Anaplastic Large Cell Lymphoma and Breast Implants
On January 26th, the FDA issued a Medical Device Safety Communication regarding Anaplastic Large Cell Lymphoma (ALCL) and Breast Implants. The possible connection between the two first came to my attention in the Spring of last year when Dr. Garry Brody presented a review of 34 cases of ALCL at the American Association of Plastic Surgeons meeting here in San Antonio.
The association is not clear cut and is confusing to Plastic Surgeons and the FDA so it must be very confusing to patients. Let me try to explain where we stand now. ALCL is a very rare type of cancer that can be found throughout the body in any person. It is not a Breast Cancer but is a form of Lymphoma that seems to respond well to treatment. Dr. Brody did an exhaustive search of the literature and contacted all of the authors of the reports to see if he could find a common cause among all of these cases, but he could not. The FDA has done a review as well and has even looked at the world wide incidence of this cancer and cannot reach any conclusions other than we should be very vigilant for it in women with breast implants. It is estimated that between 5 and 10 million breast implants have been placed worldwide, but only 34 cases of ALCL have been confirmed in women with breast implants. That puts the odds of having ALCL in women with breast implants at about 3 to 7 in a million. The FDA’s review has not found that there is a specific type of implant or patient involved.
In all cases, the women were having some type of trouble with their implants. Most of them were suffering from a seroma (a collection of fluid). Treatment has varied from simply taking out the implants and the associated capsule to removal and chemo and radiation therapy. The fact that some patients have done fine with mere removal of the capsule suggests that this may not be a cancer at all, but just an intense inflammatory reaction to the implant.
So what should you do if you have breast implants? Close monitoring is all that is recommended at this point. If you develop a fluid accumulation around your implants then we will need to send some of the fluid off for studies. I have always encouraged all of my patients with breast implants to come in yearly for an exam. As far as I know, I am the only San Antonio Plastic Surgeon who provides this extensive follow-up as part of the surgical package. This visit is usually a short one where I do a quick exam and take some photos, but can be invaluable if we find something unusual. I have not seen a case of ALCL yet and I have been looking very carefully since Dr. Brody presented his paper last year. We will continue to monitor the research and I plan to participate in the registry that the American Society of Plastic Surgeons has developed with the FDA.
I want to stress at this point there is no evidence that there is a cause and effect relationship between breast implants and ALCL. The FDA recommends only that women with breast implants should monitor their implants and contact their doctor if there are any changes. The FDA believes that current data supports the continued use of breast implants.
I will continue to ask all of our breast implant patients to follow-up with me annually. I know it may be an inconvenience for your busy schedules, but this quick exam helps me keep an eye on how you are doing and if any special tests may be needed.
