Fifty Years with Silicone Gel Breast Implants. What’s on the Horizon in 2016? [Part 5 of 5]

As I began this series, we have come to a new chapter in the use of the silicone gel breast implant. The chapter actually began in 2006 when the FDA released silicone gel back into the U.S. market for breast augmentation. The silicone “crisis” never reached other countries in the world, only the U.S. with its very unique legal system. When implants were released, there were new product warnings, labeling, follow-up recommendations, age restrictions, and the requirement for an additional 10 years of post market studies to add to the already burgeoning implant research data. But what did we truly learn from the past experience? Breast augmentation remains a very popular procedure with very high satisfaction rates. Those who choose breast augmentation will most likely wear implants their entire life. Satisfaction is so high that most would prefer never to even think about their breast implants, and even forget to mention them when they have a mammogram. Herein lays the problem; all breast implants will wear out and need replacement. We repeat the need for implant maintenance, the value of MRI tests, importance of the ‘ten year’ check, though is everybody listening? Everyone wearing a silicone gel implant should keep the implant identification card, keep in touch with a surgeon for check ups, and know all good things come to an end, and for most, new implants and a new beginning. Implants will have a significant, though low leak rate at ten years of perhaps 8%, so I have marked my calendar for 2016; just ten years after silicone gel implants came back and hit the ground running. This could be critical year, if we have not learned from the past one. Remember, your breast implants will not make you sick, and do not cause cancer, and will not explode in your chest, but they will eventually leak, each and every one of them. When the news comes on in 2016 and newscasters break the story, remember you heard it here first. Let’s not panic, no shock and dismay, just out with the old ones and in with the new. Ten good years is, well, ten very good years. By then, the silicone gel implant will turn 54, and no doubt will still be the most studied medical device in the world.

Silicone Gel Breast Implants Turn 50 [Part 1 of 5]

The most studied, and yes, the most litigated device in medical history, is set to turn fifty years of age with the coming of spring 2012. Despite the tempestuous course, breast augmentation and the rise of the silicone gel breast implant has been an exciting story and remains the second most popular cosmetic surgical procedure in the US, and the number one procedure in Europe, with well over two million women wearing breast implants world wide.

The silicone gel breast implant was first conceived by two surgeons in Houston Texas, Thomas Cronin and Frank Gerow. They confronted a demand for a safe means to enlarge and enhance the breast, a challenge with a very long history. We may think that the current youth-oriented society and the fashion industry are responsible for the demand, but the quest for a full and attractive breast is documented in late 1800’s with advertisements for breast creams and suction devices to enhance breast size. Surgical breast augmentation was tried in the 1920’s with glass beads, paraffin, fat grafts (yes, we are back at it), and later a sponge material which was used up until the 1950’s. The hardships from these attempts were well known to Dr.’s Cronin and Gerow, as well as knowledge of the introduction of silicones in the 1940’s during the war. Reports were circulated of a home remedy used by Japanese prostitutes of paraffin and industrial silicone injections to enlarge the breast. Though very many resulted in infection and terrible cysts, some were soft enough to warrant the concept of containing the silicone in a balloon or pillow and thus the idea of the silicone gel implant was born.

It was the spring of 1962 and the first silicone gel implant breast augmentation was performed on Timmie Jean Lindsey in Houston Texas, and later presented at the International Society of Plastic Surgeons in Washington DC in 1963. Mrs. Lindsey is alive today and has been noted to have enjoyed her procedure for decades. The success, fame and fortune of Dr.’s Cronin and Gerow are almost of legend, and were chronicled in a semibiographical film ‘Breast Men’ in 1997 directed by Lawrence O’Neil. Though the movie is not completely factual, it offers a rather comical look into the meteoric success of cosmetic breast enhancement. At last, plastic surgeons had the “prefect” solution to augmentation of the breast in a safe and affordable way.

The rest has been history, though what a history it has been. Dow Corning manufactured and distributed the widely popular silicone gel breast implant enjoyed by many. And though reports of silicone bleed and implant rupture surfaced, the implants had a very good run for the next 20 years.

When I began to enter plastic surgery in 1979 the FDA had just begun collecting “safety and efficacy” data, and as surgeons we knew about eventual leaks and capsular contracture, but patients expected implants to last a lifetime. We had set ourselves on a collision course of public misunderstanding and this is where the story about the silicone gel breast implant really takes off. More in my next blog.