Prompted by collaborative research and data collection involving the American Society of Plastic Surgeons, the American Society for Aesthetic Plastic Surgery and other professional sources, the U.S. Food and Drug Administration (FDA) has requested that Allergan, a major worldwide manufacturer of breast implants and tissue expanders, recall all of their BIOCELL® textured surfaced breast implants and expanders as a precaution. The reason for this is that through meticulous investigations and studies, these particular devices have been shown to have an association, though rare, to what has been termed “breast implant associated anaplastic large cell lymphoma” (BIA-ALCL). Other implant manufacturers have also had their textured surfaced implants identified in some of these cases but present data shows that their rates are only about one sixth that of Allergan’s. It should be noted that the occurrence has been seen in both silicone and saline filled textured surfaced devices.
To place this all in perspective, extensive research and the usage of international databases has identified approximately 573 unique cases worldwide since 1996. This is out of a total implanted patient population of possibly 12 million or more women thus making it extremely rare. Anecdotally, this type of lymphoma has also been seen with other medical devices including dental and orthopedic implants.
In their recall, Allergan did note that textured surfaced breast implants comprised less than five percent of all of their implants used here in the United States. This is directly related to the fact that plastic surgeons and others using breast implants in this country select smooth surfaced ones a vast majority of the time.
To further clarify the situation and to set most women’s minds at ease, smooth surfaced silicone and saline implants have never been shown to have any association with the development of BIA-ALCL.
Only textured surfaced implants and most specifically the macro-textured ones produced by Allergan have been implicated. In this group are the once touted Natrelle® 410 highly cohesive anatomically shaped silicone-filled implants which are also known as the “gummy bear” implants.
From left to right: Smooth Surfaced, Textured Surfaced and Natrelle 410 (gummy bear) breast implants
I do want to let all of my breast implant and reconstructive patients know that for around the last twenty years or so, only around one to two percent of all the implants that I used were textured surfaced ones so that the odds that you have one are very low. If you no longer remember whether your implants had a smooth (clear surface) or textured (whitish and cloudy in appearance with a rough surface), you can refer to your saved (hopefully) implant card that was given to you by my office at the time of your surgery. This will have a model number which can be used to determine which type of implant it is. If there is any doubt, my office will help provide you with that information.
It is also important to understand that the FDA categorically stated that there is no reason to have these implants removed unless one is experiencing symptoms that could be consistent with BIA-ALCL. The most common of these symptoms are breast enlargement especially on just one side, pain, increased asymmetry, a mass in the breast or armpit, an overlying skin rash, breast hardening or a substantial fluid collection. The average time of appearance is around eight to ten years after implantation though it can be years earlier or later.
Importantly, realize that hardness of the breast, known as capsular contracture, is not an uncommon occurrence and has nothing directly to do with BIA-ALCL.
If you have any questions whatsoever about changes of your breasts related to your implants, it is recommended that you see a plastic surgeon for an evaluation. The odds are overwhelming, though, that if there is something going on it not likely to be BIA-ALCL.
For those women who have Allergan textured surfaced implants and are very anxious and worried about them and just want them removed, the company has just implemented a BIOCELL® Replacement Warranty in response to the recall. This program will provide you with smooth surfaced replacement implants absolutely free. It does not, however, cover any other costs associated with the surgery. For more information on this, you can check their website at www.allergan.com or contact your surgeon.
Steven H. Turkeltaub, M.D. P.C.
Scottsdale and Phoenix, Arizona