Why the Recall for Allergan Textured Implants?
There has been recurrent media coverage over the past year about a rare subtype of lymphoma that has been diagnosed in a small but increasingly reported number of women who have textured implants. It is called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). From the FDA website:
BIA-ALCL is not breast cancer – it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy. FDA.gov
The FDA Hearings
On March 25 and 26, 2019, the FDA conducted a public advisory committee meeting to study the associated risks of implants used for both augmentation and breast reconstruction. The focus of the hearing and public statements from industry, medical professionals, and patient advocates was to discuss the concerns of BIA-ALCL related to the textured implants.
Data Gathered on BIA-ALCL
The American Society of Plastic Surgeons (ASPS) has a comprehensive collection of evidence-based articles on the topic of BIA-ALCL. I have attended Plastic Surgery the Meeting (PSTM) for the past three years as a patient advocate. There were sessions I attended and spoke to the physicians who presented information on detection, treatment, and data gathered on BIA-ALCL. There are more sessions scheduled for the meeting this September in San Diego. I plan attending those sessions as well to stay updated on the work ASPS is doing. Ongoing collection and increased evidence of patient data confirming the incidence of BIA-ALCL across the globe prompted the recall.
What Should You Do if you Have Implants?
These are the clinical steps I would follow if I had implants of any kind after hearing about the Allergan textured implant recall.
- Check the Allergan or FDA websites for a list of products that have been recalled.
- If you do not know what type of implant was used for your reconstruction, call the office of your plastic surgeon to find out exactly what type it is for your peace of mind and records.
- Keep a record of this information. Ask if there is a card from the implant manufacturer you can keep with you at all times or in your medical records to monitor any future recalls. I have spoken to patients who are “card carrying members” from the manufacturer for the implant used in their reconstructive surgery.
- Breast cancer patients generally have a heightened sense of their health and symptoms they experience after treatment and surgery. At this time the FDA does not recommend removal of these or other types of implants in patients who have no symptoms because of the low risk of BIA-ALCL. Report any changes to a board-certified plastic surgeon if you had implants placed and are experiencing any of the following symptoms as seen on the ASPS website for BIA-ALCL resources:
The majority of patients present as a delayed seroma, but also present with symptoms of mass, skin rash, fever and night sweats, and lymphadenopathy. Diagnosis is based on ultrasound?guided fine needle aspiration of the peri-implant fluid, which is assessed with immunohistochemistry for CD 30-positive large anaplastic T-cell lymphocytes.
Final Thoughts on the Allergan Textured Implant Recall
Breast Reconstruction is a difficult choice for anyone to make requiring a great deal of research. It is a personal choice. Whether you choose to use your own tissue or implants to reconstruct your breasts when affected by breast cancer, be informed. Do your homework to find a board-certified plastic surgeon. Your surgeon will hand you an informed consent about the possible risks and complications of your reconstructive surgery. These informed consents are included in plastic surgery consults. This informed consent includes the risks of BIA-ALCL if you are choosing implants.
Many plastic surgeons I know have not been using textured implants for some time. I also know there are plastic surgeons who are explanting (removing) implants for a number of reasons not associated with BIA-ALCL. This involves more surgery, more risks, and possible complications. Be informed. My hope is, always, the decisions you make is based on a shared decision-making conversation with your health care team.
Wonderful perspective and information! Thank you!
Thank you very much for you comments, Dalynn. Great hearing from you. ~ Terri