High Resolution Ultrasound in the Detection of Silicone Gel Breast Implant Shell Failure: Early Clinical Results

Goals/Purpose:

Many recent studies have brought into question whether Magnetic Resonance Imaging (MRI) is the best first diagnostic test for potential silicone gel breast implant shell failure and follow-up, and the FDA is re-evaluating their recommendations for clinical follow-up at 3,5 and 7 years with MRI. Regardless, there is a huge void in the clinical detection and simple follow-up of breast implants, and improved patient follow-up is necessary and important. Recent advancements in Ultrasound technology hardware, higher quality and greater resolution of the transducers, and software modifications have brought ultrasound back in the forefront of implant imaging and follow-up particularly with the concurrent advance of fourth and fifth generation devices. The purpose of this study is to begin to determine the accuracy, sensitivity and specificity of current High Resolution Ultrasound (HRUS) technology in the detection of silicone gel breast implant failure and to compare this new revamped technology to MRI.

Methods/Technique:

Initially in vitro data was obtained by utilizing various hardware ultrasound platforms including GE LOGIQ-9, followed by LOGIQ-i, LOGIQ-e and Venue-40 devices with various Megahertz heads ranging from 8-16 MHz. Both intact and intentionally cut shells in various models were scanned to determine the resolution, scanning ability and accuracy of the current devices. Next, intact and cut shells were scanned beneath discarded abdominoplasty skin flaps to simulate breast tissue and feasibility study completed, which has been presented previously. Next an initial pilot study of fifteen patientswas performed comparing the two diagnostic methods and an ongoing prospective study is underway comparing HRUS and MRI in patients proceeding to surgery for implant replacement.  The pilot study results and updated prospective study results will be presented.

Results/Complications:

All GE units studied easily detected both intact and intentionally divided shells in both the standard gel and highly cohesive gel devices. Although multiple types and array of transducers were able to detect shell failure in all models, the 12MHz head produced the best images at the normal depth range. The smaller laptop size units such as the LOGIQ-e, -i, and Venue 40 were found to be portable, less expensive and just as accurate as the larger LOGIQ-9 base unit. Fifteen consecutive patients presenting with MRI evidence of either intact or implant rupture were also all scanned with a 12 MHz transducer and all patients brought to surgery. In the initial pilot, both MRI and High Resolution Ultrasound have been 100% accurate in predicting implant shell integrity with the first 15 patients. We have initiated the prospective study and current patients enrolled will be presented and we plan to have the majority of our study completed for an update to present in May.

Conclusion:

New High Resolution Ultrasound can easily detect silicone gel breast implant shell failure in vitro with a wide array of transducers and hardware systems and with a high degree of accuracy. In addition in early clinical studies HRUS has an equivalent high degree of accuracy when compared to MRI. Particularly with recent MRI data in question, although early in the study, it appears that HRUS technology will provide enough detail to detect implant shell failure that may rival or be equivalent with MRI, certainly with enough accuracy to consider it as a good initial diagnostic test. Ultrasound has some limitations but with new and future technology evolving, a need for higher compliance rates for implanted patient follow-up exists. High Resolution Ultrasounds availability, accessibility, lower cost, dynamic real-time viewing, and use in multiple other applications specific to plastic surgery are clearly advantageous.

The images show a patient with a ruptured right breast implant with HRUS and MRI along with her intact left breast device and finding present at surgery.