You may have heard that recently the FDA asked Allergan, the maker of the textured breast implant, to recall these implants. Doctors Heppe, Bautista, and Aflaki have studied the FDA request and the Allergan response, and we wanted to share our opinion so our patients with the textured breast implant can make an informed decision. Note that those with smooth surface breast implants (who make up the majority of those with breast augmentation) are not impacted by this recent recall.
The FDA Request
In late July 2019, the FDA asked Allergan to recall its textured breast implants from the global market after reviewing worldwide findings that connected textured breast implants to a heightened risk of or breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The Allergan textured implants have a BIOCELL textured shell, uniquely developed and only used by Allergan.
A full list of Allergan’s voluntarily recalled BIOCELL textured implants and devices available in the U.S. can be found at the end of this FDA release.
The Findings
The FDA recall was brought on by findings of 573 new worldwide cases of BIA-ALCL. Eighty-three percent of these cases (481 out of the 573) reported having Allergan breast implants at the time of diagnosis.
Based on these findings and other currently available data, the risk of BIA-ALCL for patients with Allergan textured implants is approximately six times higher than with implants from other manufacturers.
The FDA is continuing to evaluate these findings and has stated they will “take action regarding other breast implants, if warranted.”
What is BIA-ALCL? What Can Be Done to Treat It?
BIA-ALCL is not breast cancer.
Rather, it is a form of non-Hodgkin’s lymphoma: a cancer of the immune system. In most of the reviewed cases, BIA-ALCL is found in scar tissue and fluid near the implant though it can spread throughout the body if left untreated.
The good news is that the chance women with textured implants have of developing BIA-ALCL is just one in 30,000 which translates to a .003 percent risk. Again, this risk is predominantly for women with the Allergan textured breast implant.
Despite the low risk, if the disease is detected, immediate treatment is critical. Worldwide, 573 cases have been reported. Of these, 481 cases involved the Allergan Biocell implants.
For most patients, BIA-ALCL can be successfully treated with surgery to remove the implant and scar tissue surrounding it. In severe cases, however, patients may require chemotherapy and/or radiation therapy.
Patient Recommendations from the FDA
- If you aren’t showing symptoms, the FDA is not recommending removal of Allergan implants or other types of breast implants. The risk of developing BIA-ALCL is low. However, if you have questions, concerns, or think you may have symptoms talk to your health care provider or contact us.
- Learn the symptoms: persistent swelling and/or pain near the implant
- Monitor your breast implants and the surrounding area for any changes.
- If you experience any symptoms, talk to your health care provider immediately to discuss evaluation for BIA-ALCL.
- Keep a record of your implant’s manufacturer, unique device identifier, and implant model name. If you would like to obtain this information, contact us.
- Understand that most BIA-ALCL occur years after implant placement, talk to your surgeon about your risk of developing Breast Implant Illness.
- If you are considering breast implants, discuss with your surgeon any concerns, and follow their recommendations.
If you have concerns about the implants you have, we would be happy to talk to you about other options which may include:
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- Exchange your implants for another type of implant
- Removal of your implants
- Removal of implants followed by fat transfer to the breast.
Call us at 540-371-7730 to schedule your consultation appointment.
Questions about the Allergan Textured Breast Implant and Cancer?
If you have any questions about your implant or risk of developing BIA-ALCL:
- Talk to your health care provider
- Ask your surgeon for the records of your surgery and implant information to find out if you have an affected product
- To answer specific questions about the recalled products, contact the manufacturer, Allergan, at IR-Medcom@allergan.com or call 1-800-678-1605 option #2.
- For general questions about the recall, contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.
For any other issues, do not hesitate to reach out and contact us. We are committed to maintaining every patient’s safety and want to ensure you feel confident and safe with your breast implants.
