Dear Valued Patients,
Following the recent recall of textured breast implants, we are reaching out to our database in order to assist our patients in understanding the details surrounding the recall. Please read the following information, and feel free to reach out to us with any questions or concerns.
Allergan, one of the leading manufacturers of breast implants, was asked by the FDA to voluntarily recall their BIOCELL Textured Breast Implants. The recall includes the Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction.
What is BIA-ALCL?
BIA-ALCL stands for Breast Implant Associated Anaplastic Large Cell Lymphoma. This is an uncommon and highly-treatable type of lymphoma that can develop around Textured implants:
○ In most cases presented 8-9 years after surgery, though as early as 2 years and as late as 28 years in other cases.
○ In both saline & silicone Textured Implants
○ NO cases have been reported with Smooth Implant
What are the symptoms?
Initial symptoms of BIA-ALCL include swelling or significant enlargement of the breasts over a period of days or weeks. It can also present as a lump in the breast or armpit, firmness of the breast, or pain. If you have any of these symptoms, please call our office to schedule a consultation with Dr. Leverett.
The FDA does not recommend or suggest that patients without symptoms remove their implants, however if you have concerns, please call our office to schedule a consultation. Options include removal of the breast implants, or exchanging from textured to smooth implants.
What is the treatment plan?
First, call our office to schedule a consultation & evaluation with Dr. Leverett.
After the exam, an Ultrasound or MRI may be ordered if needed.
Dr. Leverett will perform the explantation surgery with an “En Bloc” total capsulectomy. This removes the entire capsule surrounding the implant in one piece.
The implants can either be removed, or exchanged for Smooth implants.
For patients with confirmed Allergan textured implants that choose to replace their BIOCELL textured implants with smooth implants due to the recall, Allergan will provide Allercan smooth device replacements for free. The program will run for 24 months, until July 24th 2021 and will apply to revision surgeries on or after the date of the recall announcement, July 24, 2019.
What is the risk of developing BIA-ALCL?
The FDA reports that it is 1:3,817 to 1:30,000 in their latest statement. These risk assessments are changing on an ongoing basis, but this is the most accurate information currently available.
How do I know what kind of implants I have?
After your surgery, you were given an implant ID Card – this will contain the details of the manufacturer and type of your implants. Please call us if you are unclear with how the card is labeled. If you do not have this card and you were a breast implant patient of Dr. Leverett or Dr. Pavese, please contact us so we can pull your medical records. For legal reasons, medical records older than 7 years may have been destroyed, but we will do everything we can to help you determine your implant type.
We hope this email has been helpful in providing you with information regarding this recall. We are here as your resource for any breast surgery or implant questions, please do not hesitate in reaching out to us for assistance.