Grand Rapids, Mich. — A recent study suggests that portable, surgeon-performed, high-resolution ultrasound may have advantages over magnetic resonance imaging (MRI) when screening for implant failure.
Preliminary results of the study, led by Grand Rapids plastic surgeon Bradley Bengtson, M.D., show that high-resolution ultrasound provides excellent visualization of current fourth- and fifth-generation silicone gel implants in scanning models. In addition, in vivo surgeon-performed ultrasound accurately identified implant status and correlated with radiologist-performed ultrasound, MRI and surgical findings.
The Food and Drug Administration currently recommends MRI for device surveillance.
Phase 1 of the study evaluated several base and transducer systems, using them for both in vitro and ex vivo scanning model assessments of a variety of normal and damaged implant models. In phase 2, these technologies were applied clinically to provide imaging experience in three patients previously diagnosed with unilateral implant failure. In phase 3, a preliminary prospective evaluation was performed to compare the accuracy of MRI, surgeon-performed high-resolution ultrasound, and radiologist-performed high-resolution ultrasound scans in predicting the shell integrity of 29 implants in 15 consecutive breast implant patients who subsequently underwent secondary implant surgery.
In phase 1, all hardware models easily detected both intact and intentionally damaged shells in currently marketed fourth-generation responsive gel implants and in investigational, fifth-generation highly cohesive gel devices. Although multiple transducers were able to detect shell failure, the 12-MHz head produced the best images at the normal clinical depth range. Confirmatory scans in phase 2 correctly identified the side of rupture and were consistent with MRI and surgical findings. In phase 3, high-resolution ultrasound accurately predicted implant shell integrity in all 29 imaged breasts as confirmed at the time of surgery in both symptomatic and asymptomatic patients.
In a statement issued by the American Society for Aesthetic Plastic Surgery, Dr. Bengston says, “Our preliminary findings show that portable, surgeon-performed, high-resolution ultrasound is feasible for screening silicone gel breast implants, matching the capabilities of MRI in detecting shell failure. Although we are still working to define the role of this technology in the screening and diagnosis of patients with different silicone gel breast implant styles, there are several obvious benefits over MRI, including convenience, cost, availability, and dynamic, real-time visualization of the implant.”
The study appears in the February issue of Aesthetic Surgery Journal.
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