1. Do I need to have my implants removed?
No, the FDA has specifically stated that implant removal is not necessary at this point unless you are diagnosed with BIA-ALCL. Having symptoms such as breast swelling, a lump in your breast or armpit, persistent breast pain, a rash or any change in your implants should be investigated by your physician. If you have any of these symptoms you should make an appointment to see your board-certified plastic surgeon and member of the American Society of Plastic Surgeons.
2. I have Allergan BIOCELL implants. What should I do?
Unless you are having the symptoms noted below, there is nothing to do at the present time other than routine continual breast examinations. Any changes in your breast should be examined and discussed with a board-certified plastic surgeon. The current recommendation from the FDA is that women with Allergan BIOCELL implants that do not have symptoms do not require removal. If you have Allergan BIOCELL implants, you should understand that textured surface implants are associated with a low but real risk of BIA-ALCL, a cancer of the lymphatic system. You should know the signs and symptoms of the disease. As long as you have your breast implant(s), you should monitor your breast area for any changes.
It is important to note that on September 12, 2019 the FDA released an update identifying Allergan BIOCELL Textured Breast Implant(s) as a Class I recall, the most serious type of recall. If changes to your breast(s) arise, you should seek evaluation promptly. More information about BIA-ALCL can be found at:
3. I have a textured implant(s) but my implant(s) have not been recalled. What is my risk for developing BIA-ALCL?
At the present time, your exact risk is not known. However, it appears to be significantly less than the risk noted below in question 4. The FDA and a 2017 study of US epidemiology of BIA-ALCL noted that Allergan BIOCELL implants appeared to be 6x more likely to be associated with the development of BIA-ALCL than other textured implants currently on the market.
4. What is my risk of BIA-ALCL? Is my risk of BIA-ALCL lower if I remove my implants and do not have them replaced?
The risk and incidence of BIA-ALCL in patients with Allergan BIOCELL textured implants ranges from 1:443 (median of 7 years) to 1:3345. The overall risk of BIA-ALCL in the US is 1:30,000 which is an average of several high and lower risk textured implants. There is no known procedure that can reduce risk for the development of the disease in the future. Patients have developed BIA-ALCL with a history of a retained scar capsule and a history of only simple implant exchange. However, patients should note that the current risks associated with any surgery are higher than the risk of developing BIA-ALCL. Discuss all benefits and risks with your board-certified plastic surgeon. Understanding all potential risk factors will help with better decision-making that is best for you and your health.
5. I had (or currently have) textured tissue expanders. Should I be worried? What is my risk of BIA-ALCL?
Risk of disease with tissue expanders has not been determined at this time. It is important to stay vigilant and upon noticing any changes in your breasts, consult a board-certified plastic surgeon.
6. Is there a screening test for BIA-ALCL?
At present there is no screening test or tool for BIA-ALCL. The best course of action is careful routine breast examination. If you have symptoms such as breast swelling, a mass in your breast or armpit, a new rash on your breast or persistent breast pain, or any change whatsoever in your breasts, you should see your plastic surgeon for evaluation.
7. I have symptoms of BIA-ALCL. What should I do?
The most common sign of BIA-ALCL is fluid or swelling around a breast implant. This usually happens many years after the implant was originally placed. BIA-ALCL can also cause tumors that arise from the scar capsule around the implant. Less commonly, BIA-ALCL can cause a breast to become lumpy or misshapen with the development of thick scar capsule around an implant.
If you have any of these symptoms of BIA-ALCL or other changes in your breast(s), your health care provider should evaluate you promptly. It is important to note that these signs and symptoms do not necessarily mean a diagnosis of BIA-ALCL. These changes, for example, can also result from a leaking implant or trauma to the breast area. To evaluate for BIA-ALCL, your health care provider will take your history, perform a physical exam and may order imaging or an assessment of any fluid or tissue around your implant.
8. If I choose to have my implants removed and/or replaced, do I need to have the capsule (scar around my implant) removed? What is an En-Bloc resection?
If you choose to have your breast implant(s) removed out of concern for BIA-ALCL, you should have a discussion with your surgeon about implant removal, implant exchange, and partial or total scar capsule removal. The surgical removal of the scar capsule around your implant is called a “capsulectomy” in an otherwise healthy patient. Having a total capsulectomy at the time of implant removal is not known to change the risk of developing BIA-ALCL. The risk of performing a capsulectomy includes, but is not limited to, bleeding and other wound complications. For reconstruction patients, a capsulectomy could result in a change of shape to your breast or loss of the reconstruction.
En-Bloc resection is often a misused term that means a cancer removal in a BIA-ALCL diagnosed patient with removal of the implant, complete capsule in conjunction with any associated mass and a rim or margin of surrounding healthy tissue.
9. I didn’t receive an implant card. How do I find out what kind of implant I have?
The best and easiest way is to contact the surgeon who performed your surgery or the hospital where you had your surgery performed and ask for your medical records. If your surgeon is no longer in practice or a significant time has elapsed since your surgery, the implant manufacturers may have this information through their device tracking mechanisms. Call the medical information division at one of the companies to find out about your implants.
10. Am I in the NBIR/PROFILE registries?
The aggregate NBIR and PROFILE registry datasets do not contain any personal identifying information. Contact your plastic surgeon and/or treating physician to determine whether or not your information was entered in either registry.
