Because of the elevated risk of patients developing anaplastic large cell lymphoma (BIA-ALCL) from Allergan BIOCELL textured breast implants, the government has asked the manufacturer to voluntarily recall the affected tissue expanders and breast implants. Allergan has agreed to comply with the Food and Drug Administration’s (FDA) request and is taking the products off the global market.
Recall Prompted by Medical Reports
Recent Medical Device Reports (MDRs) from around the world report BIA-ALCL cases and even deaths related to BIOCELL textured breast implants and tissue expanders. Based on these medical reports, the FDA issued a request for Allergan to recall the devices, and Allergan notified the government agency that it will act in accordance. All of the included products have the same “shell,” a BIOCELL textured surface that is unique to this manufacturer.
Connection to BIA-ALCL Cases
Worldwide, there has been a reported total of 573 cases of BIA-ALCL, including 33 deaths. Over 80 percent of the 573 individuals had Allergan breast implants when they received the diagnosis. Thirteen of the deaths occurred in patients for whom the breast implant manufacturer was known. Of these 13 individuals, 12 of them had an Allergan implant when diagnosed with BIA-ALCL. Of the remaining 20 deaths, the texture and/or manufacturer is not known.
Newly submitted data, available information, and current analysis seems to indicate that the risk of acquiring BIA-ALCL is six times greater with Allergan BIOCELL textured implants than with any of the other textured implants manufactured for marketing in the U.S. Based upon such information, it is understandable why the FDA would determine that further distribution of Allergan’s specified products could likely cause severe adverse health issues and possibly death.
After further evaluation, the FDA may take action in regard to other breast implants, if warranted. Most cases of BIA-ALCL have been connected with the use of macro-textured implants like Allergan’s. The agency is continuing its assessment to find out if the risk of developing the disease is connected only to specific models of textured implants or, perhaps, to all textured breast implants. In light of this ongoing research, the FDA believes that anyone who is thinking of getting any type of breast implant should be informed of the heightened risk of acquiring BIA-ALCL.
What is BIA-ALCL?
It’s not breast cancer. Rather, it’s a cancer of the immune system, a type of non-Hodgkin’s lymphoma. BIA-ALCL is being found, in most cases, in the fluid and scar tissue near the breast implant. However, it’s possible for the disease to spread through the body.
At present, the overall risk of acquiring this cancer is thought to be relatively low. The disease is very serious, though, and could potentially lead to death, particularly if it’s not detected early or treated promptly. Most patients are successfully treated through surgical removal of the implant and the surrounding scar tissue. Some patients, however, may need radiation and/or chemotherapy treatment.
Recommendations for Patients with the Device Implanted
- If no symptoms are present, the FDA is not suggesting these or any other types of breast implants should be removed because the overall risk of BIA-ALCL is low. All questions, though, should be discussed with a health care provider.
- Learn the symptoms. BIA-ALCL will primarily produce persistent pain or swelling at or near the site of the breast implant. Therefore, a patient should regularly monitor the area of the breast implant for changes.
- Should any changes or above-mentioned symptoms occur, an individual is advised to speak with a health care provider to arrange further evaluation if needed. Such an evaluation would likely include a physical exam, assessment of the surrounding tissue or fluid, and/or imaging. Such an evaluation to diagnose the disease is important, because a confirmed case of BIA-ALCL could alter the type of operation to be performed.
- After consultation with a medical provider, individuals with confirmed cases of BIA-ALCL should have the breast implant removed, along with the scar capsule surrounding the implant. This dual removal requires a more extensive surgery than just the implant alone.
- Any patient with an implanted device should record and keep specifics like the model name, device manufacturer, and the unique device identifier. This information is frequently provided on a patient card at the time of surgery. However, the information should be obtainable after-the-fact by contacting the surgeon or requesting surgery records from the facility where the operation took place.
- Keep in mind that BIA-ALCL tends to occur years after a breast implant was surgically placed. For answers to questions, speak with the surgeon about the potential risk of BIA-ALCL.
Recommendations for Medical Providers
- Do not use (implant) Allergan BIOCELL breast implants any longer. Any existing inventory should be returned.
- Presently, the FDA is not recommending the removal of breast implants in individuals who show no symptoms, because the overall risk of developing BIA-ALCL is low.
- Tell patients about BIA-ALCL risks and symptoms.
- Before any surgical implantation of breast implants, give patients educational material, consult about the risks and benefits of various implants, and provide the manufacturer’s patient labeling.
- Because some individuals developed a mass, seroma, or hardening near the breast implant, consider BIA-ALCL if patients appear to have peri-implant changes that are late onset. If a patient is suspected of having BIA-ALCL, let knowledgeable experts who are familiar with the disease conduct an evaluation.
- Collect representative parts of the capsule and fresh seroma fluid to send for pathology tests. Evaluation needs to include cytological evaluation of the seroma fluid or mass with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation (CD30) and Anaplastic Lymphoma Kinase (ALK) markers.
- When choosing the approach for treatment, consider using recent clinical practice guidelines like the ones from the Plastic Surgery Foundation of the NCCN (National Comprehensive Cancer Network.)
- Report all cases of patients with breast implants who develop BIA-ALCL to the FDA’s adverse event reporting program called MedWatch.
- In facilities where the FDA’s reporting requirements demand it, health care personnel working in such facilities need to follow the established reporting procedures there. Quick reporting of adverse health events can assist the agency in identifying risks connected to medical devices. The FDA may need to contact the reporting individual for further information. Identities of the patient and the person reporting are kept confidential.
- To help provide a better understanding of BIA-ALCL causes and treatment, reports of all cases should be submitted to the PROFILE Registry (Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma etiology and Epidemiology.)
For Breast Implant Patients
Action by the FDA in requesting a voluntary recall may produce concern on the part of individuals with breast implants, particularly if their device is mentioned by name. The agency will continue to monitor the situation and evaluate adverse event reports in databases. The FDA notes that only about 10 percent of the breast implant devices sold in this country are textured implants.
The recommendations listed above should help patients and medical providers more fully understand the risk of developing BIA-ALCL. Further educational information about the disease can be found on the FDA’s site. The agency will continue updating the public as developments arise.
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- U.S. Food and Drug Administration. “The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication”, FDA. Accessed August 9, 2019.