High-Resolution Ultrasound and Postoperative Surveillance of the Augmented Breast

Breast implants are not life-long devices. Breast augmentation surgeons need a tool to follow their patients as their implants age and evaluate patients with breast implant complications. Office-based ultrasounds are affordable, portable, and the learning curve is short. Studies show high-resolution ultrasound (HRUS) is as good or better than MRI in the detection of implant rupture. Surgeons who perform primary and revision breast augmentation are encouraged to incorporate HRUS in their practice.

Key points

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    In-office high-resolution ultrasound (HRUS) is becoming the standard of care for plastic surgeons performing breast implant procedures.

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    HRUS provides high sensitivity and specificity in the detection of implant rupture.

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    The rapid diagnosis of a late seroma using HRUS is essential in the diagnostic workup for breast implant associated anaplastic large cell lymphoma (BIA-ALCL).

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    The Food and Drug Administration guidance on breast implant surveillance recommends initial MRI or ultrasound at year 5 and every 2 years after to evaluate for silent rupture.

Abbreviations

ACR American College of Radiology
FDA Food and Drug Administration
HRUS high-resolution ultrasound

Background

All silicone breast implants have a lifespan and implant-related complications may develop years after the patient has undergone surgery. Implant rupture for the most part is clinically undetectable, and a capsular contracture may obscure an underlying rupture or seroma. In the United States, patients are eligible for an esthetic augmentation with silicone implants at the age of 22 years, yet their first radiologic screening for breast cancer may not occur until the age of 40 years. In 2019, the Food and Drug Administration (FDA) guidance on silicone implant surveillance was modified based on the need to capture more women who did not have insurance coverage for costly MRI and those with claustrophobic concerns. In-office HRUS is now becoming part of the preoperative evaluation for any patient going to the operating room for a revision or explantation procedure. Important patient education about the possible need for a capsulectomy and a more accurate assessment on procedure length can all be gotten from a 5 minute preoperative ultrasound. The rapid evolution of ultrasound technology in combination with the development of newer generations silicone devices has increased the specificity and sensitivity of ultrasound. In the last 10 years, surgeon education surrounding the use of HRUS in the plastic surgery practice has expanded and courses are frequently offered by both national and regional societies. Ultrasound education is now emerging as an integral part of the plastic surgery residency curriculum.

How ultrasounds work

Ultrasounds used in health care are designed to offer a range of functions depending on the target organ. All systems transmit a focused sound wave to a specific depth and interpret the echoes that are received. The transducer converts electrical signals from the ultrasound unit into sound waves and then back into electrical signals for the system to display on a monitor. Systems are becoming increasingly compact and portable; some systems are completely wireless and allow images to be portrayed directly on a phone or tablet. Most diagnostic medical ultrasound probes range between 1 and 12 MHz (cycles per second). Some transducers have added additional artificial intelligence to enable the user to distinguish more clearly tissue planes and identify and differentiate anatomic structures. The higher the frequency, the shorter the range of depths that can be evaluated. Most implants are located less than 5 to 6 cm beneath the skin and therefore a 7 to 12-MHz probe is best suited for the evaluation of a breast implant. The leading models differ not only in available megahertz but also the number of probe types—linear and array.

Breast implant surveillance versus breast imaging

When discussing the role of HRUS in a breast augmentation practice, surgeons and patients must recognize that breast implant surveillance with ultrasound is different from breast cancer screening. The use of ultrasound to assess breast implants is not performed with the purpose of screening for breast cancer and does not replace the need for routine annual mammography. Breast cancer is the leading cause of premature death in women aged over 40 years, and the American College of Radiology (ACR) recommends annual screening mammography at the age of 40 years and continuing past 74 years without an upper age limit. Separate from routine screening and diagnostic mammography, MRI has long been the gold standard for breast implant imaging. However, it is expensive and relatively time-consuming, leading to poor patient compliance. In 2019, the US FDA released updated guidance recommending the use of HRUS in asymptomatic patients to screen for silent rupture. The recommendation specifically states that HRUS can first be used in asymptomatic patients 5 to 6 years after the initial implant placement, and then every 2 to 3 years thereafter. International regulatory organizations including Agence Nationale de Sécurité du Médicament and European Committee on Quality Assurance and Medical Devices in Plastic Surgery have also made similar statements supporting the efficacy of HRUS for breast implant surveillance.

