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High-resolution ultrasound (HRUS) is finally being recognized as a critical technology in our plastic surgery practices for identifying the status of silicone breast implants in our patients. The main barriers to adoption of HRUS have been hardware costs, perceived medicolegal issues, lack of FDA recognition and approval, perceived extra evaluation time, perceived inaccuracies or fear of missing a rupture, perceived difficulty of reliably performing the scan, and incorporating this technology into our practices. The costs of these new systems are low, ranging between $2000 and $10,000. Whoever diagnoses the rupture performs the revision, and booking just 1 or 2 cases pays for the system. The authors and I have worked with Robert Aicher, the former general counsel for the American Society for Aesthetic Plastic Surgery, to develop a specific informed consent document that is available to members. In addition, I tell all my patients I am not a radiologist and can only screen the surface of the implant. HRUS can provide additional clues along with the type, style, and age of the device to help determine if the implant is intact or not. Key society members have worked very hard with the FDA to obtain recognition and approval of HRUS as a screening option, along with magnetic resonance imaging (MRI), in postoperative silicone breast implant follow-up.1 HRUS is easily incorporated into a patient’s postoperative visit, with my ultrasound times now being less than 3 minutes. I perform their scan while asking them about their kids, new dog, new house, and how life is going. Patients appreciate and really require an office-based diagnostic test that can provide them piece of mind about the status of their device, and give them a very positive take home point: “Your implants look GREAT!” Ultrasound also gets them back in the office, exposing them to other products, nonsurgical procedures, and additional future surgical procedures.
This research and ongoing surgeon experiences show that the accuracy of HRUS is extremely high and that surgeons become more accurate after just 60 scans. I would recommend that surgeons bring their system into the operating room and scan their patient’s implants just before surgery, which provides immediate feedback inside the body of what they visualized on ultrasound, and decreases the learning curve. In addition, it is important to note that the reviewers found 96% specificity of their scans, so there are minimal false negatives. When an implant scans as intact, it is nearly always intact.
Most of their patients had relatively current generations of implants. With the current generation of devices, it is actually more difficult to make an incorrect diagnosis than an accurate one. Both the ultrasound technology, particularly the quality of the transducers, and the higher cohesivity and percentage of gel fill of the shell lead to much lower false positive and false negative rates.2 Even with equivocal or unsure findings, I would argue that older implants should be explanted or exchanged anyway. Patients with older devices may have thinner and involuted shells that can make them more difficult to evaluate, capsular contracture or calcified capsules, double lumen implants, or other issues that may be confusing.
The investigators found a specificity (true negative/condition negative) of 96.1% and a sensitivity (true positive/condition positive) of 85.2%, with an accuracy (closeness of a measured value to the true value) of 93.3%. Importantly, regression analysis showed what one would expect: the more one does, the better one gets (Figure 4, shown in original article on which this Commentary is written).3 On evaluation of 1104 implants, we have reported only 5 false positives, a 97.2% sensitivity, and 1 false negative, a 99.8% specificity (probably 100%, because the textured breast implant was likely ruptured during removal).4 We are currently updating our records on implant revisions with an additional 10 years of data, and in over 2000 implants, have had only 1 additional false positive confirmed at the time of surgery. The authors’ documentation of accuracy and improvement over time is very significant clinically and shows that plastic surgeons new to the technology learn quickly, further breaking down some of the barriers to adoption. Accuracy also increases over time.
The authors show many excellent images of intact and ruptured devices. Although these are not the focus of this study, it is very helpful to show how false positives typically occur in earlier generation devices. Additional scans that may cause confusion include older double lumen implants, older implants with convoluted folded shells, significant capsular contracture, and flipped devices where the mandrel patch fuses into 1 thin shell.
The key to identifying a rupture is to first identify the shell, which looks like an “Oreo” or “railroad track,” and make sure that one can see the shell up against the capsule. This shell is approximately 1.1-mm thick and appears split, because when the sound wave hits the inside of the shell it bounces back and cancels out a portion of the outside of the shell, which gives a dark black appearance between the shell surfaces.5 It is not the barrier protection layer that is visible. Next, the surgeon should look for any shell layers down in the body of the implant, with accompanying gel outside the implant shell, between the collapsed shell and the capsule. This usually produces a “snowstorm” pattern of the extra-shell gel, and occasionally vacuolization of the gel-fractured silicone. Ultrasound is a dynamic test, vs a static MRI, and therefore folds of the shell can be rolled out flat, in a situation in which the radiologist may be calling an acute fold a rupture. Other clues include visualizing the shell next to the capsule as well as an internal shell with double lumen devices, and the coalescence into a thin 1-piece shell in a flipped device.
The main weakness of this study is the limited number of patients and implants studied; however it conclusively shows that HRUS skills are transferrable and can be easily learned, and that accuracy improves over time, after a minimum of 60 patients. This study certainly adds to the accumulating data from multiple new HRUS users, demonstrating the significant impact of ultrasound on our specialty. I have heard Dr McGuire state from the podium on multiple occasions that “HRUS has been the single best technology I have purchased for my practice,” and that “I don’t remember what my practice was like before HRUS and how I managed patients efficiently.” I could not agree more.
Everyone needs a better breast implant screening method. The FDA needs it. Implant manufacturers need it. Plastic surgeons need it, and most importantly our patients need it. There is no question that HRUS is the answer to this need. The authors should be congratulated for adding to the continuing growth of literature supporting ultrasound, which is becoming the gold standard for the screening and diagnosing of breast implant–related complications. In 2008 our research on HRUS in the diagnosis of breast implant shell failure was recognized by our society with the Tiffany Award. The very last slide of that presentation was: “In the future, every plastic surgeon will have an ultrasound machine in their office evaluating implants and treating seromas … It's just a matter of time” (Supplemental Figure).6 It has taken much longer than I anticipated, and we are not there yet, but with this research and future additional studies I am confident that this statement will become a reality.
Supplemental Material
This article contains supplemental material located online at www.aestheticsurgeryjournal.com.
Disclosures
Dr Bengtson is the cofounder and chief medical officer of ICSurgical (Grand Rapids, MI), and cofounder of Plastic Surgery Imaging (Grand Rapids, MI).
Funding
The author received no financial support for the research, authorship, and publication of this article.
References
US Food and Drug Administration.
