New issues with breast implants: Should you be concerned?
Posted by Dr. Baxter
Breast implants are in the news again, with the US Food and Drug Administration having issued warning letters to two manufacturers, and hearings on renewed safety concerns are set. But before getting too caught up in the controversies of the moment, it’s worth looking at how we got here. Let me add at the outset that as a board certified plastic surgeon, I am first and foremost a physician dedicated to the healing arts. The safety and well-being of my patients is always a top priority.
Breast implants and I go back a long way. What is now known as the FDA moratorium on silicone implants hit soon after I entered private practice. Controversy prevailed back then, manifest by class action lawsuits against the manufacturers and a sense of panic among breast implant recipients. All of this was fueled by a lack of adequate information on the safety of silicone implants, so during the 14 years of restriction an enormous amount of research was done. In fact no medical implant of any type has undergone more intensive scrutiny. In 2006, they were approved by the FDA, with the requirement that manufacturers participate in ongoing surveillance, what is called a post-marketing study. The March 2019 FDA Warning Letters to Mentor and Sientra were based on criticism that the numbers of patients in long term follow up were inadequate. (I’ll get back to that.)
For those of us who have been doing this a long time, there’s a sense of déjà vu. Early concerns were based on a vaguely described syndrome of complaints thought to be a reaction to silicone or something else about the implants, in addition to more well-known autoimmune diseases. The latter was categorically ruled out in the studies of the 1990’s and early 2000’s, in that the incidence was exactly the same in large matched populations of women with and without implants. But now the “breast implant illness” syndrome appears to be mounting a comeback, with more and more patients and many plastic surgeons concluding that there may be something there. It’s an area of intense clinical research and interest, and equally intense debate about what it is and how best to treat it.
The bigger issue at the present may be a rare type of cancer called BI-ALCL (Breast Implant associated Anaplastic Large Cell Lymphoma.) This is a tumor that develops in the scar capsule around breast implants, and curable with surgical removal of the capsule if recognized early. As the numbers of reported cases grows, BI-ALCL has become an important safety concern. (I first wrote about this in 2010, reprinted below.) There is now an international registry for ALCL and well established treatment guidelines. It typically presents with fairly sudden onset of swelling around a breast implant 8-10 years after implantation, and is almost always associated with textured implants. It is more common than the 1 in a million original estimate; the number of known cases is worldwide is in the hundreds.
So what do we make of the Warning Letters? The answer is not so simple. Because these are post-marketing studies and not pre-approval clinical trials, the companies count on patients to sign on to be tracked and return for regular follow up evaluations. This is extremely difficult to do in the long term, because patients tend to want to get on with their lives, returning to their surgeons only if there is a specific concern. People move, change names with marriages and divorces, or simply value their personal privacy over the FDA’s desire for monitoring. Patients have to consent to be contacted. So while I do believe that the post-approval studies are important, we have to accept that 100% follow up for many years is not going to happen because that is not what many of the patients themselves want. What plastic surgeons want their patients to know is that we are listening, and we take these concerns seriously.
MONDAY, MARCH 8, 2010
Breast implant-lymphoma connection debated Although breast implants are without a doubt the most extensively studied medical devices on the market and are widely regarded as safe, a new report is raising questions about a possible connection between implants and a rare form of non-Hodgkin's Lymphoma called ALCL. Dr. Garry Brody, a Professor Emeritus of plastic surgery at USC, has been collecting a database about these rare cases, now totaling 25. Importantly, the tumor occurs in the scar capsule around the implants, not in the breast, and appears to be associated with a specific type of textured implant surface. A more important distinction is that these tumors behave in a very benign fashion and are highly curable by surgical removal of the capsule. This suggests that they are actually something other than ALCL despite the fact that they have all of the features of it under microscopic examination.
Although any report of cancer and breast implants is likely to be sensationalized, a cautious approach would be prudent in interpreting this story. In addition to the unanswered question of whether or not this is really a cancer, the incidence among women with implants appears to be in the range of one in a million, which could only be characterized as extremely rare. There will likely be other reports coming forth as the story is publicized, but given the number of women worldwide with implants, it is likely to remain a rarity. So in the good news column, place the fact that it is highly curable, and if it does have a causative link, it is to a type of implant that is less frequently used now (I have been using exclusively smooth-surface implants for augmentation for 15 years.) To keep this in perspective, it is the drive to the plastic surgeon's office that is the most dangerous part of breast implant surgery, not the implants.