Silicone Implant Illness: Science Versus Myth?

Rod J. Rohrich, M.D.; Jordan Kaplan, M.D.; Erez Dayan, M.D.

Disclosures

Plast Reconstr Surg. 2019;144(1):98-109. 

In This Article

Abstract and Introduction

Abstract

The purpose of this Special Topic article is to present the current state of scientific evidence related to the safety of silicone breast implants. There is presently overwhelming evidence to support the safety of silicone breast implants. Ultimately, the decision to obtain, keep, or remove breast implants is the choice of the patient. If a patient chooses to have her breast implants removed, it is important to find a board-certified plastic surgeon with expertise in breast surgery. Ongoing studies are strongly encouraged in all areas, from cancer detection to autoimmune disease, as we strive for improved patient safety, patient awareness, and patient education. To the best of our body of scientific knowledge to date, there have not been any concrete or evidence-based studies or peer-reviewed data concerning the formation of a new syndrome: "silicone implant illness." Silicone breast implants are used in nearly 300,000 breast augmentation and 100,000 breast reconstruction operations annually in the United States.[1] Silicone gel–filled implants were first approved by the U.S. Food and Drug Administration in 1962. Since that time, few medical devices have been studied as closely for their safety and associated adverse outcomes. Despite multiple generations of implant shells and gel fillers, the basic components remain as originally designed.[2,3]

Introduction

In the 1980s, as consumer concern regarding silicone breast implant safety grew, the U.S. Food and Drug Administration's new surveillance system began to identify local complications associated with silicone implants in addition to several published case reports that described an association between cancer and connective tissue disorders in patients with these devices.[4] For more than 60 years, there has been controversy as to the safety of these devices, with more than 400 reports on various health conditions in association with breast implants.[5]

Ultimately, in 1992, the U.S. Food and Drug Administration determined that silicone implant manufacturers had not provided enough data to adequately address consumer concerns, and silicone implants were removed from the market. On their return, the U.S. Food and Drug Administration required all major breast implant manufacturers to conduct core studies to assess overall implant safety profiles.[6–10] Seven years after the U.S. Food and Drug Administration moratorium on silicone implants, the Institute of Medicine released a detailed report of the current literature entitled Safety of Silicone Breast Implants, which ultimately concluded that local complications were of primary concern and that, to definitively comment on systemic disease such as cancer or autoimmune disorders, further studies were needed, as there was currently a paucity of significant, well-controlled studies.[4]

The Institute of Medicine report was the first step toward the return of silicone breast implants and was instrumental in clarifying the scientific evidence and identifying information gaps on the safety of these devices. Since their return, there has been ongoing extensive research concerning their safety, which is in part attributable to the U.S. Food and Drug Administration's stipulation that the two manufacturers of silicone breast implants at that time, Allergan plc (Dublin, Ireland) and Mentor Corp. (Minneapolis, Minn.),[11] conduct large postapproval studies to guarantee that these potential long-term risks did not go unmonitored.[12]

The extent of our knowledge on prior safety concerns has expanded since the U.S. Food and Drug Administration's decision to remove silicone breast implants from the market.[4,13] It is our responsibility as plastic surgeons to hold industry and one another accountable for the care of our patients by increasing awareness of evidence-based practices.[12,14,15] This Special Topic article reviews the current literature regarding the safety of silicone breast implants and the concerns that remain about these devices in light of recent consumer and social media about the possible existence of a "silicone implant illness" syndrome, an entity that currently has no clear definition but has been popularized by both health care providers and the media.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....