LegalReader.com  ·  Legal News, Analysis, & Commentary

News & Politics

FDA Issues Update on Breast Implant-related Cancer


— March 23, 2017

The U.S. Food and Drug Administration issued an update this week regarding certain types of breast implants connected to anaplastic large cell lymphoma. The condition, referred to as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare form of T-cell lymphoma.

T-cells are a type of white blood cell that forms part of the body’s immune system, according to the Lymphoma Research Foundation. Lymphoma is a type of blood cancer categorized as either Hodgkin or non-Hodgkin. BIA-ALCL is a type of non-Hodgkin lymphoma. ALCL is a rare type of cancer, accounting for roughly 12% – 15% of all non-Hodgkin lymphomas in adults.

Back in 2011, the FDA found a possible link between ALCL and breast implants. However, there were so few cases the Agency didn’t think it was possible to find the factors that were increasing the risk of developing the disease. It continued gathering data and issued a report informing healthcare professionals and the public of the facts known at that time.

According to information published by the Plastic Surgery Foundation, “Following recommendations made by the FDA in 2011, implant manufacturers added language warning of the existence of BIA-ALCL to all breast implant package inserts within the United States and Canada. The American Society of Plastic Surgeons (ASPS) includes the risk of BIA-ALCL in breast implant informed consents.”

This latest update brings the FDA’s understanding more in line with that of the World Health Organization; specifically, that there is a link between breast implants and the development of BIA-ALCL. The Agency, and most health organizations, is having difficulty determining the number of cases of BIA-ALCL. This is due to lack of world-wide reports of the disease and global implant sales data, according to a review published by the National Institutes of Health.

One thing the FDA can say, based on medical literature published since its 2011 report, is that the development of BIA-ALCL is more likely to occur in women with textured breast implants. Some of the published studies look at specific risk factors for the disease, “including the methods used to create surface texture of the implant and the role of biofilm in causing” it. The literature also shows that “women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants.”

Chart showing cross-section of female breast, identifying lymphoma
Image courtesy of www.breastimplantsgosmoothtoavoidcancer.com

Last year brought new understanding of BIA-ALCL, both in terms of the disease and treatments:

  • “The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma as a rare T-cell lymphoma that can develop following breast implants.
  • Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) published information to help physicians understand the disease and provide diagnosis and treatment.
  • Regulatory bodies outside the United States issued communications on BIA-ALCL.
    • The Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths. None of the cases occurred in women with smooth implants. TGA estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants.
    • The French National Agency for Medicines and Health Products Safety (ANSM) asked manufacturers of textured breast implants to perform biocompatibility testing (testing to determine how living tissues react to textured implants) and to report their findings within a year.”

The FDA acknowledges receipt of 359 medical device reports (MDRs) regarding BIA-ALCL as of February 1, 2017. Of these reports:

  • 231 referred to the surface of the implants
    • 203 of those involved textured implants
    • 28 involved smooth implants
  • 312 dealt with the types of filler in the implants
    • 186 were filled with silicone gel
    • 126 were filled with saline
  • 9 deaths were reported

 According to the FDA, “Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.”

Steps to Protect Your Health

If you are considering breast implants, discuss the risks and benefits of smooth- versus textured-surface implants. If you already have breast implants, the Agency advises that no change to your routine medical care and follow-up is needed. Continue your routine care, including:

  • “Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants.
  • If you have silicone gel-filled breast implants, get periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.”

Patients and healthcare professionals, please report all cases of BIA-ALCL to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. To do so, either:

  • Follow this link;
  • Download a form and mail it to the address on the form;
  • Call 1-800-332-1088 to get the form.

Forms may also be faxed to the Agency at 1-800-FDA-0178.

These reports will help the FDA and other organizations improve their understanding of BIA-ALCL.

Sources:

Breast Implants: Update – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Join the conversation!