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Information on Breast Implants and ALCL(Anaplastic Large Cell Lymphoma)  


FROM THE FDA Website

"As of July 6, 2019, the Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all MDRs the FDA received with any mention of "ALCL" or other spelling variations (for example, "anaplastic lymphoma," or "anaplastic") in the event narrative. BIA-ALCL MDRs are counted for those reporting a diagnosis or treatment of ALCL, or confirmed pathology/cytology test, or Anaplastic Lymphoma Kinase (ALK) and CD30 biomarkers.

  • There is a risk of developing a type of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the breast or scar tissue (capsule) surrounding the implant. BIA-ALCL is not breast cancer. Treatment of BIA-ALCL involves removal of the implant and the capsule surrounding the implant and some patients have required chemotherapy and/or radiation therapy. 
  • Although treatable, there is a risk of death for patients diagnosed with BIA-ALCL.
  • Some breast implant patients report a variety of systemic symptoms, such as chronic fatigue, brain fog, joint and muscle pain, which may not meet the diagnostic criteria to be categorized as a disease. Patients refer to these symptoms collectively as “breast implant illness (BII).”  In some cases, patients report that removal of their breast implants without replacement appears to reverse their symptoms."

 

- From FDA information on Breast Implant and ALCL

FDA RECALL from FDA Website

"The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system. Based on the currently available information, the FDA's analysis demonstrated that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan's BIOCELL textured breast implants would likely cause serious, adverse health consequences, including death, from BIA-ALCL.

Of the 573 worldwide reported total cases of BIA-ALCL, 481 patients are reported to have Allergan breast implants at the time of diagnosis. Of those cases, 12 deaths occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis.

Although Allergan Natrelle 133 and 133 Plus tissue expanders have not been associated with BIA-ALCL to date, both devices have the same Biocell texture. While tissue expanders are only indicated to be used for 6 months, to date there is no information on what duration of exposure to the Biocell texture may induce BIA-ALCL."

 - From FDA Website Regarding Recall

 


For more information Please click on one of the links below: 


FDA information on Breast Implant and ALCL immune cancer

American Society of Plastic Surgeons

National Institute of Health