With the updated FDA guidance and advances in affordable and portable ultrasound equipment, more plastic surgeons are incorporating HRUS into their clinical practice. With this, more research has been done to assess overall accuracy of ultrasound to detect breast implant complications as compared to MRI. Research has shown that HRUS is highly effective at screening breast implants and is even more accurate at detecting rupture than MRI. When used by a trained plastic surgeon, the use of ultrasound to detect rupture has been found to have a sensitivity of 97%, specificity of 100%, and accuracy of 100%. This demonstrates that HRUS is a highly reliable imaging modality when evaluating breast implants. In addition to the better overall accuracy, there are many benefits to the patient in using HRUS instead of MRI for breast implant screening. Ultrasound is less expensive, less time-consuming, there are no claustrophobia concerns, and there are no restrictions for pacemakers, clips, or metal ports. This makes patients more amenable to routine screening and has resulted in much higher asymptomatic screening compliance.

Plastic surgeons integrating ultrasound in their clinical practice may still need to refer some patients to radiology for further imaging. Patients with any suspicious or concerning findings on ultrasound imaging, such as a new mass in the breast, should always be sent to a radiologist for further workup ( Fig. 1 A, B). Additionally, for plastic surgeons who are early in the learning curve period, an outside opinion from a radiologist may be recommended if the only reason the surgeon is bringing a patient to the operating room is because they believe they see a rupture. As plastic surgeons gain more experience and training, and corroborate their imaging findings with intraoperative findings, there will be less need for an outside radiologist.

Fig. 1

( A , B ) ( A ) Benign breast cyst. ( B ) Invasive lobular cancer.

A leading concern of many plastic surgeons is whether they need to obtain an informed consent prior to in-office HRUS. An informed consent policy is recommended to make certain that patients fully understand that they will undergo breast implant surveillance and not breast cancer screening. This consent should include the benefits, risks, and alternatives to using HRUS for breast implant surveillance as well as addressing the limitations to HRUS and how it is not a substitute for routine breast screening as recommended by the American Cancer Society and ACR. Surgeons are advised to check with legal counsel in their specific state to review the content of the consent prior to use in clinical practice. Finally, policies regarding fees for new patients versus existing patients are up to the individual practice.

The learning curve

One of the primary barriers to introducing HRUS into a plastic surgery practice is the lack of trained providers who can actually perform the ultrasound. Often after purchasing the required equipment, plastic surgeons are hesitant to start using their ultrasound fearing time constraints between patients and not understanding exactly what they are seeing. It is important that the ultrasound findings be accurately interpreted to make a proper diagnosis, and the surgeon is able to explain the findings to the patient. For many surgeons, the effort required to learn how to use an ultrasound may seem daunting or not worth the time, but it is apparent from prior research that there is a quick learning curve to using HRUS to examine breast implants. In a recent study, the surgeon’s learning curve was evaluated by reviewing 340 sequential readings in 2 breast augmentation practices shortly after purchasing their first ultrasound. The preoperative readings were checked for accuracy by comparing to the subsequent operative findings. It was found that the surgeons were able to reach over a 90% sensitivity and 80% specificity for diagnosing breast implant rupture after only 60 HRUS readings (30 patients). There was also a continued improvement in overall accuracy of HRUS over time, demonstrating better sensitivity and specificity than the standard by board-certified radiologist. HRUS can be easily incorporated into a clinical practice, and surgeons can quickly become proficient in using the technology.

Although consistent clinical use of HRUS has clearly been shown to improve accuracy at identifying breast implant complications, continued education with hands-on training is recommended for physicians who wish to become more confident and proficient. This training is available at both local and national meetings, as well as through manufacturer provided education. HRUS has consistently shown to be a useful tool in plastic surgery practices with many clinical indications, and there should be consideration to include ultrasound training into plastic and reconstructive surgery residency programs. There are numerous references in the general surgery literature that demonstrate the ease of incorporating ultrasonography training into general surgery residencies. Many of the general surgery training programs now provide both didactic and clinical courses to educate residents on how to perform ultrasonography on various anatomic locations. When surveyed, residents reported that after taking the ultrasound training courses and using the ultrasound on patients in the clinical setting, they felt improved confidence and self-efficacy in managing their patients.

Sep 28, 2026 | Posted by in General Surgery | Comments Off on High-Resolution Ultrasound and Postoperative Surveillance of the Augmented Breast

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