Imaging and surveillance in patients with breast implants


Introduction

Following initial interest in ultrasound and breast implant evaluation in the 1980s, mainly in the UK, there has been very little research or clinical experience reported in our specialty. The final slide of the first national presentation of high resolution ultrasound (HRUS) in 2008 stated: “High Resolution Ultrasound will be in every plastic surgeons office at some point in the future …” However, integration of HRUS into plastic surgery has been a very slow process. In 2021, there appears to be a renewed interest with more ultrasound companies and surgeons finding new ways to utilize ultrasound. One of the core reasons is the convergence of technologies. As breast implant technology continues to improve with stronger more consistent shells, higher fill volumes, and more cohesive silicone fillers, HRUS is improving with significant advances in the ultrasound technology. This convergence is creating significant and high degrees of sensitivity and specificity with this technology, exceeding, in most cases, prior magnetic resonance imaging (MRI) data ( Tables 13.1 & 13.2 ). Gone are the days of thin undulating shells, markedly underfilled implants, double lumen implants and high rates of capsular contracture, that can decrease the accuracy of ultrasound, creating false positives. These older implants have many reasons for replacement other than shell failure, including their age, but in evaluating current state-of-the-art breast implants, it is becoming more difficult to make a wrong diagnosis verses a correct one.

Table 13.1
Comparison of imaging modalities
Mammography Ultrasound MRI
Rupture Saline-shell collapse
Silicone – intra/extra capsular
Horizontally stacked echo lines Linguine sign
Capsular contracture (CC) Spherical not oval, bulge Thick echogenic capsule Increased anterior-posterior (AP) diameter
Periprosthetic fluid Echo patterns Increased T2 signal
Autologous fat Microcalcifications, radiolucent masses Echogenic cysts, hypoechoic solid Architectural distortion, mass
CC – ultrasound: the presence of horizontally stacked echogenic lines corresponding to the displaced envelope within the anechoic silicone gel, or the “stepladder sign,” may be seen, which is in contrast to the normal vertical extensions of radial folds. Magnetic resonance imaging (MRI): increased AP diameter may be seen.
Rupture – MRI. The ruptured envelope is seen as multiple, low signal curvilinear lines within the high-signal silicone gel on T2-weighted and silicone-sensitive sequences, often referred to as the “linguine sign”.
Autologous fat – mammographic findings include scattered microcalcifications, single or multiple radiolucent masses with or without peripheral eggshell calcification, and spiculated masses. Sonographic findings are variable, ranging from simple or complicated cysts with low level internal echoes to cysts with an echogenic anterior margin and associated posterior shadowing resulting from calcification or a hypoechoic solid mass. MRI: calcifications may occasionally be seen as focal signal voids. Fibrosis is seen as focal architectural distortion or as a spiculated mass. Fat necrosis can show enhancement on MRI, with more intense enhancement observed in the early stages of fat necrosis.

Table 13.2
Assessment of implant rupture
True positive False positive Sensitivity Specificity Positive predictive value
Clinical exam 5/12 7/12 42% 50%
Ultrasound (US) 6/12 1/12 50% 90% 86%
Magnetic resonance imaging (MRI) 10/12 1/12 84% 90% 91%

Review of 60 implants/12 ruptures. US and MRI had a concordance of 87% across the group, coming to the same diagnostic conclusion in 52 ⁄ 60 implants.
Implant rupture rate in this group was 20%. The patients in this study were self-presenting and symptomatic, and hence this may not be a true reflection of the incidence of rupture in a more general implant population.
Ruptured implants in this group were older implants, consistent with the literature.
The cost of US is significantly less than MRI, which is of increasing importance in a cost-effectiveness driven ⁄oriented health service.
Perhaps the greatest limitation of US is that it is highly operator dependent, and in our study there was a 50% sensitivity, meaning significant numbers of false negatives i.e. missed ruptures. US proved to be just as specific as MRI, suggesting that if US detects a suspected ruptured implant, it is extremely likely to be ruptured.
Sensitivity : the true positive rat. Sensitivity = true (+) / true (+) + false (−). Probability of a + test given that the patient is ill.
Specificity : the true negative rate. Specificity = true (−) / true (−) + false (+). Probability of a (−) test given that the patient is well.
We therefore recommend use of MRI in circumstances where clinical suspicion is high.

