Should You Use Silicone Implants?

In November 2006, the FDA lifted its 14-year partial ban on silicone breast implants. Pre-filled silicone gel implants are now available for breast augmentation and reconstruction after mastectomy.

While breast reconstruction can be accomplished with saline implants, silicone offers more aesthetic benefits; it more closely mimics the weight and feel of natural breast tissue and is less likely to ripple or wrinkle.

Are they safe?

While the safety of silicone implants has been debated for years, silicone has a long history of medical use. Heart valves, skeletal prostheses, penile implants, and many other implanted medical devices made of silicone have been used for decades without similar controversy. None have been studied as much as silicone breast implants; none of the many comprehensive studies of silicone implants over the past two decades have found evidence that silicone implants cause cancer, arthritis, autoimmune disorders or other diseases.

The recently-approved gel-filled breast implants are quite different from products that were previously available. The new implants have three layers of silicone shell; the outer shell is thicker and the gel is more cohesive than earlier liquid-based silicone. If the implant ruptures, the gel holds together.

The agency also recommends regular MRIs for women with silicone implants-three years after the initial surgery and every two years thereafter-to detect “silent ruptures.” Women may be unaware their silicone implant has ruptured, because the breast may retain its shape. A saline implant, on the other hand, deflates completely when it ruptures. The breast loses its shape and the body simply absorbs the saline.

Under the terms of the FDA’s approval, plastic surgeons must discuss these issues with women who want saline implants, and provide the implant package information to patients before implant surgery.

The FDA approved silicone implants as “reasonably safe,” but observed that implants do not last a lifetime and will likely need to be surgically replaced at least once.

Over the next 10 years, Mentor and Allergan, the two companies that manufacture the approved breast implants, must each study 40,000 women who have silicone gel-filled implants to determine how safe and effective they are compared to silicone implants.