Breast Augmentation

Breast Augmentation Study

Use of High Frequency Electrical Stimulation for Treatment of Pain and Swelling After Breast Augmentation in Adult Women

Principal Investigator: Dr. David Genecov

Background

Breast augmentation is one of the most common procedures performed by plastic surgeons in the United States. Over the past two decades efforts have been made to limit the discomfort associated with the procedure and to return women to their normal daily activities as soon as possible. The largest limiting issue in doing so is pain. Narcotics and muscle relaxants have undesirable side effects and recent advancements in non- pharmaceutical pain control appear promising. This report represents a pilot study to evaluate the use of non- invasive pulsed electromagnetic field (PEMF) therapy device in a double blinded randomized placebo controlled fashion supported by the North Texas Independent Review Board at Medical City –Dallas Hospital.

Study Execution:

Eighteen healthy women whom underwent breast augmentation entered the study. The procedures were performed for purely aesthetic considerations. All patients finished the study by completing and returning their pain data and postoperative diaries. Each patient received two ActiPatch PEMF breast devices not knowing whether they were sham (n=8) or active devices (n=10). They were placed on the operated breasts immediately post operatively and were worn for the next consecutive seven days. Postoperative pain data was obtained using a visual analog scale (VAS) and pain recording was performed twice daily during the study period. Pain medication use was also monitored, both narcotic and non narcotic.

Results:

VAS data showed statistically significant less am and pm pain in the active group from day one until the study end with p=0.004 using Friedman’s statistical analysis for each data set. Total opiate and analgesic use was no different between the two groups. In both groups the use of narcotics and analgesic medications decreased at similar rates during the study period.

Conclusions:

PEMF therapy for the treatment of pain following breast augmentation significantly reduces pain when compared to control. PEMF can provide a non-narcotic adjunct for the treatment of pain in breast augmentation patients.

Methods:

To begin the evaluation of PEMF in the treatment of pain in breast augmentation, a preliminary study was started. Devices were blinded by codes that were known only to the administrator of the study (MM) and not to the physician, nurses or the patients. The patients, ages 19-48, were counseled on entrance into the study and 18 agreed to be part of the study. IRB consents were signed after the information was provided. Breast augmentation was performed in the sub-muscular fashion via either an infra-mammary or peri-areolar approach. Surgery was performed by two surgeons with similar training and experience. Once the surgery was completed, the devices were applied directly to the breasts and secured with a surgery bra. The patients and their families received instructions for care and documentation.

Each patient provided pain evaluations using a VAS 2 hours after rising and prior to bed each day. Narcotic and analgesic use was recorded when used each day. The patients returned their information on their two week postoperative visit.

Discussion:

The PEMF devices were tolerated by all patients and there were no drop outs. Complete data was obtained from all patients and was available for statistical analysis. Initial VAS scores for the active devices were consistently lower than that for the sham devices both in the morning and evening scores. The daily use of medication was not different between the groups when evaluated on a day to day basis or as an aggregate. The opiate use by the active PEMF group was lower by day 5-7 but was not statistically significant. The same can be said for the analgesic group. The slope of change for the VAS scores was not statistically different between the two groups. This represents the sustained effect of the PEMF on the pain control for the duration of the evaluation.

Comparison with previous PEMF Study on pain and breast augmentation: Heden, Per and Pilla, Arthur a. Effects of Pulsed Electromagnetic Fields on Postoperative Pain: A Double Blind Randomized Pilot Study in Breast Augmentation. Aesthetic Plastic Surgery (2008), 32:660-666.

In this pilot study, the authors placed a large PEMF device around each breast in the post operative period. They had three groups, one with bilateral PEMF treatment, one with unilateral PEMF treatment and one with bilateral sham devices. A total of 42 patients were included with 14 in each group. There were no complications related to the devices and the devices were well tolerated by the patients. The study subjects were required to rate their pain twice daily using the visual analog scale, which is similar to our study. The length of the study was also seven days. Additional data was kept on pain medication administration as well. They demonstrated statistically significant improved pain control in the active group by day 3 that continued thru day 7. They also demonstrated a significantly decreased use of pain medication by day three.

These results are consistent with our study in many ways. The ActipatchTM was able to statistically reduce pain in the active group. However, the improvement in our study was seen by post operative day number one, not day three. In our group the total pain medication usage and the slope of medication use change were not statistically different although were numerically less. One difference between the two studies was the placement of the device. In the Per Heden study, the large devices were placed on top of the bras and surgical dressings. In our study, the devices fit directly into the pockets of the specially made test bras, thereby reducing the distance between the device and the area of intended treatment. It is possible that this treatment difference is what demonstrates the acute effect of the device. The comparison between the two studies favorably shows statistically significant improvement with the use of PEMF in the post operative treatment of breast augmentation and confirms the benefits of each.