Everyone needs improved implant screening including the Food and Drug Administration (FDA), implant manufacturers, and plastic surgeons, but particularly our patients. In October 2019, the FDA removed the prior MRI requirement for breast implant follow-up at 3, 5 and 7 years following implantation and recommended HRUS as an alternative for asymptomatic screening of implants. Current recommendations are for HRUS for screening asymptomatic patients with a diagnostic MRI for any suspected rupture. As clinical data and experience continues to grow, HRUS may well overtake MRI as the best and most accurate “gold-standard” method to diagnose shell abnormalities along with fluid collections.

There have been some recent excellent articles describing the basics of HRUS and background directed to plastic surgeons and plastic surgery applications. HRU evaluation requires a system. The system includes an ultrasound hardware platform, a high resolution transducer 12 MHz or higher, a software program and a display. There are several systems on the market today that create consistent high quality images to screen and diagnose shell abnormalities accurately ( Fig. 13.1 ). Along with shell failure, HRUS can determine whether an implant shell is textured or smooth ( Fig. 13.2 ), evaluate capsular thickness or visualize acellular dermal matrices (ADM) ( Fig. 13.3 ) and whether any fluid is surrounding the device ( Fig. 13.4 ).

Figure 13.1, Intact smooth silicone implant.

Figure 13.2, Intact textured silicone implant.

Figure 13.3, Ruptured smooth implant with thick capsular contracture surrounding the implant.

Figure 13.4, Fluid collection surrounding a macrotextured implant.

One of the main goals for the future is to integrate HRUS more effectively and efficiently into our practices. Dedicated systems for both the clinic and the operating room are very useful.

Particularly when surgeons are just starting out with ultrasound, it is helpful to image the patient directly on the table just prior to making an incision to confirm exactly what is being visualized on ultrasound and how it appears clinically. Operating room devices may also be utilized for ultrasound-guided transabdominal placement (TAP) of Marcaine or Exparel ( Fig. 13.5 ), and facilitation of fat transfer. Performing HRUS on every revision breast implant patient immediately prior to surgery, which allows for direct feedback on what is visualized on ultrasound, improves individual accuracy and allows for maximum surgeon education. In the clinic it is easy to integrate HRUS into a surgeon’s follow-up examination as described ( Algorithm 13.1 ). In addition, whoever diagnoses the ruptured implant performs the revision procedure and after two or three procedures the surgeon has paid for the technology. In aesthetics, surgeons typically are not charging for the procedure but a set fee, say, “$2000” may be placed on the surgery fee quotation and then subtracted out showing the HRUS follow-up has significant value. In insurance based reconstruction, HRUS-guided seroma drainage or implant follow-up may be coded and billed.

Figure 13.5, High resolution ultrasound-guided transversus abdominis plane (TAP) block for abdominoplasty pain control.

Algorithm 13.1
Algorithm for high resolution ultrasound breast revision.

Integrating HRUS into your plastic surgery practice

Plastic surgeons are only just realizing the potential benefits of in-office HRUS. Countless busy medical and surgical practices that require fast and accurate evaluation of soft tissues, joints, vessels, nerves, surgical sites, indwelling lines and drains, as well as implanted devices, are incorporating HRUS into their practices, often eliminating the need for referrals to a radiologist as they learn to image and interpret what they see. As surgeons, we have the opportunity to rapidly advance our ultrasound skills by routinely performing ultrasounds on as many implant patients as possible, documenting the image, and comparing with intra-operative findings at the time of revision. All breast implants will eventually fail and it is essential that surgeons who perform breast implant procedures have an accurate and reliable means to image their patients as their implants age. HRUS is a cost-effective, dependable method for the evaluation of patients in the office setting.

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