Breast Implant Safety – Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

By on May 16, 2019 under Breast Augmentation, Breast Implants

Anyone who gets breast implants run the risk of getting anaplastic large cell lymphoma, a type of non-Hodgkin’s lymphoma; which is a cancer of the immune system. This disease is usually found in the fluid and scar tissue that develops around the implant, and in extreme cases, it can spread through the body.

Background

Back in 2011, The FDA was able to identify a relationship between patients that have breast implants and have experienced anaplastic large cell lymphoma or ALCL. Back then, the FDA was unable to determine specific patterns due to the small number of ALCL cases that were apparent. They were unable to characterize its exact cause.

However, as time went on, they have been able to get a stronger understand of the condition and how it works. Back in 2016, the World Health Organization was able to designate breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL as a T-cell lymphoma that was directly caused by getting breast implants. The studies on this matter show that most cases of BIA-ALCL are related to breast implants that come with a textured surface as opposed to those with smooth surfaces.

FDA Actions

The FDA is constantly evaluating and collecting information on individuals that have breast implants and have ALCL. According to our research, the following are some of the ways they keep track of things:

  • Monitoring adverse events from data in the real-world
  • Review and receive MDRs or medical device reports
  • Review information that is provided from post market studies that are on-going
  • Review current medical literature
  • Review data from the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology

Current Status

Since 2016, treatments and a description of this disease have had several advances, which can be summarized as:

  • The National Comprehensive Cancer Network and the Plastic Surgery Foundation are two of the professional organizations that have published information to help with both treatment and diagnosis of the disease.
  • The World Health Organization has found and recognized that BIA-ALCL is a unique form of ALCL that can develop after having a breast implant.

Medical Device Reports

As of 2018, FDA has found over 660 total cases of BIA-ALCL, and 9 cases, which resulted in the death of the patient. MDR reports do not show a history of a patient’s breast implant surgeries, so, it is not apparent if those that have a single implant or multiple implants are more likely to get BIA-ALCL.

However, the MDR system has proven to be a valuable source of information, but it does depend highly on accurate reporting, which can be skewed by human error at times. There also runs a risk of unreported cases that do not meet the MDR reports, which have to be considered.

Recommendations

Health Care Providers:

Any patient that has had breast implants should be monitored closely to make sure that they do not show signs of BIA-ALCL. It has been identified that it is more prominent in those that have revision operations and persistent seroma. The current recommendations for health care professionals according to the Plastic Surgery Foundation and the NCCN include:

  • When testing for BIA-ALCL, you should collect a free seroma fluid sample to help represent portions of the capsule and then send it to the pathology lap for testing.
  • You should develop a treatment plan that is individualized specifically for each patient to provide the best care possible.
  • You should report all cases of the disease to the PROFILE Registry to ensure that it will help researchers better understand the causes and treatments of the disease.

Patients

When you are thinking about getting beast implants, the best thing that you can do to protect yourself is research things before agreeing to the surgery. If you do have breast implants, it is important to continue with your routine medical care and follow-up sessions to catch signs, as early as possible.