Are Silicone Breast Implants Safe?

Richard H. Tholen, MD, FACS
Article by
Minneapolis Plastic Surgeon

The modern era in breast augmentation began with the development and surgical implantation of silicone gel breast implants in a woman in 1963. In the 30 years that followed, plastic surgeons worldwide used silicone-gel-filled breast implants for both breast reconstruction and elective breast enlargement in well over one million women. Saline-filled breast implants were also used during this time, but in only about 15% of all patients receiving implants.

Breast implants were developed and utilized for more than a decade before the FDA began regulating medical devices in 1976; the safe and effective use of silicone in these and other medical products such as pacemaker insulation, lubrication for insulin needles, chemotherapy tubing, and artificial joints was well-established before the FDA could evaluate all of them. Because silicone breast implants and many other silicone medical devices were already in use prior to 1976, the ongoing use of these products was “grandfathered” by the FDA without formal evaluation and approval. None of these other silicone medical devices has been made unavailable to patients, but lack of formal FDA evaluation and approval of breast implants came into public awareness in the early 1990s.

The lay media has been responsible for spreading a great deal of information and misinformation regarding breast enlargement in the past two decades. Many women remember tabloid and TV talk shows' focus on the supposed problems claimed to be associated with silicone gel implants. Despite a lack of scientific data supporting these concerns, in 1992 the FDA restricted the use of silicone gel breast implants in women requesting elective breast augmentation.

At no point have silicone gel implants ever been “taken off the market,” but until November 2006 their use required enrollment in the FDA study that allowed only eligible patients and plastic surgeons access to them under strict guidelines. Since the FDA restrictions in 1992, numerous scientific studies (over 30 in the past decade) have continued to show NO cause-and-effect relationship between silicone gel breast implants and autoimmune-type illnesses (such as rheumatoid arthritis, lupus, scleroderma, or so-called "human adjuvant" diseases). Since 1992, silicone gel implants have been used by plastic surgeons involved in FDA-approved studies for patients undergoing breast reconstruction, breast augmentation revision (in certain patients), breast lift, and for those patients with congenital breast deformities.

After exhaustive review of the previous nearly four decades of use, the FDA approved the use of saline-filled implants in May 2000.

Late in 2003, the FDA reviewed all of the available scientific data about silicone gel implants, including very detailed information from implant patients over the preceding decade, and heard testimony from patients, physicians, and researchers. The expert physician advisory panel to the FDA voted to recommend that the FDA approve the use of silicone breast implants for primary elective breast augmentation. However, the FDA deferred its decision, requesting “additional information” before granting approval.

In spring 2005, the FDA again revisited the request by both of the existing U.S. implant manufacturers for approval of general use of silicone gel implants; the expert physician advisory panel recommended approval for Mentor Corporation’s gel implants. Late in 2005, Both Mentor and INAMED® received letters of “[gel implant] product approvable” from the FDA.

On November 17, 2006 the FDA approved the use of silicone gel implants from both companies in patients over the age of 22, with certain restrictions, including involvement in the FDA study that has been ongoing for the past several years.

Opponents of silicone gel implants continue to claim that they cause autoimmune illness or are unsafe, but peer-reviewed scientific studies by many researchers and institutions have shown them to be safe and effective for their intended use. The controversy about silicone gel implants has made them one of the most intensely studied products in the entire medical marketplace.

As part of the 2006 FDA reapproval of silicone gel implant use, each company has an informed consent booklet that prospective breast enlargement patients are asked to read (and sign). The FDA has made a controversial recommendation that patients with silicone gel implants undergo a MRI (magnetic resonance imaging, a non-X-ray study similar to a CAT scan) every two to three years to evaluate their implants (for leakage or rupture). Studies have shown that MRI evaluation of silicone implants has 79% effectiveness in detecting otherwise-unsuspected implant rupture or “leak.” Thus, if you have no identifiable problem or concern with your implants and choose to follow this recommendation, you will require an unnecessary reoperation (for entirely normal non-ruptured) implants 21% of the time! The FDA makes this recommendation because physician examination has been shown to be unreliable in detecting silicone implant rupture. Yet, since present silicone implants are cohesive and cannot “leak,” this is a nonsensical recommendation for patients with the latest generation of silicone breast implants. Patients with older silicone implants may find this recommendation appropriate, though still potentially misleading over 20% of the time!

Many plastic surgeons believe (and I am in this group) that if you are not having any kind of problem or concern with your implants, it is ridiculous to perform a costly (may not be covered by your insurance) and often-inaccurate test that would require an operation (erroneously) over 20% of the time. Rather, if you have any issue at all with your implants (size, shape, position, firmness, or concern about possible rupture), return to your plastic surgeon for evaluation. Your plastic surgeon can then do whatever corrective surgery is needed, where he or she will be able to examine, and replace if necessary, your implants under direct vision.

So, are silicone breast implants safe? In a carefully-considered word: “Yes.”

. . . More so than driving a car.

. . . And substantially more so than smoking, which curiously, the FDA has never banned despite overwhelming evidence of the health care risks that accompany tobacco use!