Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Breast implants have been available since the 1960’s and have continued to increase in popularity. Over 300,000 women in the US have cosmetic implant-based breast surgery in the US every year, and another 150,000 have reconstructive breast surgery using implants. The safety profile of these devices has been excellent. In fact, even when the FDA took silicone implants off the market for a few years, it was ultimately determined they did not cause diseases, but instead had issues with durability. Once the device manufacturers fixed these problems, silicone implants were back on the market.  However, in 2011, a rare form of lymphoma began being diagnosed associated with breast implants. Affected women were developing swelling, fluid and masses around their implants, most commonly more than seven years after their original surgeries. Some even developed lymph node involvement or tumors in their chest wall. This disease is not a cancer of the breast, but cancer of the immune system. When it is diagnosed early, it is curable with the removal of the implant and the capsule around the implant. When it is diagnosed late, even surgery with chemotherapy and radiation added doesn’t always work, and there have been deaths reported.

When this disease was originally reported, the risk was said to be very low at 1/30,000 patients. Now it is reported as approximately 1/3000. That is quite a change in seven years. As registries were developed and information was disseminated to surgeons around the world, more cases were reported. Due to poor previous worldwide reporting and lack of global implant sales data, exact numbers are hard to come by, but suffice it to say, the number of cases reported continues to increase. In January of 2011, 64 cases had been reported. Five years later the total number had quadrupled. As of March of this year, that number had doubled again to 518 cases. The truth is, I don’t believe we actually know the total number yet. We do know there have been sixteen deaths, nine of which were in the US.

Before you get too alarmed, I need to emphasize this still remains a relatively rare condition. Also, very importantly, this condition has ONLY been diagnosed in patients who have had textured implants. In the US, only about 12% of implants placed are textured, and the remainder are smooth. In Europe the reverse is true, and the majority of implants are textured. Given this information, you might rightfully ask, why anyone would continue to use textured implants. I am asking that question too!

The reason given by surgeons that use them generally is that they think they get better results with textured implants. These rough surface implants were developed to decrease the incidence of scar tissue that can develop around implants called capsular contracture. The data is somewhat equivocal on whether they do or do not succeed in lowering that rate, but let’s say for argument sake they DO lower capsular contracture rates. Who cares?! If they are associated with cancer, I do not think we should still be using them. Not a single case of BIA-ALCL has been diagnosed in a patient that has always had smooth implants.

I was part of the audience at a national plastic surgery conference several years ago when a study was performed. All of the several hundred plastic surgeons in the audience were asked to vote on ten sets of pre and post-op photos as to whether we thought the implants used were textured and shaped, or smooth and round. We were wrong 52% of the time. No better than guessing. If well-trained plastic surgeons can’t tell the difference between results with smooth and textured implants, how much better can the results really be? Add to that– textured implants are firmer and more expensive.

Other leading reasons surgeons say they use textured implants are that they don’t stretch surrounding tissues and move out of position. My contention is that if appropriate size, smooth implants are used, they don’t move out of position either, especially if the pocket for the implant is created properly. Textured implants do occasionally move, in fact, the shaped or anatomic ones have been known to rotate in the pocket leading to a misshapen breast that sometimes requires surgery to correct.

Even if we accepted that textured implants provided better results (which I and the vast majority of plastic surgeons in the US do not,) and that the incidence of cancer associated with them is very rare, it is still CANCER we are dealing with. Once again, this cancer has never been associated with smooth implants.
I took an oath to first do no harm. I take those words very seriously, and I strongly feel surgeons should consider stopping their use of textured implants until we better understand the actual risks associated with them, and how to prevent this type of cancer from occurring.

Evidently, some well-respected researchers agree with me like plastic surgeon Mark Clemens, M.D. from MD Anderson Cancer Center, who is a leading researcher in this disease. He was recently quoted as saying it is unconscionable that surgeons are still using textured breast implants.

If you are seeking breast augmentation surgery, and your plastic surgeon suggests the use of a textured implant, ask if they can get as good of a result using a smooth implant; if not, seek additional opinions.

“Low risk” is not “no risk”, and the numbers of patients affected are still rising, meaning we don’t know the true risk associated with textured implants. Results of breast augmentation can be beautiful, and the procedure is a safe one. Learn your options and be an informed, educated patient. Most importantly stay healthy and safe.

Categorized in: