Silicone Gel Breast Implants: Are They Really Safe?
Silicone gel breast implants feel more natural and ripple less than saline implants. But are they safe?
Silicone gel implants were introduced in 1962 and were very popular in the U.S. for three decades. However, in 1992, the FDA (U.S. Food & Drug Administration) placed restrictions on the use of silicone gel following multiple reports of autoimmune diseases (such as arthritis, fibromyalgia, and lupus) reportedly linked to silicone gel. As a result, when I did my plastic surgery residency at Parkland Hospital in Dallas from 1992 to 1994, we took out many more implants than we placed. Of course, there were also $3 billion of lawsuits against the silicone gel implant manufacturers.
For the next 14 years, silicone gel became the most thoroughly studied substance on earth. Despite multiple attempts to induce a reaction to silicone gel in lab animals, no inflammatory response could be incited. Human studies failed to demonstrate silicone antibodies. The American College of Rheumatology (rheumatologists treat autoimmune diseases) subsequently concluded that there is no demonstrable link between silicone gel breast implants and any autoimmune disease process.
In November 2006, the FDA reversed its 1992 decision and approved Allergan (formerly Inamed) and Mentor silicone gel implants for use in the United States. However, the FDA has attached some strings to the use of silicone gel. While there are no age restrictions for saline implants, silicone gel breast implants are only allowed in woman ages 22 and up. In addition, the FDA has stated that while intact silicone gel implants are safe, the safety of ruptured silicone gel implants has not been conclusively established. Therefore, the FDA recommends MRI (magnetic resonance imaging) studies of the breasts at 3 years postoperatively and every 2 years subsequently. These studies are expensive (at least $1500) and are not covered by insurance. As a result, most women are choosing not to undergo regular MRIs postoperatively.
Given the fact that the manufacturers offer a 10-year implant warranty that covers most or all surgical costs if the silicone gel implants rupture, an MRI prior to your 10-year implant anniversary is probably a good idea. Better to have the manufacturer pay the cost of replacing a ruptured implant than pay it on your own.
So is silicone gel safe? If the implants are intact, the FDA says “Yes.” If they’re ruptured, the FDA says “We’re not really sure.” I personally do not think that silicone gel is an evil substance. As long as you understand that there is still some residual controversy surrounding silicone gel, I think it’s very reasonable to use. If silicone gel implants scare you, then saline breast implants remain an excellent alternative in most women.
For more information about breast implants, please visit my website.
Ronald M. Friedman, M.D.
Director, West Plano Plastic Surgery Center
Former Chief of Plastic Surgery, Parkland Memorial Hospital, Dallas