Breast Implant Associated ALCL (BIA-ALCL) is a form of lymphoma seen in women who have breast implants. ALCL is not breast cancer, it is a rare type of cancer of the immune cells. While all women with breast implants, or considering breast implants, should know about BIA-ALCL, it is extremely rare, very treatable, and should not be a major source of concern.
Below are a series of frequently asked questions and answers. Plastic Surgery professional organizations recommend that if you have any concerns or questions that you return to the original surgeon who performed the breast implant surgery, or to another board certified plastic surgeon.
You may find a list of board certified plastic surgeons at find.plasticsurgery.org
Q: What happens if I get BIA-ALCL?
A: It’s very unlikely that you’ll develop BIA-ALCL as it’s quite rare, so first, don’t worry! When identified early, the problem is usually very localized, and treatment is limited to removing the tissue immediately around the breast implant, called the implant capsule. While this is a surgical procedure, it usually does not impact the breast tissue, and with replacement of the breast implant, there is usually limited to no change in the appearance of the breast. Monitoring by a cancer specialist, is necessary, but frequently, no additional surgical treatment, radiation, or chemotherapy will be required.
Q: What is the risk of developing BIA-ALCL if I have breast implants?
A: The most recent count of reported cases worldwide is 457. There are unquestionably cases that have not been reported, but based on careful analysis, the risk has been calculated as somewhere between 1 in 2,800 and 1 in 82,000 for women with breast implants. But there is an important point to understand. Based on current knowledge and careful review of all the reported cases, there is a clear dividing line: To date, there have been no confirmed cases of BIA-ALCL in women with smooth surfaced implants. Textured implants, implants that have a surface that feels like sandpaper, are the only type of implants associated with BIA-ALCL. And it also appears that the rougher the texturing, the greater the risk. So, depending on your implant texture, the risks change. Smooth implants appear to have zero (or very close to zero) risk. Lightly textured implants – 1:82,000, Moderate textured implants – 1:3,200, and Aggressively textured (Polyurethane coated) implants – 1:2,800.
In many countries, sale of textured implants is no longer allowed. The FDA has allowed textured implants to continue to be sold in the USA, but Allergan, one of the companies that produce one of the moderately textured implants, has decided to stop selling these implants, and has recalled all unused textured implants. Polyurethane coated breast implants have been off the market in the USA for over 20 years.
Q: Is BIA-ALCL fatal?
A: As of July 24, 2019, the FDA has reported that there have been a total of 33 confirmed deaths world-wide (13 in the United States) related to BIA-ALCL since the disease was first reported 20 years ago. Most patients are treated with a relatively simple surgical removal of the non-breast tissue surrounding the implant, and require no further treatment other than monitoring.
Q: How do I know if I have BIA-ALCL?
A: Usually, physical signs, such as enlargement of the breast with fluid, along with pain, are the first signs. While all patients with breast implants should be routinely examined annually by a plastic surgeon or other physician, if you have any sudden changes in your breast, you should be seen by a plastic surgeon immediately. The surgeon will then evaluate you and possibly recommend a needle aspiration of fluid, or a biopsy. Laboratory examination of the fluid or tissue will confirm or rule out BIA-ALCL.
Q: What if I don’t have those physical signs – am I certain I don’t have BIA-ALCL?
A: Cases of BIA-ALCL have been associated with these physical signs, however in interviewing and reviewing all the cases of BIA-ALCL, it cannot be said with absolute certainty that if you don’t have these signs, you don’t have BIA-ALCL. If you have any concerns, you should be seen by a plastic surgeon.
Q: Are there any types of implants that are associated with a higher risk of BIA-ALCL?
A: As described earlier, breast implants that are textured (rough on the outside) have a much higher risk than implants that are smooth. There appears to be no difference in risk between saline and silicone gel implants. Size of implants, placement in front or behind the muscles of the chest, and the incision used to place the implant have not been shown to alter the risk. BIA-ALCL has been seen both in patients who have had cosmetic breast surgery and reconstruction for mastectomy.
Q: How do I know if I have textured implants?
A: At the time of your surgery, your surgeon may have given you a card, or some other form of information, indicating the implant manufacturer, model number and size. With this information, you can determine the type of implant. If you do not have the information, you can contact the surgeon who performed the surgery. There is no way to know if you have textured implants simply by examination, mammogram, or other imaging examinations.
Q: If I have textured breast implants, but no other problems, should I have them removed?
A: The recommendations by the FDA and plastic surgery professional organizations is no. Textured implants are still sold and are considered safe. Keep in mind that even with textured implants, the risk of BIA-ALCL is rare. With lightly textured implants, I personally agree with the FDA recommendation. I feel that with moderately and aggressively textured implants, even in the absence of any symptoms, serious consideration should be given to removing the implants.
Q: Is there any blood test that I can take, or imaging test to make sure that I don’t have BIA-ALCL?
A: No. Only examination of fluid around your implant, or examination of tissue removed by biopsy, can determine if you have BIA-ALCL.
Q: I’m really nervous. Should I have my implants removed?
A: The risk of developing BIA-ALCL is extremely small. Surgery to remove the implants and surrounding tissue also has risks. Fortunately, it also appears that with treatment the risk of death is extremely small. Based on current statistics, and my personal opinion, I would definitely recommend against removing smooth implants. Mildly textured implants – probably not. Moderately and Aggressively textured implants – I’m leaning towards removal and replacement.
To the extent possible, I am reviewing the medical records of all our breast implant patients. I will be attempting to reach all breast implant patients on whom I’ve used textured implants. By our preliminary analysis, this appears to be less than 1% of all of my breast implant patients. All my breast implant patients have always been encouraged to return annually for a no charge annual check, and I encourage all my breast implant to follow my recommendation to be examined annually.
Take the Next Step
If you’d like to learn more about which breast implant or implant size is best for you then please schedule a consultation with Andrew Barnett M.D. to discuss your options today. Consultations are available in both our San Francisco and Walnut Creek offices. You may schedule for either location by calling (415) 943-0749. Renee or Laurie will help you and answer any pre-consultation questions you may have!
*Individual results may vary.