Allergan Implant Recall

July 25, 2019

Dear Patients,

I am writing this letter as a reminder to all of our patients who have had breast surgery with implants – either reconstructive or aesthetic – to maintain regular, yearly follow-up appointments. There is no visit-charge for our cosmetic patients’ annual breast implant follow-up visit at our office.

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 Anacosmetic Large Cell Lymphoma) that can occur in and around the tissues around a textured implant.

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. This is out of 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 cosmetic surgeon: either with Dr. Lopez, or another board-certified cosmetic surgeon.

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 cosmetic surgeon.

Please feel welcome to call Aesthetic Laser Center any time with questions or concerns. If you currently have a breast implant, textured or smooth, please ensure you have a regular follow-up visit scheduled.

Linda J. Leffel, MD
Board Certified American Board of Plastic Surgery
Member American Society of Plastic Surgeons
Member The American Society for Aesthetic Plastic Surgery

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