DAVID SIEBER, M.D.
Chair, Grant Committee
Aesthetic Surgery Education and Research Foundation
My name is David Sieber, and I’m a board-certified plastic surgeon in private practice in San Francisco. I have no financial disclosures.
I’m the Chair of the Grant Committee for the Aesthetic Surgery Education and Research Foundation, and I serve as a peer-reviewer for the Aesthetic Surgery Journal and the Journal of Plastic and Reconstructive Surgery.
I perform only cosmetic breast implant surgery, which makes up approximately 40% of my surgical practice.
The FDA has asked you to discuss MRI screening recommendations for silicone breast implant silent rupture and whether these recommendations should be changed.
Screening is very important; however, many women are not compliant with the current recommendations.
I am here to advocate an alternative screening method, high-resolution ultrasound, which we believe will result in greater compliance and subsequent clinical benefit.
There are approximately 300,000 women who undergo breast augmentation surgery in the United States annually.
Based on the June 2011 guidance document, the FDA currently recommends that women with silicone implants get their first breast MRI 3 years after they receive the implants and every 2 years thereafter to detect silent ruptures.
This recommendation is based on core studies in which MRI was used to detect implant rupture and to assess implant shell integrity.
In August of 2011, an FDA Advisory Panel noted the current scientific data and recommendations for MRI screening for silent rupture and questioned whether much was gained by this recommendation.
There was a concern expressed about cost to patients and mentioned false positive findings and whether information about silent rupture would change practice, such as decisions about removal of the device.
In my clinical experience, despite the recommendations by the manufacturers and the FDA, patients are not having the MRIs performed for a variety of reasons.
The most common reason is cost. Since much of my practice is cosmetic augmentations, an MRI is often not covered by insurance carriers, with the average out-of-pocket costs of approximately $2,600 per MRI.
Over the course of 10 years, patients would be spending over $10,000 in order to follow the current FDA recommendations.
In a paper cited in the FDA update on silicone implants, written by Gorczyca, there’s very little attention paid to valid alternatives to MRI, such as high-resolution ultrasound.
A paper published by Bengston in 2012 demonstrated that evaluation of implant shell integrity was able to easily be learned and performed using an in-office based ultrasound.
An additional paper published in 2017 by myself and Adams also confirmed in-office ultrasound could easily and effectively be implemented to follow breast implants, as well as identify gel implant shell failure.
So why then are we recommending to our patients a test which is often cost prohibitive and has a very low compliance rate?
In my professional experience, high resolution ultrasound may act as a better screening alternative to MRI due to its accessibility, which may lead to a higher patient compliance.
Thank you for your time today.
[Open public comment given by Dr. David Sieber, M.D., at the General and Plastic Surgery Devices Panel, FDA White Oak Campus, Building #31, Great Room, on March 25, 2019. The title of this article does not constitute part of the speaker’s presentation to the FDA Panel, and any hyperlinks within the text or text appearing in brackets were added for clarity or ease of use by editors.]