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The Effect of Breast Augmentation on the Quality of Echocardiography Test

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01945463
Enrollment
4
Registered
2013-09-18
Start date
2013-10-31
Completion date
2016-08-31
Last updated
2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Augmentation

Brief 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.

Interventions

None listed

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1\. Unwillingness to participate.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of women in which the breast implant will affect the quality of the Echo test.one monthThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026