Death by Implants

Critical Analysis of the FDA-MAUDE Database on Breast Implant-related Mortality

Jad Abi-Rafeh, HBSc, MSc; Tyler Safran, MD; Becher Al-Halabi, MD, MHPE; Tassos Dionisopolous, MD, FACS, FRCSC

Disclosures

Plast Reconstr Surg Glob Open. 2019;7(12):e2554 

In This Article

Abstract and Introduction

Abstract

Introduction: Since the 1992 moratorium by the Food and Drug Administration (FDA), the debate on the association of breast implants with systemic illnesses has been ongoing. Breast implant-associated anaplastic large cell lymphoma has also raised significant safety concerns in recent years.

Methods: A systematic search of the Manufacturer and User Facility Device Experience (MAUDE) database was performed to identify all cases of breast implant-associated deaths reported to the FDA.

Results: The search identified 50 reported cases of apparent implant-related mortality; breast implant-associated anaplastic large cell lymphoma comprised the majority of fatal outcomes (n = 21, 42%), followed by lymphoma (n = 4, 8%), breast cancer (n = 3, 6%), pancreatic cancer (n = 2, 4%), implant rupture (n = 2, 4%), and postoperative infections (n = 2, 4%). Single cases (n = 1, 2% each) of leukemia, small bowel cancer, lung disease, pneumonia, autoimmune and joint disease, amyotrophic lateral sclerosis, liver failure, and sudden death, and 2 cases (4%) of newborn deaths, to mothers with breast implants, were also identified. A literature review demonstrated that 54% of alleged implant-related deaths were not truly associated with breast implant use: the majority of these reports (82%) originated from the public and third-party sources, rather than evidence-based reports by health-care professionals and journal articles.

Conclusions: Although there exists a need for more comprehensive reporting in federal databases, the information available should be considered for a more complete understanding of implant-associated adverse outcomes. With only 46% of FDA-reported implant-related deaths demonstrated to be truly associated with breast implant use, there exists a need for public awareness and education on breast implant safety.

Introduction

Breast implants represent a multi-million dollar industry and a large proportion of aesthetic procedures presently performed by plastic surgeons worldwide.[1] It is estimated that, each year, at least 1.5 million implants are used for aesthetic and reconstructive purposes.[2] Modern-day implants are a product of constant evolution from the first generation developed by Dow Corning (Midland, Michigan, USA) in 1963, a process veiled with both controversy and safety concerns.[1,3]

In 1992, the Food and Drug Administration (FDA) issued a moratorium on silicone gel-based breast implants in response to culminating, well-publicized anecdotal reports linking implants to systemic diseases.[4,5] Billions of dollars would be issued in lawsuit settlements in the coming years, fueled by public concerns that would continue to grow, and reinforced by the very issuing of the moratorium itself.[5] This prompted scrutiny of the available evidence, refuting any association between breast implants and cancer, systemic diseases, immune dysregulation, connective tissue disorders, or other neurological dyscrasias.[5–7] The moratorium lifting in 2006, conditional on large and longitudinal market studies by major producers, represented collaborative efforts between the FDA, industry, and medical professionals to respond to fathomable public concern in an evidence-based fashion.[3,6,8]

Several years later, however, in 2011, and in response to 34 reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), the FDA released a new safety communication.[9,10] BIA-ALCL, a unique type of non-Hodgkin T-cell lymphoma, is associated with textured implants and commonly presents as a late peri-implant seroma, swelling, and tenderness of the affected breast.[10–12] An update to the original safety communication regarding BIA-ALCL was issued by the FDA in 2016, reporting that a total of 258 cases had been submitted to their Manufacturer and User Facility Device Experience (MAUDE) database until that date.[10] In 2019, a further update was issued reporting that, since 2010, the agency had received medical device reports on a total of 457 new cases, including 9 deaths.[13] This reinstated concerns among the public and prompted further research to better understand the epidemiology and pathophysiology of BIA-ALCL, especially with regard to the safety of textured implants.[2,10,14,15]

The FDA requires all manufacturers to report on malfunctions or device-related adverse events to its MAUDE database; patients and health-care professionals may also author their own entries.[2] This database thus represents a valuable resource for patients, consumers, and health-care professionals on medical device-related adverse outcomes.[2,16] The primary aim of this study was to conduct a systematic search of the MAUDE database for all implant-related deaths reported to the FDA and assess the proportion attributable to adverse outcomes truly linked to breast implant use, as presently established in the literature.

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