by John B. Tebbetts, M.D.
Today, the FDA released the results of its lengthy and detailed investigation and analysis about a possible association between breast implants and an extremely rare type of lymphoma called ALCL. This investigation by the FDA has been ongoing for almost a year, as experts from the FDA and other medical disciplines reviewed all available information in the medical literature, compiling all published case reports in the medical literature.
According to the FDA’s report, the FDA is “exploring a possible link between breast implants and ALCL. “ ALCL is an extremely rare type of lymphoma of the immune system that can occur anywhere in the body, but has been found in 34 women worldwide who have breast implants, out of an estimated 5-10 million (FDA numbers) of women who have had breast implants.
The FDA’s report states:
1) “Because the risk of ALCL appears very small, FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled”,
2) “ALCL is lymphoma—not cancer of the breast tissue”, and
3) “If you have breast implants, there is no need to change your routine medical care and follow-up.”
The vast majority of the reported cases of ALCL in breast implants occurred in patients who developed very large collections of fluid (seroma) around their implants more than 6-12 months following their augmentation surgery.
In my 30 year clinical experience with breast augmentation, treating thousands of patients, I have seen only 4 cases of seroma or fluid collection more than 12 months following surgery. None of those cases had ALCL. Two of the 4 cases developed low grade infection years after augmentation, with the specific cause undetermined.
Any mention of any type of tumor associated with breast implants understandably causes concern to any breast augmentation patient. My job as your surgeon is to evaluate the scientific evidence available, and provide my patients with my best evaluation of the evidence available. Exceedingly rare conditions occur in medicine, so constant vigilance; clear thinking, relying on science instead of opinion, and honestly communicating with patients are the principles that guide my practice.
Until there is more information regarding ALCL, what it really is, and what association between ALCL and breast implants can be proved scientifically, I recommend two things to my patients:
1) I agree with current FDA guidelines. If you do not have large fluid accumulations around your implants, or a breast mass that you can feel, you should be aware of information about ALCL, but not change anything about your current follow up or treatment. If scientific evidence changes, I will keep all my patients updated, and our recommendations may change based on that evidence.
2) If, for any reason, even if it is not based on scientific evidence that any physician should follow, your breast implants become a source of concern that outweighs their positives for you, you can elect to remove your implants. In the absence of medical evidence that documents a medically, scientific valid reason to put you through a surgery to remove your implants, I cannot recommend removal of implants as something that is medically necessary. Nevertheless, I understand that when your concerns, after consideration, outweigh any benefits you may have from breast implants, you may elect to have your implants removed.
I currently have an article under peer review in the most respected professional journal in plastic surgery, Plastic and Reconstructive Surgery Journal that outlines detailed diagnosis and management suggestions for the best breast augmentation surgeons of options for addressing late fluid collections in breast augmentation. The peer review process is essential and time consuming, and I will keep patients and colleagues updated on the information in that manuscript as the process continues.
The FDA’s summary report is here: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm240000.htm
The more detailed and comprehensive publication by FDA of their analysis is here:
About the Author: John B. Tebbetts, M.D. is one of the world’s best breast augmentation surgeons, with a track record of innovations and scientific publications about breast augmentation that is unmatched by any surgeon worldwide. For more information about breast implants or Dr. Tebbetts, please visit www.thebestbreast.com.