Textured Breast Implants Reported in All Confirmed Cases of BIA-ALCL

Published on August 19, 2019 by Sandy Liebhard

A new study is providing some of strongest evidence to date of a link between textured breast implants and a rare form of non-Hodgkin’s lymphoma.

The research, which was published earlier this month in  the Journal of Surgical Oncology, found that every confirmed case of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has occurred in women who had received textured devices.

Nearly 400 Scientific Papers on BIA-ALCL Reviewed

The authors of the study conducted a literature review of 391 scientific papers on BIA-ALCL, including 85 case reports.  Patients were an average of 53.6 years old and had textured breast implants for an average of 9.9 years before their cancer diagnosis. The most commonly reported symptoms included breast swelling, tenderness, skin problems, fevers, chills, weight loss, and night sweats.

“There is no consensus on the pathogenesis of BIA-ALCL, although many theories have been proposed. Chronic but mild stimulation of the immune system due to the implant or bacteria around the implant are the most commonly proposed etiologies,” the researchers wrote. “Allergic reaction to the implant has also been proposed as a possible etiology due to the presence of interleukin-13, a cytokine associated with allergic inflammation.”

The U.S. Food & Drug Administration (FDA) first warned of BIA-ALCL in 2011.  Though some medical device reports logged with the agency indicated victims had received smooth-surfaced breast implants, the authors of this study were unable to confirm any of those reports.

BIA-ALCL And Allergan Biocell Textured Breast Implants

Last month, the FDA warned that 573 women had developed BIA-ALCL, including 31 who died as a result of the rare lymphoma. The agency also asked Allergan, Inc. to recall Biocell textured breast implants, after those devices were cited in 80% of cases and at least 12 of the fatalities.

Allergan complied, and announced a worldwide breast implant recall for the following products:

• Natrelle Saline breast implant styles 168, 363, 468
• Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
• Natrelle and McGhan 410 Soft Touchbreast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
• Natrelle 510 Dual-Gel styles LX, MX, FX
• Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
• Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
• Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
• Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
• Natrelle 150 Full Height and Short Height double lumen implants
• Natrelle 133 tissue expanders with and without suture tabs:  styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
• Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX,
  133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T

However, textured breast implants manufactured by Mentor and Sientra remain available in the United States, and there are currently no plans to recall those devices.

What You Should Know about Breast Implant Lymphoma

BIA-ALCL is usually treatable if detected early. When the cancer has proven fatal, diagnosis was delayed an average of two years after symptoms first appeared.

Treatment for BIA-ALCL generally includes removal of the breast implants, as well as any cancerous masses. However, additional intervention may be needed if the cancer spreads beyond the breast implant scar capsule.

The FDA has not recommended that women with Biocell breast implants have the devices removed if they are not experiencing symptoms. However, they should become familiar with the symptoms of BIA-ALCL, especially persistent swelling or pain in the vicinity of the breast implant, and report any changes to their doctor immediately.