FDA Disputes Breast Implant Study
Posted 14 September 2018 | By
The US Food and Drug Administration (FDA) is raising concerns with a recent study’s methodologic and bias issues, with the director of FDA’s Division of Surgical Devices raising the concerns.
The latest issue of Annals of Surgery
includes a report on the long-term outcomes of 100,000 patients with breast implants in FDA-mandated post-approval studies that FDA previously assessed.
“Unfortunately, as the authors acknowledge, they failed to account for methodologic differences between studies, inconsistencies in the data, differential loss to follow-up, confounding and other potential sources of bias. Because of these significant methodological shortcomings, the report’s conclusions should be viewed with caution,” wrote Binita Ashar, a general surgeon and the director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health.
She also goes on to explain what FDA has done with respect to breast implant safety and what more is coming in the future.
“FDA has worked extensively to monitor, assess and take action to protect patients with regard to breast implant safety over the last several decades,” Ashar wrote. “We have regularly communicated about risks associated with breast implants, such as capsular contracture, implant rupture and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”
She also noted that in the future, FDA would like to have active surveillance capabilities, which is why the agency is working with breast implant registries and with other partners to establish the National Evaluation System for health Technology
for more postmarket monitoring.