<< Back to the abstract archive
Comparing the FDA Premarket Approval of Breast Implants to Similar Devices Used in other Specialties
Ian L. McCulloch, M.Res
Cody L. Mullens, BS
Luke Grome, MD
W.T. McCllelan, MD
Cristaine M. Ueno, MD
A. Corde Mason, MD
West Virginia University School of Medicine
2019-02-06
Presenter: Ian McCulloch
Affidavit:
The majority of the work, project design, and writing on this project was conducted by the submitting student. Other authors have contributed to study design, data confirmation, statistical analysis, and editing in some form.
Director Name: Aaron C. Mason
Author Category: Medical Student
Presentation Category: Clinical
Abstract Category: Breast (Aesthetic and Recon.)
Purpose: Breast implants, like other Class III medical devices must demonstrate safety and efficacy in the Food and Drug Administration's (FDA) premarket approval (PMA) process prior to their release to consumers. The purpose of this study was to assess the PMA process of breast implants compared to similar Class III devices.
Methods: Summary of Safety and Effectiveness Data from the FDA PMA database was acquired, coded, and characterized for all breast implant devices approved between 2000-2018.
Results: Eight devices (3 saline-filled, 5 silicone-filled) were approved between 2000-2018 with a mean approval time of 1379 days. On average, devices required 4.6 pre-clinical studies and 3.5 clinical studies prior to approval. Clinical trials enrolled, on average, 429 participants per study. 25/28 studies disclosed participant demographics and all disclosed complication rate and type. Silicone filled devices required more clinical study (4 vs 2.66, p=0.0015) and approval time (1961.4 vs 409.33 days, p=.009) than saline-filled devices.
Conclusions: Our interrogation of the PMA database and review of published data reveals breast implants receive more clinical study, necessitate greater time for approval, and have more study participants than Class III devices utilized by other specialties such as ob-gyn, cardiology, orthopaedics, and radiology. Further, breast implants approved after 2006--particularly silicone-filled devices-- were more vetted than those approved prior to 2006. These findings suggest that the PMA process of breast implant devices is becoming increasingly thorough and is more rigorous than similar Class III devices, perhaps due historic and continued concern for patient safety.
