Breast implants have been around for almost 50 years and no product has been tested more by the FDA.
So when the FDA re-approved silicone implants for general use in 2006, plastic surgeons and patients alike were understandably reassured about the safety and efficacy of breast implants. Then came a small announcement called “Preliminary FDA findings and analyses” documenting 13 years of literature on ALCL. ALCL doesn’t sound as scary as the Rheumatoid arthritis/Scleroderma/Adjuvant disease worries of the 1990’s but it stands for Anaplastic Large Cell Lymphoma. Very scary. A closer look at the evidence shows this type of lymphoma is exceedingly rare. 3 in 100 million women per year will contract the disease. In women with implants the disease has been identified and increases to 34 women after an estimated 10 million implants placed worldwide. A little bit of fuzzy math tells us your about 10 times more likely to get ALCL if you have implants than if you don’t. But how afraid should women be of getting ALCL from implants? Not very, as some quick comparisons with other risks that we regularly run in our daily lives indicate. For example, in 2003 about 45,000 Americans died in motor accidents out of population of 291,000,000. Your lifetime probability (6500 ÷ 78 years life expectancy) of dying in a motor accident are about one in 83. What about your chances of dying in an airplane crash? One in 5,000 lifetime risk. What about walking across the street? A lifetime risk of one in 625. Drowning? One in 1100 lifetime risk. In a fire? About the same risk as drowning. Murder? A lifetime risk of one in 210. And the proverbial being struck by lightning? A lifetime risk of one in 80,000. And what is the risk that you will die of a catastrophic asteroid strike? In 1994, astronomers calculated that the chance was one in 20,000. However, as they’ve gathered more data on the orbits of near earth objects, the lifetime risk has been reduced to one in 200,000 or more. Finally some good news.
All kidding aside. At this point we are still offering implants to patients in good faith. However, I personally am exploring options for augmentation and reconstruction of the breast using Large Volume Fat Grafting. No matter what you choose all options should be on the table.
– Rafael C. Cabrera, MD, FACS