The Morcellation "Debate" and the FDA 510(k) Process-A Call for Further Reform.

IMPORTANCE: Few gynecologic surgeons understand the mechanism by which surgical instruments are approved for human use and marketing or do they appreciate the central role they play in postmarket surveillance and reporting after instruments have come to market. OBJECTIVE: Using the experience with the uterine morcellator, this review will detail the Food and Drug Administration (FDA) system for approving surgical instruments and the potential pitfalls of this process. EVIDENCE ACQUISITION: Literature review and public documents from the FDA. RESULTS: The FDA 510(k) approval process for surgical instruments relies largely on postmarket surveillance as exemplified by the uterine power morcellator, which was approved before sufficient evidence was available regarding its potential harms. CONCLUSIONS: The current system currently transfers the responsibility of ensuring safety and efficacy to the public, patients, and providers. To minimize potential harm, the FDA needs to incorporate a greater standard of evidence into its framework for the approval and regulation of medical devices. The burden of these requirements should be borne at least in part by the companies bringing equipment to market. RELEVANCE: It is incumbent on all surgeons to be vigilant in their objective critical assessment of new instrumentation and report their outcomes after they come to market.

Morcellation equipment: past, present, and future.

PURPOSE OF REVIEW: This review was written in an effort to describe the evolution of power morcellation equipment from their creation to their current state. In addition, this review addresses the continuously evolving equipment involved with power morcellation and looks to describe where the field is headed in the future. In addition, recent professional and federal recommendations have changed the way power morcellation is being approached and has led to the development of contained morcellation systems, which, although in their infancy, are also being proven to be well tolerated options. RECENT FINDINGS: This article will review the most current research on electronic power morcellation and the multiple attempts to prove superiority from the many different types of equipment, and also the many different approaches to morcellation. In addition, with the adaptation to contained morcellation, this review will cover research focused on optimizing a containment system and the techniques involved. SUMMARY: In summary, this review is aimed at describing many of the currently available power morcellation products and contained morcellation systems in an effort to allow physicians to understand the different options available, and to discuss well tolerated, effective, and clinically proven techniques that can lead to improved surgical outcomes in the future.

Development and history of morcellators.

PURPOSE OF REVIEW: Controversy exists surrounding extraction of tissue in gynecologic surgery using morcellators following cases of disseminated uterine cancers discovered after the use of electromechanical morcellators. This chapter traces the history of tissue extraction in gynecology and reviews the evolving scientific data and opinions regarding the future of morcellation. RECENT FINDINGS: Since the initial Food and Drug Administration warning about morcellation in 2014, subsequent studies do not support the Food and Drug Administration's high incidence of occult uterine cancer. Current research continues, focusing on methods of contained tissue morcellation, both laparoscopically and vaginally. SUMMARY: Minimally invasive surgical techniques have revolutionized gynecology, drastically reducing the need for open procedures. To maximize patient safety while preserving the rapid recovery and low morbidity of laparoscopic and vaginal approaches, optimal methods of tissue extraction need to be developed and promulgated.