A Letter from Dr. Constance Barone On Textured Implant Recall
On July 24, 2019, the implant device company Allergan issued a recall on BioCell textured implants and tissue expanders.
This was done based on concerns that TEXTURED implants are associated with a very rare type of cancer called BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma) that can occur in and around the tissue surrounding a textured implant. Breast Implant Illness (BII) is not the same as BIA-ALCL and is currently not a disease recognized by the FDA nor the subject of this recall.
It is important to stress that ALCL is extremely rare, even if someone had reconstruction or augmentation with textured implants or tissue expanders.
To date, 573 cases of BIA-ALCL have been described worldwide, which includes 33 deaths related to this specific type of ALCL out of the approximately 25 million women in the world with breast implants. Fortunately, if caught at the first sign of swelling, BIA-ALCL is curable by removing the implant and the connective tissue capsule that forms around the implant.
So what does this mean for you?
Currently, given how rare BIA-ALCL is, the U.S. Food and Drug Administration (FDA) does not recommend removing textured implants for prevention only. Instead, it is important to follow-up regularly with your plastic surgeon: either with Dr. Barone, or another board-certified plastic surgeon. (If you need help finding a board-certified plastic surgeon near you, please visit the American Society of Plastic Surgeons website at https://find.plasticsurgery.org.)
What should you be on the lookout for?
Signs and symptoms of BIA-ALCL include swelling, pain, asymmetry, or lumps or masses. Though gradual changes in breast shape do occur over time with time and gravity, any changes that seem abnormal, sudden, or strange should prompt a call to our office so we can schedule you to come in for a check-up. The vast majority of the time, these findings do not represent anything serious; however, it is always smart to be vigilant and follow-up.
Your health and safety are and always have been the most important thing to me, as your plastic surgeon.
Please feel welcome to call my office with questions or concerns. Our Telephone number is (210) 614-0400.
Please remember to keep your implant card information that Dr. Barone gave you in a safe place. If you currently have a SILICONE (not a saline) breast implant, textured or smooth, remember the FDA currently recommends removal and replacement every ten years and to get an MRI at 2 years and every 3 years post silicone implant surgery. Lastly, please be aware that according to the Texas Medical Board, charts can be destroyed after 7 years of your last visit so please be sure to maintain your implant information in a safe place and bring it in with you for any follow-up visits or revision surgery you may be considering.
Given the above information, it is always a good idea to follow-up with your plastic surgeon with any concerns and to do a yearly follow-up visit.
Please do not hesitate to reach out to me with any questions or concerns.
Warm regards always,
Constance Barone, M.D
To download or print a copy of this letter, click here.