Breast implant

Breast implant

A prosthesis used to alter the size, shape, and feel of a woman’s breasts for aesthetic enhancement.

Industry: Beauty

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Breast implant

Local complications

Beauty; Breast implant

Complications that occur in the breast or chest area.

Investigational device exemption (IDE)

Beauty; Breast implant

Clinical study performed to collect clinical data on a device to support approval of a marketing application. Approval of an IDE study does not mean approval to market the implant. The status of ...

Unsatisfactory style/size

Beauty; Breast implant

Patient or doctor is not satisfied with the overall look based on the style or size of implant used.

510(k)

Beauty; Breast implant

Application for marketing a device. In the past, breast implants were reviewed under the 510(k) process. However, they are now reviewed under the PMA process.

Submuscular

Beauty; Breast implant

When the implant is placed underneath the chest muscles.

Palpability

Beauty; Breast implant

Palpability is when the implant can be felt through the skin.

Nipple sensation changes

Beauty; Breast implant

An increase or a decrease in the sensation in the nipple or breast. This change can vary in degree and may be temporary or permanent. It may affect comfort while nursing or sexual response.