Patient information regarding the Allergan BIOCELL textured breast implant and expander recall

The U.S. Food & Drug Administration (FDA) has issued a notice instructing the manufacturer Allergan™ to recall its Allergan BIOCELL® textured implants and tissue expanders. University of Iowa Hospitals & Clinics will mail letters the week of Aug. 5, 2019, to all of its patients who have received breast implants or tissue expanders at its institution since 2006. The letters will let them know whether they have this type of product. We’re also reaching out to all physicians who have referred their patients to University Hospitals & Clinics for breast implant surgery to inform them of the issue.

We have not used Allergan textured breast implants for at least the past six months at UI Hospitals & Clinics and, as of now, have seen no indication of breast implant-associated anaplastic large cell lymphoma in our patients.

Because instances of the disease caused by the Allergan BIOCELL textured implants or expanders are rare, the FDA has classified the risk as low and does not recommend the prophylactic removal of the implants unless concerning signs or symptoms are identified. We are following this recommendation and are not encouraging removal of the implants unless a problem is identified.

Over 95% of patients with BIA-ALCL who present with local symptoms do so an average of approximately nine years after implant placement. The most common presenting symptom is local swelling due to a seroma – or fluid buildup – which is seen in 86% of patients. Patients less commonly present with a palpable mass or changes in the skin overlying the breast implant.

Tests such as an ultrasound or MRI are often ordered to evaluate any concerning signs or symptoms, and any suspicious fluid collections or masses identified on these tests might be aspirated or biopsied and tested for signs of BIA-ALCL. However, women who develop BIA-ALCL can often be cured by simply having the implant and any surrounding scar tissue removed.

This recall applies only to Allergan textured breast implants and expanders; it does not apply to smooth surface breast implants or expanders.

Any patient with concerns about the Allergan textured products should contact her surgeon. Patients can also call UI Hospitals & Clinics at 1-800-654-5672.

Questions and Answers

Questions and answers regarding Allergan BIOCELL textured breast implant and expander recall:

What implants/tissue expanders are being recalled?
All Allergan™ BIOCELL® textured breast implants and tissue expanders. 

Why are they being recalled?
The FDA has determined that the Allergan BIOCELL textured implants/tissue expanders have an increased risk of causing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare and treatable cancer. 

What are the symptoms?
Over 95% of patients with BIA-ALCL present with local symptoms, an average of approximately nine years after implant placement. The most common symptom is local swelling due to a seroma, or fluid buildup, which is seen in 86% of patients. Other less frequent symptoms include a palpable mass or changes in the skin overlying the breast implant. If a patient experiences these symptoms now, she should contact her surgeon as soon as possible.

Have any UI Hospitals & Clinics patients been diagnosed with BIA-ALCL because of the Allergan textured implants/expanders?
As of now, there is no record of any UIHC patients with the textured implants or expanders developing BIA-ALCL.  

How does a patient know if she has the recalled implants/tissue expanders?
Any patient who received a breast implant/expander at UI Hospitals & Clinic since 2006 will receive a letter with more information, including what type of implant was used. Letters will be sent the week of Aug. 5.

What is the risk of getting BIA-ALCL?
According to the FDA, 573 cases of BIA-ALCL have been reported worldwide. There have been 288 cases reported in the U.S., according to the Plastic Surgery Foundation’s PROFILE database which specifically tracks cases of BIA-ALCL. All cases in the U.S. PROFILE database have been associated with textured implants.

Because BIA-ALCL is a rare disease, the FDA has characterized the risk associated with the Allergan BIOCELL implants/tissue expander as “low” and does not recommend removal unless there are symptoms. Over 95% of patients with BIA-ALCL present with local symptoms, an average of approximately nine years after implant placement. The most common symptom is local swelling due to fluid collection, which is seen in 86% of patients. Other symptoms include a palpable mass or changes in the skin overlying the breast implant. 

If symptoms develop, patients should contact their surgeon right away for further evaluation.

If there are no symptoms, the patient should continue to monitor her breast area as part of a good personal health care routine and follow any other advice previously given by her surgeon.

Have there been any reported cases of BIA-ALCL related to the Allergan BIOCELL textured tissue expanders?
There have been no reported cases of BIA-ALCL associated with the temporary BIOCELL expanders. Tissue expanders are typically used for a short time to expand the breast tissue in preparation for the implant. They are removed when the implants are put into place. 
 

Additional Contact Information

UI Hospitals & Clinics: 1-800-654-5672

Allergan:  1-800-678-1605www.allergan.com

FDA information: Allergan BIOCELL textured implant and tissue expander recall