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Dear ASPS member:
On July 24, Allergan issued a voluntary worldwide recall of its BIOCELL textured breast implants and tissue expanders based on an FDA analysis that found an increased risk of developing BIA-ALCL in patients with Allergan BIOCELL textured implants than in those with other types of textured implants.
Recognizing that patients with these implants will likely have questions about their risk of developing BIA-ALCL and what, if any, action to take, ASPS provides a wealth of updated resources for both patients and physicians on its website at PlasticSurgery.org/ALCL.
These resources include a sample patient-letter template (login required), which can be customized by ASPS members to contact their patients with information about the device recall or BIA-ALCL in general.
Additional resources include:
- BIA-ALCL Summary and Quick Facts
- BIA-ALCL By the Numbers/Statistics
- FDA Recommendations for Those Considering Breast Implants
- Educational Brochure for Patients
- Collection of PRS Papers on BIA-ALCL
- PRS supplement on BIA-ALCL (March 2019)
- Informed Consent Language
- Information on the Textured BIOCELL Recall
- Sample Letter to Patients (login required)
- Additional Resources
ASPS is encouraging any concerned patients to contact their board-certified plastic surgeon. It’s important to note that the only implants affected by the recent recall are Allergan’s BIOCELL textured implants and tissue expanders, which account for roughly 5 percent of all breast implants in the United States. Based on current confirmed cases and textured implant sales data over the past two decades, the risk of a woman with textured breast implants developing BIA-ALCL ranges from 1:2207 to 1:86,029.
Due to the low risk of developing BIA-ALCL, the FDA does NOT recommend that patients seek to have their implants removed unless they experience symptoms, which may include: fluid collection/seroma, pain, lump in the breast or lymph node in the armpit, swelling, rash, fever, weight-loss or unexpected changes in breast shape, including asymmetry. Seventy (70) percent of BIA-ALCL cases present with a seroma.
ASPS has been actively investigating BIA-ALCL for nearly a decade and, in 2012, The Plastic Surgery Foundation (PSF) created PROFILE (Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma, Etiology and Epidemiology) in collaboration with the FDA to better understand the role of breast implants in the etiology of BIA-ALCL.
As of Aug. 2, there are 288 BIA-ALCL cases registered in PROFILE from the United States and Canada. The FDA reports 573 U.S. and global medical device reports (MDRs) of BIA-ALCL in its MAUDE database (the FDA acknowledges that the MAUDE database may contain limited and potentially inaccurate adverse event reports, and may not represent the true number of U.S. cases, as some entries are duplicates and not all cases are confirmed as BIA-ALCL).
Worldwide, ASPS recognizes 735 confirmed cases of BIA-ALCL, including 21 deaths.
Any suspected or confirmed cases of BIA‐ALCL should be reported for inclusion in the PROFILE registry at ThePSF.org/PROFILE and to the FDA.
All ASPS members are also encouraged to participate in the National Breast Implant Registry (NBIR) and can register at ThePSF.org/NBIR. Regularly updating the NBIR with your breast implant procedure data is essential to ensuring patient safety. We need plastic surgeons to participate in this very important initiative. To learn more or request a demo, please visit ThePSF.org/NBIR.
ASPS is currently preparing additional resources for members and your patients.
For more information, visit the ASPS website at PlasticSurgery.org/ALCL or call the Society at 847-228-9900. ASPS members contacted by the media are encouraged to forward inquiries to Adam Ross, ASPS Media Relations manager, at [email protected] or 847-228-3361.
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