| Adjunct study |
Clinical study for silicone
gel-filled breast implant to address a public health need for
reconstruction and revision patients. The status of the implants in
an adjunct study is investigational. |
| Augmentation |
Includes cosmetic uses, such as to
increase breast size or for ptosis (sagging or drooping of the
breast) or asymmetry. Augmentation is one of three indications
(clinical uses) for breast implants. |
| Breast pocket |
A pocket surgically created to hold
the implant. |
| Calcification/ calcium deposits |
Hard lumps under the skin around the
implant. These can be mistaken for cancer during mammography,
resulting in additional surgery, either to biopsy the lumps or to
remove the implant. |
| Delayed wound healing |
Incision site fails to heal normally
or takes longer to heal. |
| Extrusion |
Skin breakdown with the implant
appearing through the skin. |
| Galactorrhea |
Inappropriate breast milk production
that may occur after breast implant surgery. In some cases, the
milk production stops by itself or after receiving medicine to stop
milk production. In other cases, the implant's) may need to be
removed to treat this complication. |
| Haematoma |
Collection of blood inside a body
cavity. Swelling, pain, and bruising may result. If a haematoma
occurs, it will usually be soon after surgery; however, it can also
occur at any time after injury to the breast. While the body
absorbs small haematomas, large ones may require the placement of
surgical drains for proper healing. A small scar can result from
surgical draining. |
| Inframammary |
Within the breast fold. |
| Intracapsular rupture |
Rupture of silicone gel-filled breast
implant in which the silicone gel remains contained within the
fibrous capsule. |
| Malposition/ displacement |
When the implant is placed
incorrectly during the initial surgery or when the implant has
moved/shifted from its original position. Shifting can be caused by
many factors, such as gravity, trauma, poor initial placement, and
capsular contracture. |
| Mastectomy |
Partial or complete removal of the
breast. |
| Mastopexy |
Surgical
procedure to raise and reshape sagging breasts. Women may also have
this surgery after an implant is removed and not replaced. |
| Necrosis |
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 excessive heat or cold therapy. |
| Palpability/ visibility |
Palpability is when the implant can
be felt through the skin. Visibility is when the implant can be
seen through the skin, such as the valve on a saline-filled breast
implant or the edge of an implant. |
| Periareolar |
Around the nipple. |
| Premarket approval (PMA) |
Application for marketing a device.
FDA must approve the PMA for the device to be sold on the market in
the U.S. |
| Ptosis |
Sagging/drooping of the breast. |
| Redness/ bruising |
Bleeding at operative site that
causes discoloration and varies in degree and length of time. This
is expected following breast implant surgery or breast procedures. |
| Reoperation |
Any additional surgery performed to
the breast or chest area. See the Local Complications &
Reoperations section for more details. |
| Revision |
This is replacement of an existing
breast implant. Revision is one of three indications (clinical
uses) for breast implants. |
| Rupture/ deflation |
Hole or tear in the shell of the
implant that allows for loss of the filler material from the shell.
See the Local Complications & Reoperations section for more
details. |
| Seroma |
Collection of the watery portion of
the blood around the implant or around the incision. Swelling,
pain, and bruising may result. While the body absorbs small
seromas, large ones will require the placement of surgical drains
for proper healing. A small scar can result from surgical draining. |
| Silent rupture |
Rupture of a silicone gel-filled
breast implant that happens without a visible change or feel by the
woman and is not evident by a physical examination by the doctor. |
| Silicone |
Silicone is a man-made material that
can be found in several forms such as oil, gel, or rubber
(elastomer). The exact make-up of silicone will be different
depending on its use. See the Device Description section for more
details. |
| Subglandular |
When the implant is placed under and
within the breast glands but on top of the chest muscles. |
| Submuscular |
When the implant is placed underneath
the chest muscles. |
| Transaxillary |
Under the arm. |
