Are Silicone Implants Safe?
If you have hesitated over silicone because of something you read years ago, you are not alone, and the evidence should reassure you. Silicone gel implants are FDA approved, and their safety has been studied extensively. A Swedish study conducted during the 1990s at the Karolinska Institute found no connection between silicone implants and breast cancer. To this day, there is no medical evidence linking silicone implants to autoimmune disease or cancer.
How Silicone Earned Its Approval
Silicone gel implants have a long regulatory history, and it is worth knowing. In the 1980s, the FDA restricted their use while questions about safety were studied. Through the years that followed, silicone gel implants were available only through FDA-monitored studies, so researchers could gather evidence on how they performed over time, well over a decade of study in all. In 2006, after reviewing that body of research, the FDA approved silicone gel implants for general cosmetic use.
Cohesive Gel: Safer by Design
The silicone implants used today are not the devices of decades past. Since November 2006, cohesive “gummy bear” gel implants, sometimes sold as MemoryGel, have used a filling so thick it behaves as a single unit rather than a liquid. Even if the outer shell is punctured, the gel stays in place and sticks to itself rather than leaking. That consistency also gives the implant a stable shape, with less chance of forming a lump, and silicone implants tend to be less likely than other types to harden or feel unnatural.
FDA Approved
Silicone gel implants carry FDA approval for cosmetic breast augmentation.
Cohesive Gel
A gel thick enough to hold together as one unit, so it won’t leak if the shell is punctured.
Holds Its Shape
The cohesive filling keeps a stable contour with minimal chance of forming a lump.
Years of Study
The FDA studied silicone gel implants for well over a decade before clearing them for use.
Understanding the Risks
No surgery is without risk, and breast implant surgery is no exception, complications can occur regardless of a surgeon’s skill or the care of the medical team. Being informed is part of making a confident decision. Surgical risks include reactions to anesthesia, which depend on your health and the type used, along with bleeding and infection. Both are rare and, when they occur, are usually easy to control. Some bruising can follow bleeding, but it is not typically harmful or a sign of serious trouble.
Implant-specific risks
Some risks relate to the implants themselves. An implant can rupture or leak as a result of injury or extreme pressure. Cosmetic irregularities such as dimpling, wrinkling, slight puckering, asymmetry, or visibility of the implant are also possible. Capsular contracture, when the scar tissue that naturally forms around any implant tightens, can cause firmness, slight distortion, and discomfort, and is more common following infection, bleeding, or fluid collection. A rare condition, anaplastic large cell lymphoma (ALCL), has been linked to breast implants, and specifically to textured implants; its signs include swelling, pain, and fluid around the implant. Dr. Roudner reviews your full health history and talks through every relevant risk before you decide.
Frequently asked questions
Are silicone breast implants safe?
Silicone gel implants are FDA approved. A Swedish study at the Karolinska Institute in the 1990s found no connection between silicone implants and breast cancer, and there is no medical evidence linking them to autoimmune disease or cancer.
What happens if a silicone implant ruptures?
Today’s cohesive gel is so thick that it holds together as a single unit. Even if the shell is punctured, the gel sticks to itself rather than leaking out, a meaningful improvement over older designs.
What is capsular contracture?
Scar tissue naturally forms around any implant. If it tightens, it can cause firmness, slight distortion, and discomfort. It is more common after infection, bleeding, or fluid collection, and silicone implants tend to be less prone to hardening.
Do implants cause a type of lymphoma?
A rare condition, anaplastic large cell lymphoma (ALCL), has been linked to breast implants, specifically textured implants. Signs include swelling, pain, and fluid around the implant. Dr. Roudner discusses this and every relevant risk during your consultation.
