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CompletedNCT01945463Updated Nov 28, 2017

The Effect of Breast Augmentation on the Quality of Echocardiography Test

An observational study in Breast Augmentation, sponsored by Hadassah Medical Organization. Completed. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Hadassah Medical Organization · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
4
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.
02

Conditions studied

  • Breast Augmentation
03

In context

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women undergoing breast augmentation

Inclusion criteria

    1. Women with heart disease who need echocardiographic follow up and wish to undergo breast augmentation

Exclusion criteria

Exclusion Criteria:

  1. Unwillingness to participate.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
4 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Proportion of women in which the breast implant will affect the quality of the Echo test.

    The women will be gone through two Echo tests, the first before the operation and the second six weeks after the operation. The physician will compare the two tests.

    Time frame: one month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01945463
Lead sponsor
Hadassah Medical Organization
Responsible party
Sponsor
First posted
Sep 18, 2013
Start date
Oct 2013
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Nov 28, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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