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

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.

breast pocket

Beauty; Breast implant

A pocket surgically created to hold the implant.

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.

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.

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 ...

necrosis

Beauty; Breast implant

Formation of dead tissue around the implant. Factors associated with increased necrosis include infection, use of steroids in the surgical breast pocket, smoking, chemotherapy/radiation, and ...