from 2000 to
2006 and the first time the procedure has been ranked most popular since the controversies raised in 1992.
Looking back, in early 1992 amid rising concerns and near-frenzied controversy, and legal actions against
manufacturers, the U.S. Food and Drug Administration issued a voluntary moratorium on the use of silicone
gel-filled implants for cosmetic breast augmentation. Despite nearly 30 years of clinical experience proving
implant safety, the FDA’s decision to delay the use of silicone implants was both wise and safe. The
manufacturers at the time did not have adequate data to fully address some of the complex issues that were
raised. Many patients had honest concerns that their silicone implants had caused major health problems such as
lupus or rheumatoid arthritis. For the next 14 years breast augmentation proved to be a widely desired procedure
and the saline filled implants filled the void. Meanwhile, the FDA and several other independent organizations
conducted experiments to prove that silicone gel implants did not cause systemic issues. After more than a
decade of research and conversation, including a 1999 report by the Institute of Medicine and the 2005 FDA
advisory panel hearing, during which the panel heard more than 20 hours of data and presentations as well as
public comment, the FDA made a decision.
On November 17, 2006, the FDA approved Allergan and Mentor’s silicone breast implants and placed them back
on the US market. The FDA decision along with research and reports from the last decade showed “that silicone
gel-filled implants do not pose additional risk to women’s short term or long term health.” Since the approval o
f silicone breast implants in November of 2006, their popularity has gained an all time high and many surgeons
are performing the overwhelming majority of their breast augmentations with silicone gel filled implants. In the
next ten years, we will continue to study the effects of silicone implants on our patients and will ultimately
have nearly 4000 patients enrolled in these post-approval studies.
There are many ways in which our patients are being informed regarding the new approach to using silicone
gel implants. Most surgeons are spending more time informing patients about silicone implants. The implants have
been re-designed and currently used implants are third generation with lower risk than ever, Current and future
generations of implants have a lower risk of gel bleeding out of the implant shell due to improvements in the
viscosity of the gel. One concern our patients have regarding long term safety is the risk of rupture or
leaking from silicone implants. In the studies that were presented to the FDA, the rupture rates were acceptable
low at approximately 8% over 11 years for Allergan implants. The US FDA stipulates that routine MRI scanning of
all patients with silicone gel implants should be performed after 3 years and then every 2 years thereafter.
This will provide valuable information regarding a possible silent leak or rupture which might otherwise be
asymptomatic. It is very important as with all medical tests, that the information be interpreted by the
patients own surgeon. The decision as to what to do with the information should be handled as “shared decision
making” between the patient and the surgeon. Although these routine screening MRI’s are safe, quick and easy,
they are usually not covered by insurance. To help encourage women to get screened, I have worked closely with
the Conejo MRI group in Thousand Oaks, to obtain discounted rates for silicone implant patients. Any woman who
has had her silicone implants more than 3 years should have a screening MRI and then have the results reviewed
by a Board Certified Plastic Surgeon. Both implant manufacturers warranty the implants for life and most will
contribute something to the cost of replacing ruptured implants.
In summary, we are very excited to be using silicone gel implants for the last two years now with the approval
of the FDA. It is clear that many women are benefiting from the improved feel of the silicone implants which are
very natural. As with any medical procedure, regular follow up with your plastic surgeon on an annual basis and
screening MRI will insure long term safety. For women considering breast augmentation, a candid discussion with
a Board Certified Plastic Surgeon will help you decide which type of implant is better for you. Generally
speaking, silicone implants are particularly beneficial for ladies who are very thin as they will have little
breast tissue or fat to cover a saline implant. In short, the confidence provided by multiple studies, improved
patient education materials, and heightened awareness have helped patients and surgeons understand and feel
comfortable with the decision to use silicone gel filled breast implants. Regular follow up and MRI screening
will help insure long term safety and happiness for our patients.