Breast Implant Safety

For women looking into breast implants, either for reconstruction after surgery or for breast enlargement, here’s a rundown of the latest information about breast implant safety and risks.

Breast Implants: The Basics

There are two general types of breast implants available in the U.S.: saline and silicone.  Both consist of a silicone outer shell; the difference is what’s inside the implants.  Saline implants are filled with saline, or sterile saltwater.  Silicone breast implants are filled with silicone gel. The FDA has given approval to two companies to make both types of implants, Mentor and Allergan. 

While other varieties of implant are being studied -- like the cohesive silicone “gummy bear” implant – other implants haven’t been approved by the FDA and are only available to women who enroll in a clinical trial.

Silicone Breast Implants: What Happened?

Silicone breast implants have attracted a lot of controversy since they were first introduced in 1962.  Back then, the FDA did not evaluate medical devices for safety. 

During the 1980s, the popularity of silicone breast implants surged, but so did accounts of their supposed risks.  Many people claimed there was a link between the silicone gel from ruptured implants and an increased risk of immunological disorders (like lupus and rheumatoid arthritis), fibromyalgia, and other conditions.  Some women reported that their symptoms went away after the implants were removed.  Some filed lawsuits against implant manufacturers.

While no studies established a firm connection, the FDA looked into the issue and, in 1992, restricted the use of silicone breast implants to women having reconstruction after breast cancer surgery. For the next 14 years, women who wanted breast augmentation had to use saline breast implants.

Then, in 2006, the FDA reversed course and approved the sale of silicone breast implants.  What changed? Numerous studies conducted during the 14-year moratorium found no real connection between silicone implants and disease.  The implants were deemed safe and effective.  However, the FDA still required that the two manufacturers conduct studies of their safety for the following 10 years to look at the long-term effects.

Breast Implant Safety: Which Is Better?

According to the current research, there aren’t significant differences in the safety of silicone and saline implants.  But each type of breast implant has its pros and cons.

• Ruptures.  Ruptures are a risk with either kind of breast implant.  Ruptures might be caused by surgical error, or a fall, or even -- very rarely -- the pressure exerted on the breast during a mammogram.  But the implications of a rupture are a little different for the two types.

o        Saline implant ruptures are easy to spot. The breast rapidly changes shape over days as the fluid leaks out.  If a saline implant breaks, all that leaks out is saltwater.  The saltwater is harmlessly absorbed into the body.