David A. Lickstein, MD FACS
Board Certified Plastic Surgeon
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David A. Lickstein, MD FACS
Breast Implant Safety
A New York Times article this week regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL) has concerned many patients and led to a lot of phone calls and questions. The article referred to an update issued in March of this year by the FDA.
A New York Times article this week regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL) has concerned many patients and led to a lot of phone calls and questions. The article referred to an update issued in March of this year by the FDA.
While this recent report caught the attention of the media, this is not a new entity, and the FDA issued the first report of a possible association in 2011. To be clear, this is not breast cancer. Although classified as a lymphoma, current research suggests that BIA-ALCL may be eventually be reclassified as a lymphoproliferative disorder. The World Health Organization recognized the condition as an entity in 2016, and treatment guidelines were standardized by the NCCN (national comprehensive cancer network) for the first time this year.
To date, the condition is extremely rare. It is estimated that between 10 and 15 million women worldwide have breast implants. 359 cases have been reported. 9 deaths have occurred. It is not certain if the data is completely accurate for these cases as the reporting methodology has significant limitations. Early reports of deaths attributed to the condition may have been affected by difficulty making the correct diagnosis. 232 reports contained information about the type of implant used. What is new information is that the latest FDA report implicated the textured surface of implants. There were no cases reported with exposure to only a smooth device. The fill of the implant, silicone or saline, had no impact on the development of the condition.
Your practitioners should now be aware of the condition, and understand the symptoms, diagnosis, and recommended treatment. Discussion of the condition should be included in the informed consent process for surgery for any patient considering placement of implants for cosmetic or reconstructive reasons. It is also worth noting that many of the tissue expanders used in breast reconstruction have textured surfaces.
The condition presents as swelling of the breast, between 2-10 years after insertion of the implant. Patients with suspected cases of BIA-ALCL should have fluid sampled from the area around the implant and tested for the CD-30 marker. Patients diagnosed promptly, without evidence of lymph node involvement have been cured by removal of the implants and surrounding capsule.
The proposed mechanism at present involves interplay between the surface of the implant, the immune response of the patient, possible bacterial coating of the implant, and potential genetic predisposition to the condition. Studies in a series of cases have demonstrated a thin coating on the implants, also known as biofilm, with a rare bacteria. Textured implants have a greater surface area, and more potential for bacteria to adhere to the surface of the implant. Plastic surgeons have known for some time that biofilm may cause a chronic inflammatory response, and contribute to capsular thickening or contracture. It is quite possible that in certain predisposed patients, or with certain types of bacteria, the chronic inflammation progresses past capsular tightening to BIA-ALCL.
The FDA has not recommended implant exchange or removal for patients with textured implants who are free of symptoms, as this remains a very rare condition.
If you currently have implants:
- Follow up with your plastic surgeon yearly. They will advise you regarding recommended imaging studies and any new information available.
- Pay attention to any changes in your breasts, and seek evaluation if the breast becomes swollen
- Make sure you are aware of the type of implant you have
- Communicate any concerns with your plastic surgeon, and treatment team
The most current information is available on websites for the FDA, American Society of Plastic Surgeons, and the American Society for Aesthetic Plastic Surgery.
