News

Researchers estimate risk of death from BIA-ALCL


 

and Drug Administration

Breast implant Photo from US Food

The risk of death from breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is less than 1 in a million, according to a study published in Aesthetic Surgery Journal.

Researchers analyzed data on breast implants and estimated the risk of death from BIA-ALCL to be 0.4 micromorts for a woman with bilateral, textured implants.

One micromort means a person’s risk of dying is 1 in a million. For context, a person who drives a car for 1 hour per day is said to have a micromort of 2, which is 5 times the BIA-ALCL micromort.

The researchers noted that there are no documented cases of BIA-ALCL in patients who have only received smooth-surface breast implants. Therefore, the risk of death from BIA-ALCL in a woman with smooth breast implants is “essentially 0.”

“We conducted this micromort study to bring real-life perspective for all existing and potential breast augmentation patients who might have reservations about implants based on the recent media coverage indicating that breast implants can be fatal—a sensationalized take on a very rare and very treatable condition,” said study author William P. Adams, Jr, MD, a professor in the Department of Plastic Surgery at the University of Texas Southwestern in Dallas.

“This analysis resonates with patients. They get it when you explain to a patient that their micromort risk from skiing for 1 day is 2 times higher than the micromort risk of having a textured breast implant for their lifetime—or that traveling 8 hours by car carries a 40-times higher micromort risk than having 2 textured breast implants for their lifetime.”

Dr Adams and his co-author analyzed data from the International Society of Aesthetic Plastic Surgery, the American Society of Plastic Surgeons, the American Society for Aesthetic Plastic Surgery, and the Austrian Breast Implant Register, as well as studies by Allergan and Sientra.

This led to a “conservative estimate” that approximately 30 million patients have textured breast implants worldwide (not including breast reconstructions).

This figure and the report of 12 deaths from BIA-ALCL worldwide suggest the risk of death from BIA-ALCL is 0.4 micromorts per patient (with 2 textured implants) or 0.2 micromorts per textured implant.

“The findings of this study are very important for patient education,” said study author David A. Sieber, MD, a plastic surgeon in private practice in San Francisco, California.

“The clear lymphoproliferative nature of BIA-ALCL, along with the calculated risks associated with its diagnosis, should be used for discussion during new consultations or at the time of presentation for evaluation of delayed-onset seromas.”

Recommended Reading

Lenalidomide maintenance boosts survival in de novo myeloma after ASCT
MDedge Hematology and Oncology
Crizotinib shows responses in pediatric ALCL and IMT
MDedge Hematology and Oncology
Vitamin D level linked to post-alloSCT relapse risk in myeloma
MDedge Hematology and Oncology
Obinutuzumab-CHOP not superior to rituximab-CHOP in new DLBCL
MDedge Hematology and Oncology
High healthcare costs follow CCSs into adulthood
MDedge Hematology and Oncology
Drug granted orphan designation for chemo-induced ototoxicity
MDedge Hematology and Oncology
Antibody could treat AML, MM, and NHL
MDedge Hematology and Oncology
Drug granted priority review for CTCL
MDedge Hematology and Oncology
Post-approval trials for accelerated drugs fall short
MDedge Hematology and Oncology
New cancer diagnosis linked to arterial thromboembolism
MDedge Hematology and Oncology