FDA committed to studying breast implant safety

By Dr. Binita Ashar, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health Choosing to obtain a breast implant, whether for augmentation or reconstruction, is a deeply personal choice, from the initial decision to undergo breast implant surgery to the size, material and surface texture. These types of decisions should be discussed between a patient and their provider in a transparent and balanced way with clear information about the benefits and risks of the breast implants and the procedure. As a public health agency, we play an important role in ensuring that patients seeking breast augmentation and breast reconstruction have accurate information regarding the benefits and risks of breast implants to make informed decisions on whether implants may be right for them. Part of this role is to continuously monitor the safety of devices, like implants, once they are being used in patients, including examining adverse event reports that are submitted to the agency as well as reviewing postmarket studies and available scientific literature to enhance our understanding of a device’s benefit-risk profile. The FDA has worked extensively to monitor, assess and take action to protect patients with regard to breast implant safety over the last several decades. We have regularly communicated about risks associated with breast implants, such as capsular contracture, implant rupture and breast implant-associated anaplastic large cell lymph...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog FDA Voice Source Type: news