March 28, 2019

Destounis Spurs Discussion on Breast Implant MRI at FDA Meeting

At a highly anticipated two-day meeting on the benefits and risks of breast implants, radiologist Stamatia V. Destounis, MD, FACR, reported on the ACR Appropriateness Criteria® and the role of magnetic resonance imaging (MRI) in detecting breast implant rupture in an invited presentation before the U.S. Food and Drug Administration (FDA)’s General and Plastic Surgery Devices Panel.

The FDA currently recommends that patients have their silicone gel implants evaluated by MRI for silent rupture, beginning at three years post-implantation and every two years thereafter.

In contrast, Destounis, who represented the ACR as chair of its Committee on Breast MR Accreditation, informed the panel that the ACR Appropriateness Criteria recommend the following: For asymptomatic women (any age) with silicone implants, no imaging is recommended for implant evaluation.

Panel members discussed many considerations outlined in the ACR’s Appropriateness Criteria on Breast Implant Evaluation and in Destounis’s remarks during their deliberations considering whether the FDA should retain its current recommendation for MR evaluation of asymptomatic patients.

The panel ultimately suggested that the FDA should eliminate its recommendation for screening MRI to identify silent silicone implant ruptures in asymptomatic patients and instead consider recommending later and less frequent ultrasound evaluations for patients without symptoms. It suggested that breast MRI continue to be recommended for evaluating symptomatic patients when rupture is suspected or when ultrasound suggests rupture.