Clinical Trials Logo

Clinical Trial Summary

Breast augmentation surgery is currently the most common elective plastic surgery performed in the US. With regards to the surgical technique, there are 4 incisional sites available for breast augmentation, each with its advantages and disadvantages: Axillary, Periareolar, inframammary, and umbilical. The implant is inserted in either a subglandular (beneath breast tissue), submuscular (underneath the Pectoralis Major), or "dual-plane" (combination of both) manner.

Echocardiography is the most commonly used diagnostic test in cardiology for the evaluation of cardiac structure and function. Its use has increased dramatically in the last decades. We have encountered three women with congenital heart disease who have undergone breast augmentation, and their echocardiographic images were significantly limited after the implantation. There is only one case report in the medical literature suggesting that breast implants interfere with echocardiographic views .

The underlying physical property of the silicone breast implants that causes interference with the ultrasound beam during echocardiographic examination is not known and has not been studied. Similar to air in the lung but to a lesser degree, silicone breast implants appear to prevent penetration of ultrasound beams. The poor penetration appears to be persistent and unrevealing despite increase in gain or change in the ultrasound wave's frequency.

Many women elect breast augmentation for cosmetic reasons. Women with congenital heart disease who have undergone cardiac surgery may have breast asymmetry or distortion and desire augmentation accordingly.

Knowledge of the extent of impairment of breast implants to the echocardiographic examination is important for few reasons:

1. Women with heart disease who need echocardiographic follow up and wish to undergo breast augmentation should be consulted as to the limitation of the echocardiographic examination following the procedure.

2. Women without heart disease considering breast augmentation should be informed of potential echocardiographic interference, if echocardiography be needed in the future,

3. Different surgical techniques may cause different masking effect.

4. Different implants size and shape may cause different masking effect.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01945463
Study type Observational
Source Hadassah Medical Organization
Contact
Status Completed
Phase N/A
Start date October 2013
Completion date August 2016

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06013514 - Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Completed NCT00753922 - Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses Phase 3
Recruiting NCT05449587 - Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix
Completed NCT02302001 - Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain N/A
Completed NCT00905645 - Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study N/A
Completed NCT00756652 - Mentor MemoryGel Post-Approval Study
Terminated NCT01870869 - NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study N/A
Completed NCT00684749 - A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty N/A
Active, not recruiting NCT06079086 - Evaluation of the Clinical Evolution of Breast Increase Using Prostheses N/A
Active, not recruiting NCT03386682 - Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study N/A
Completed NCT01146275 - A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106 N/A
Completed NCT00663156 - A Prospective Study of Autologous Fat Grafting for Breast Augmentation N/A
Completed NCT00605670 - Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery N/A
Completed NCT01639755 - European New Texture Implant Clinical Experience With Shaped Breast Implants Phase 4
Completed NCT01639742 - European New Texture Implant Clinical Experience With Round Breast Implants N/A
Completed NCT04036487 - Effects of General Anesthesia on Quality of Recovery After Transaxillary Endoscopic Breast Augmentation N/A
Completed NCT01238601 - Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping N/A
Completed NCT03467724 - Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift N/A
Completed NCT02235285 - Asian Outcomes of Primary Breast Augmentation N/A
Completed NCT00689871 - Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants N/A