Background:

The World Consensus Conferences on Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), held in 2019, 2020 and 2021, aimed to raise awareness of this cancer. The Scientific Committee on Health, Emerging and Environmental Risks (SCHEER) of the European Commission on 2021 issued a final opinion claiming a causal relationship between all textured breast implantsand BIA-ALCL, with a moderate weight of evidence, and higher risk in individuals with intermediate-to-high surface roughness implants (according to ISO-14607:2018). Several surgical risks have been referred to BIs surgery, with mortality being the most relevant. So far, the latter has been calculated only generically for aesthetic surgery or for cosmetic breast surgery procedures, but not specifically for BI surgeries. Because of poor knowledge of risks and benefits, the prophylactic explantation of BI at high-risk for BIA-ALCL have not yet been clearly determined, leaving the decision in the hands of plastic surgeons during patients’ consultation. The understanding of specific Breast Implant Surgery Mortality rate, combined with other indicators, may assist patients and surgeons in the decision-making process, clarifying the impact of an additional BI procedure on a population already exposed to several procedures during their life for less important indications, such as implant rupture or displacement, capsule contracture etc.

Aim:

1. Assess Perioperative Mortality in Patients who Underwent Aesthetic or Reconstructive Breast Implant surgery  

2. Determine Mean Age of First Breast Implant Placement, Breast Implant Lifespan, and Overall Women Life Expectancy 

3. Determine BIA-ALCL Prevalence and Death Incidence 

Among BIA-ALCL Cases

Material and Methods:

Establish Breast Implant Surgery Mortality (BISM)

Time frame 8 years (2012-2019)

Retrospective Observational Cohort Study

BISM Was Calculated As The Rate Of Perioperative Mortality Among 

99,690 Patients Who Underwent Breast Implant Surgery For Oncologic (57369) And Non-oncologic (42321) Indication 

Review Of Literature For Breast Implant Epidemiology

Systematic Literature Review of Pubmed, Embase, Web of Science and Scopus

54 (out of 1277) Manuscripts Presented Epidemiologic Data 

BIA-ALCL Occurrence Risk and Mortality

1148 BIA-ALCL Cases and 35 Deaths

Results:

Breast Implant Related Surgery Mortality Over An 8 Years Time Frame Was 

0 : 99690

Mean Age of 1st Breast Implant Positioning is 40 years

Implant Life Span is 9.34 years

Mean Women Life Expectancy is 85.4 years

Deaths To BIA-ALCL Cases Ratio

35 : 1148

Conclusion:

Prophylactic Procedures Are Not Advocated By The FDA Or  

 National Regulatory Authorities, Not Because BI Are Considered

 Safe, But Because Of Lack Of Evidence Demonstrating That

 Explant Risk Is Inferior To BIA-ALC Risk, And That The Explant

 Might Mitigate The Occurrence.  

 Our Study Is The First To Demonstrate That 

 Breast Implant Surgery Mortality Risk Is ZERO

 Patients With Breast Implants Undergo One/More 

 Revisional Surgeries (5)During Their Lifetime

 

 A Prophylactic Indication Cannot Be Excluded On 

 The Basis Of The Potential Mortality Risk Alone

 

We Conclude That In Patients At High-risk With Textured Implants Or Pro Cancerogenic Germline Mutations It Can 

Be Reasonable To Consider A Prophylactic Explantation, 

Anticipating One Possible Future Procedure.