Allergan Textured Implants Recall
On July 24, 2019, breast implants manufacturer Allergan voluntarily recalled its line of textured implants and tissue expanders, as requested by the FDA. The recall was issued due to the increased risk of a patient developing BIA-ALCL, or “breast implant associated anaplastic large cell lymphoma,” a rare immune system cancer. While the cause of the cancer is not fully understood and more definitive research is needed, the recall cannot be ignored.
Textured implants were developed so that the implant was less likely to shift out of position or develop capsular contracture. The scar tissue that naturally develops around an implant (called a capsule) would be attached more thoroughly to the implant. As cases of BIA-ALCL were reported, it became clear that textured implants may have triggered the development of this rare cancer in some patients, at an average of 8 years after the implants were placed, but was found to occur as early as 2 and as late as 28 years after augmentation.
Are you concerned about BIA-ALCL? We can help.
If you have textured implants and are concerned about developing BIA-ALCL, we urge you to schedule an appointment to discuss your options. It should be noted that when caught early, BIA-ALCL is curable, so any symptoms should be evaluated immediately. If you opt to have your textured implants replaced for your own peace of mind, we can help. The FDA does not urge people without symptoms to have their implants removed, but this is a matter of personal choice.
Dr. Hamawy at Princeton Plastic does not place textured implants in his breast augmentations but uses only smooth implants.
What should I do if I have textured implants?
Both textured implants and tissue expanders produced by Allergan have been recalled, the BIOCELL® line. If you had breast augmentation with these implants and are experiencing symptoms, it is important that you are tested immediately. BIA-ALCL, when treated early, is usually curable. If you have textured implants, whether developed by Allergan or another breast implant manufacturer, watch for these symptoms:
- You have unexplained breast swelling, which can develop years after your augmentation
- One breast appears larger than the other
- You notice a fluid buildup within the breast capsule
- You notice a lump on your breast or in your armpit
- Your breast has hardened
- You have developed a rash on your breast
How often has BIA-ALCL occurred?
The number of cases of this cancer are low, currently affecting about 1 in every 3,817 to 30,000 patients. It is vital that further research is conducted to discover what triggers the cancer in certain patients. Various theories exist, including genetic predisposition. Some theorize that the textured surface leads to ongoing inflammation, which eventually leads to the development of BIA-ALCL.
How can we help you?
If you have concerns about textured implants, we urge you to speak with us about your options. Textured implants can be removed and replaced with smooth implants – the only type Dr. Hamawy uses at his practice. It is natural to feel worried about your health if you have Allergan textured implants, and it is worth having a discussion with Dr. Hamawy. If you are currently experiencing symptoms, get tested. Breast swelling can occur due to various other conditions, so don’t assume you have BIA-ALCL, but it is important that you undergo testing to protect your long-term health.