US FDA Breast Implant Postapproval Studies

Long-term Outcomes in 99,993 Patients

Christopher J. Coroneos, MD, MSc; Jesse C. Selber, MD, MPH; Anaeze C. Offodile II, MD, MPH; Charles E. Butler, MD; Mark W. Clemens, MD

Disclosures

Annals of Surgery. 2019;269(1):30-36. 

In This Article

Abstract and Introduction

Abstract

Objective: To analyze the long-term safety and efficacy outcomes of patients with breast implants.

Summary Background Data: Research is ongoing regarding the safety of silicone breast implants. Despite the number of patients with breast implants followed by United States Food and Drug Administration large postapproval studies (LPAS), this database has not been thoroughly analyzed or reported.

Methods: This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from 2 manufacturers (Allergan and Mentor) placed for primary/revision augmentation/reconstruction. Systemic harms, self-harm, and reproductive outcomes are compared with normative data. Implant-related complications are analyzed by implant composition and operative indication in the short and long terms.

Results: LPAS data includes 99,993 patients, 56% of implants were silicone for primary augmentation. Long-term magnetic resonance imaging surveillance is under 5%. Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome (Standardized incidence ratio [SIR]8.14), scleroderma (SIR 7.00), rheumatoid arthritis (SIR5.96), stillbirth (SIR4.50), and melanoma (SIR3.71). One case of BI-ALCL is reported. There is no association with suicide. In the short term, rupture is higher for saline (2.5% vs. 0.5%, P < 0.001), and capsular contracture higher for silicone (5.0% vs. 2.8%, P < 0.001). At 7 years, reoperation rate is 11.7% for primary augmentation, and 25% for primary/revision reconstruction. Capsular contracture (III/IV) occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations.

Conclusions: This is the largest study of breast implant outcomes. Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.

Introduction

Responding to public opinion, the United States Food and Drug Administration (FDA) prohibited use of silicone gel-filled breast implants in 1992.[1] Concerns included incidence of cancer, connective tissue disease (CTD), and autoimmune disease. The Institute of Medicine subsequently concluded there was no evidence to support an association between breast implants and these systemic diseases.[2] Current generation silicone gel-filled implants were approved by the FDA in 2006[1] for two manufacturers: Allergan and Mentor Corp (Mentor).[3] While implant-specific local complications were adequately characterized at the time of approval, the FDA stipulated manufacturers conduct large postapproval studies (LPAS) monitoring outcomes for imaging surveillance, long-term safety and outcomes, and possible systemic harms due to silicone.

Postapproval studies include patients with silicone or saline breast implants for primary or secondary breast augmentation or reconstruction. Follow-up time horizon is 10 years. Overall, LPAS enrolled nearly 100,000 patients. Despite abundant data collection, and open public access, the LPAS database has yet to be thoroughly analyzed or reported; this manuscript represents the first report of those data. The existing literature is sponsored by industry,[4–8] and focused on a single manufacturer by design. Analyses have included follow-up from smaller FDA "Core Study" datasets,[4,5,7–9] studies primarily intended to investigate implant-specific, local complications geared toward FDA approval. These were not designed with adequate power to detect "rare" systemic harms, or with enough centers to be generalized to "real-world" effectiveness.

Breast implants are used in nearly 300,000 augmentations and 100,000 reconstructions annually in the United States,[10,11] however prospective research is ongoing regarding the safety of silicone gel-filled breast implants, with limitations in the existing evidence.[12] As a specialty, plastic surgery must increase its awareness of evidence-based practice.[13] It remains the specialty's duty to provide evidence to inform surgeons, patients, the general medical community, and public about the safety of its distinguishing medical device.[14] The purpose of this study is to comprehensively analyze long-term safety and implant-specific outcomes in patients with breast implants from the FDA LPAS database, including rare harms of CTD, neurological disease, autoimmune disease, cancer, self-harm, and reproductive health. Secondary outcomes include implant-specific complications, patient-reported outcomes, and compliance with imaging surveillance.

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