The Facts About Textured Breast Implant Recall

Doctor holding stack of textured implants

The recent news that a specific type of textured breast implants is being recalled prompted a flurry of phone calls from breast augmentation patients to our Louisville practice. I’m sure plastic surgery practices across the nation fielded similar calls from women concerned about the recall.

We understand the concerns expressed by our patients, but misinformation is creating an unwarranted sense of panic. Dr. Mays and I believe that educating patients about the facts of this voluntary recall will help alleviate these concerns and provide our patients with peace of mind.

What You Should Know

First, it’s important to understand that this recall was voluntarily implemented by Allergan, not the FDA, and affects an extremely small percentage of women in the U.S. More than 90% of breast augmentation patients have smooth implants. And of those who have textured implants, not all have the specific Biocell textured implants that are the subject of the recall.

Allergan decided to announce this recall even though the FDA earlier this year decided there was no reason to take action after holding hearings regarding the incidence of a rare lymphoma condition that has been linked to textured implants called BIA-ALCL.  As chair of the American Society of Aesthetic Plastic Surgery’s task force studying BIA-ALCL, I testified at the FDA hearings in March. My expertise on the subject led me to publish an article in the Aesthetic Surgery Journal in January 2018 titled, “Safety of Smooth and Textured Silicone Breast Implants.” It was awarded the best article in ASJ in 2018.

Get the Facts

Below are answers to common questions about this recall. In addition to this blog post, Dr. Mays and I have posted a video on the CaloAesthetics® Facebook page for our patients to view. We have also scheduled 2 free, informational seminars for people to get the truth about this implant recall. Anyone is welcome to attend, even if you’re not one of our patients. The meetings are scheduled for Aug. 15 and Sept. 12, from 5 p.m. to 6 p.m. You can text or call (502) 899-9979 to RSVP for either seminar.

What is BIA-ALCL?

Breast Implant-Associated Anaplastic Large Cell Lymphoma is a rare type of lymphoma that is highly treatable, especially when detected early. It is not breast cancer. Women with Biocell® textured implants have a 1 in 2,200 chance of developing BIA-ALCL, a 1 in 80,000 chance with Siltex®, and even less of a chance with other textures. In contrast, 1 out of 8 women gets breast cancer. No studies have linked smooth implants with BIA-ALCL.

Does the recall mean I need my implants removed?

Not necessarily. This recall only means Allergan’s Biocell textured implants are no longer available for use. These implants account for less than 5% of all implants placed in the U.S. Patients don’t need to take any action unless they want to schedule an appointment with a plastic surgeon to ask questions and have ongoing evaluations. Having said that, Dr. Mays and I are advocates for our patients and, after understanding all of the facts and risks, a patient wants her implants removed, we will certainly provide that service.

Will Allergan pay for implant removal?

Because this recall only affects the sale of implants, implant removal (explant surgery) is not paid for by Allergan. Allergan will, however, provide free implants for anyone wanting their Biocell implants removed and replaced with Allergan smooth implants.

How do I know what type of implants I have?

Plastic surgery practices provide patients with a card that includes information about their implants. If you don’t have that card, your plastic surgeon should have the information on file. On a single day after the announcement of the recall, we had more than 20 patients call to ask about the types of implants they have. That’s understandable, but there is absolutely no reason for patients to panic.

Again, if you have additional questions or concerns you should contact our office or plan to attend one of the seminars mentioned above. I also encourage scheduling annual exams as an excellent way to ensure early detection of any issues associated with textured implants. I want to close by emphasizing that breast implants are safe and have changed for the better the lives of millions of women, both for aesthetic reasons and for those patients using them for reconstruction after breast cancer.

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