Instructional Course: Officed-Based High-Resolution Ultrasound for the Plastic Surgeon

Published:November 03, 2020DOI:https://doi.org/10.1016/j.cps.2020.09.011

      Keywords

      Key points

      • MRI has long been the gold standard for breast implant imaging a shell disruption.
      • High-resolution ultrasound (HRUS) imaging is emerging as the leader in breast implant imaging and follow-up, surpassing MRI in specificity and sensitivity.
      • HRUS is efficient, safe, affordable, and highly accurate and can easily be incorporated into a plastic surgeon’s office and postoperative routine.
      • Breast implant technology with higher-fill implants, increased gel cohesivity, and standard shell thickness is merging with marked improvements and accuracy of HRUS systems, making imaging of current sixth-generation implants easier to diagnose any complications.
      • Plastic surgeons, seeing and experiencing breast implant complications, are best suited to understand, diagnose, and treat breast implant complications.
      • For any equivocal ultrasounds, an MRI or additional testing may be sought prior to surgery if the plastic surgeon is relying solely on the HRUS read for surgery.
      • This technology can transform a surgeon’s practice more than nearly any single technology and is easily incorporated into a plastic surgery practice.
      • Since 2006, more than 6000 patients have been scanned, with more than 1100 patients’ implant status confirmed in surgery with more than a 97% predictive value.

      Introduction

      High-resolution ultrasound (HRUS) has been the single most significant addition to my plastic surgery practice in the past 2 decades. I have performed well over 5000 HRUS since 2006 and have very high degrees of accuracy in confirming over 1100 breast implant status intraoperatively. When surgeons incorporate this technology into their practices, they will literally be unable to remember what their life was previously like without it. HRUS is easy to incorporate into the patient flow of the practice and has a predictable, quick learning curve. The patients truly love coming in for their follow-up exams and find the scans of great value. Not only is it an effective marketing tool but also it improves overall patient follow-up and implant studies. It allows the surgeon to know and plan for upcoming revision surgery concerning implant status. Removal of a ruptured implant is a much different operation than exchange of an intact implant. How does a surgeon plan for the exchange time and cost wise? In addition, whoever diagnoses the rupture performs the revision, so the technology has paid for itself in just 2 to 3 patients.
      Education on how to perform and read implant ultrasounds is dramatically improving as is the development of a network of plastic surgeons performing these scans. Ultrasound studies are underway to more broadly confirm the experiences of early surgeons who have embraced this technology. HRUS is most commonly used for breast implant follow-up but will also transform seroma management in your body-contouring patients. It easily demonstrates the differences between generalized edema versus fluid. How many surgeons have traumatized patients with seroma-seeking needles but found no fluid? I certainly have. Ultrasound solves this issue and eliminates the morbidity in these patients. HRUS is dynamic and not just a snapshot in time. The breast can be compressed to help define a fold versus a true rupture. In addition, plastic surgeons are best suited to perform HRUS because they are the most familiar with breast implants, capsules, pericapsular fluid and tissues, and what these devices look like in situ because they see them every day. Radiologists and x-ray technologists simply do not have the clinical experience of evaluating these devices like we do.
      The Food and Drug Administration (FDA) has finally given HRUS the green light in making it an alternative to MRI for screening asymptomatic patients.
      Breast implants–certain labeling recommendations to improve patient communication. Draft Guidance for Industry and Food and Drug Administration Staff.
      New implant companies bringing their devices into the US market will have 5 to 6 years before the FDA recommendations to begin scanning their new implants 5 years after implantation. My prediction is that by 2025 to 2026, the accuracy data for evaluating breast implants with HRUS will have surpassed MRI, and HRUS devices will be utilized daily in nearly every plastic surgeon’s office.
      This is a review of the current state-of-the-art of HRUS and of how to incorporate ultrasound into your practice along with some clinical examples and data collected over the past 16 years.

      Integrating High Resolution Utrasound Into Your Plastic Surgery Practice. American Society of Plastic Surgeons Breast and Body Symposium. Miami, July 18, 2019.

