The FDA this past week has alerted the general population of a POTENTIAL risk between breast implants and a rare form of Lymphoma. The plastic surgery community brought this information to the FDA several years ago in an attempt to keep them informed of our current research into the effects of breast implants in general. As has been reported, the world has been scoured for cases of this extremely rare form of Lymphoma and only a handful of cases have been found. Because the numbers are so small it is extremely difficult to determine the epidemiology surrounding the disease and produce any meaningful conclusions. We are doing nothing more than sharing some observations of what is known without saying that the two are actually related. These few cases have been described with textured surface implants which are, by far the least used type of implant in the United States. The current state of implant manufacture is such that the shell used to contain the contents of the implant is far superior to the implants from years ago and the most widely used implants in the United States are smooth walled implants that have not been associated with the disease. Over the last two decades there have been over a dozen comprehensive studies performed looking at the possible links between breast implants and systemic diseases and none have been found! This fact should be very comforting to both the general public and plastic surgeons alike.
To further put into perspective the concept of risk a few facts will be of help. First, the risk of a women developing ALCL in the United States is about 1 in 500,000 if, in fact there is a connection between breast implants and ALCL that risk, based on 3 cases in 1 million women, would increase to 1 in 333,333 women. It is a well established fact that approximately 1 in 8 women will develop breast cancer in the United States and that that number is irregardless of the fact of whether they have breast implants or not, that is, the risk is the same for women with implants as those without implants. The second thing that is sometimes difficult for people to get a perspective of is what these numbers really mean. Very few people, save epidemiologist who deal with these numbers every day, can really get a feel for the difference in risk between 1 in 500,000 and 1 in 333,000. One way to look at this is to compare it to other risks so I am going to add some statistics here that I hope will help people do this.
Cause of Death Lifetime Odds
Heart Disease 1 in 5
Cancer 1 in 7
Car Accident 1 in 100
Electrocution 1 in 5,000
Air Travel 1 in 20,000
Lightening 1 in 83,930
Hit by Asteroid from Space 1 in 500,000
We are all concerned for the safety of our patients and always err on the side of “Do No Harm” but, we also have an obligation to use common sense and reason in making our decisions.
I hope this helps in providing some small insight on perspective.