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      This includes a retrospective data review of some of the current largest series in the United States. I am a founder of PS Imaging, which is a consulting group who’s vision is to develop and spread the use of high-quality HRUS systems and images, to create a networking system, to help educate each other, developing large clinical experiences merging ultrasound images with actual clinical correlation, and working on a credentialing process with our societies for the benefits of plastic surgeons and our patients.
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      My journey with ultrasound began when I met my son Nate for the first time visually at 28 weeks in utero and watched him yawn, have his fingers and foot in his mouth at the same time, and suck his thumb. Visualizing the quality of the images, my first thought was, “This is amazing!” and my second was, “I wonder what applications there are for HRUS in plastic surgery.”
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      Everyone needs a better solution to evaluate breast implants: The FDA needs it, implant companies need it, plastic surgeons need it, but mainly our patients really need it.
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      Breast implant technology with new sixth-generation implants with strong consistent shells, overfilled devices, and highly cohesive fillers and improvements in ultrasound technology are MERGING to create the perfect environment. The Age of Ultrasound begins now, and now is the time to bring this technology into the forefront.
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      Along with breast implant shell and body/breast seroma diagnosis and management, HRUS will have many additional applications in plastic surgery. ADM, Acellular Dermal Matrix.
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      The future is limitless, including adding Artificial Intelligence into this platform and having computer backup for the surgeon’s evaluation, and adding elastography and applying color to different tissue densities.
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      It is an entire system and requires a robust, reliable hardware component, a high-frequency transducer of 12 to 18 MHz, and a large high-quality monitor or screen to visualize the images and comparable knowns.
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      Recent FDA guidance has encouraged surgeons to evaluate and use HRUS for screening of asymptomatic patients.
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      Now is the time to learn, embrace, and incorporate ultrasound technology into our practices.
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      FDA guidance is moving toward HRUS and opening the door for ultrasound to be the primary screening technology with MRI for backup.
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      Having a library of images of various shells and intact versus ruptured implants will be helpful particularly when first beginning with HRUS.
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      There are many reasons to incorporate HRUS into your practice, and a strong case can be made for the marketing potential alone. However, money will not be your most important reason.
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      So here are some of the first images I recorded on ultrasound. These are images of a textured implant showing a “fuzzy” shell and an intentionally cut implant shell. Notice the “Railroad track” appearance. This is the ultrasound waves imaging the inner and outer shell and reflecting back and creating a dark “Oreo”-type appearance canceling out the sound waves in the center of the shell image.
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      Shown are additional images of early images visualized of intact and ruptured implants.
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      Early images of a ruptured smooth implant on the left and an intact shaped textured implant on the right on both HRUS and MRI.
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      This is a series of a patient 10 years following placement of a textured shaped implant with new “softening” of her right breast.
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      She shows evidence of rupture of her right breast implant on HRUS and MRI and an intact implant on her left side.
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      Preoperative imaging was confirmed intraoperatively with the shell disruption in the exact position at the vertical level of the nipple-areolar plane as seen on HRUS preoperatively.
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      One of the main advantages of HRUS is that the exam is Dynamic. Folds can be easily smoothed out or potential ruptures accentuated, whereas MRIs are a snapshot in time. This image was read ruptured on MRI but is clearly just a fold on HRUS.
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      Registration marks, both “dots” and “lines,” are easily identified, and rotations can also be detected even if not visualized clinically.
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      Breast and body seroma management is revolutionized. Fluid collections can easily be identified as large dark regions, and needles can be seen accessing the fluid and draining the cavities completely under ultrasound guidance. It also saves you and the patient a great deal of pain and distress if no actual fluid is present.
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      Novel new technologies to internally close down surgical spaces have been launched on the market in the United States that may, in fact, eliminate internal fluid collections, allowing for early and complete tissue approximation. This is what “internal tissue closure” and early healing look like on ultrasound of the abdominal skin flap/abdominal fascia healing plane.
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      Concerning ultrasound, the “gold standard” is actually what is observed in surgery compared with the “test outcome,” in our case, what HRUS shows preoperatively.
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      Here are the results of our first 680 patients who had their preoperative HRUS reading compared with what was found in surgery. The first 100 patients had both a board-certified radiologist and a primary surgeon evaluate all patients. Both were 100% accurate. In the next 580 patients, there were 5 false positives in old implants with marked underfilling and/or double lumen silicone implants or severe capsular contracture. There were no false negatives.
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      Additional clinical experiences continue to grow utilizing HRUS.
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      HRUS is highly accurate with most of the false positives coming early in the surgeon’s experience. In scanning over 5000 patients now in my practice and confirming ruptured or intact devices in surgery, I have a 97% sensitivity with only 7 false positives (true positive) and 99% specificity (true negative) in my breast revision practice.
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      There are many publications emerging showing higher and higher accuracy rates and clinical experiences with HRUS.
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      This is a 48 year-old patient with capsular contracture and intact textured round implants on HRUS and confirmed in surgery. The quality of new HRUS systems along with increased shell and filler characteristics allows for even more improved accuracy and outcomes.
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      A patient with 15-year-old smooth responsive low-profile implants shows rupture on HRUS, which was confirmed in surgery. When surgeons know they have a ruptured implant, they can plan better for time and cost as well as apply a plastic drape directly on the skin for protection and to facilitate implant removal utilizing a irrigation syringe placed backward into the capsule and then placing the syringe to suction.

      Summary

      HRUS is one of the rare technologies that comes along on in our practice lifetime that will truly transform our entire specialty. Once a plastic surgeon decides to incorporate HRUS into their practice, their practice and those of their patients will never be the same. HRUS is easy to learn, easy to integrate, safe, highly accurate, and practice changing. The final slide in my first national presentation in 2007 stated, “High-resolution ultrasound will be in every plastic surgeons office in the future; it is just a matter of time.”

      Incorporating high resolution ultrasound into your plastic surgery practice. American Society for Aesthetic Plastic Surgeons, San Diego, CA, May 4, 2008.

      I believe the time is now!

      References

      1. Breast implants–certain labeling recommendations to improve patient communication. Draft Guidance for Industry and Food and Drug Administration Staff.
        (Available at:) (Accessed September 22, 2020)
      2. Integrating High Resolution Utrasound Into Your Plastic Surgery Practice. American Society of Plastic Surgeons Breast and Body Symposium. Miami, July 18, 2019.

      3. Incorporating high resolution ultrasound into your plastic surgery practice. American Society for Aesthetic Plastic Surgeons, San Diego, CA, May 4, 2008.