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. |
Asymmetry |
Uneven appearance
between a woman's breasts in terms of size, shape, or breast level. |
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 pain |
Pain in the nipple
or breast area. See the Local Complications
& Reoperations section for more details. |
Breast pocket |
A pocket surgically
created to hold the implant. |
Breast tissue atrophy |
Thinning and
shrinking of the skin. |
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. |
Capsular contracture |
Scar tissue or
capsule that normally forms around the implant, which tightens or squeezes
the implant. There are four grades of capsular contracture ranging from
grade I (breast is normally soft and looks natural) to grade IV (breast
is hard, painful, and looks abnormal). See the Local
Complications & Reoperations section for more details. |
Chest wall deformity |
When the chest
wall or underlying rib cage appears deformed following removal of the
implants and breast tissue. |
Delayed wound healing |
Incision site
fails to heal normally or takes longer to heal. |
Extracapsular rupture |
Rupture of silicone
gel-filled breast implant in which the silicone gel is outside of the
fibrous scar capsule that forms around the implant. |
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. |
Granuloma |
Non-cancerous
lumps that can form when certain body cells surround foreign material,
such as silicone. Like any lump, it should be evaluated to distinguish
it from a lump that might be cancerous. |
Hematoma |
Collection of
blood inside a body cavity. Swelling, pain, and bruising may result.
If a hematoma 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 hematomas, large ones may require the placement of surgical
drains for proper healing. A small scar can result from surgical draining.
|
Iatrogenic injury/damage |
Injury/damage
to the tissue or implant due to surgical instruments either during the
operation, during a reoperation, during implant removal, or during breast
procedures while the implant is in place (e.g., cyst aspiration or hematoma
drainage). |
Infection |
Can occur with
any surgery when wounds are contaminated with micro-organisms such as
bacteria or fungi. Most infections resulting from surgery appear within
a few days to weeks after the operation. However, infection is possible
at any time after surgery. Infections with an implant present are harder
to treat than infections in normal body tissues. If an infection does
not respond to antibiotics, the implant may have to be removed. Another
implant may be placed after the infection is gone. |
Inframammary |
Within the breast
fold. |
Inflammation/ irritation |
Swelling of the
breast area, usually with redness. |
Intracapsular rupture |
Rupture of silicone
gel-filled breast implant in which the silicone gel remains contained
within the fibrous capsule. |
Investigational |
Not approved,
in general terms. For breast implants, this means not PMA-approved. |
Investigational Device Exemption (IDE) |
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 a device in an IDE study
is investigational. |
Local complications |
Complications
that occur in the breast or chest area. |
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. |
Nipple/breast sensation changes |
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. See the Local
Complications & Reoperations section for more details. |
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. |
Prospective study |
Study in which
people are exposed to a medical intervention, such as breast implants,
and then observed over time to determine how effective and safe the intervention
is. The outcome is not known when a prospective study is started. Medical
evaluations are performed before and after the intervention so that the
outcome of the intervention can be measured. |
Ptosis |
Sagging/drooping
of the breast. |
Reconstruction |
Includes non-cosmetic
uses such as post-mastectomy, a severe injury to the breast, a birth defect
that affects the breast, or a medical condition causing a severe breast
abnormality. Reconstruction is one of three indications (clinical uses)
for breast implants. |
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. |
Reduction mammoplasty |
Surgical procedure
to reduce breast size. |
Removal |
Removal of the
implant, with or without replacement. See the Local
Complications & Reoperations section for more details. |
Reoperation |
Any additional
surgery performed to the breast or chest area. See the Local
Complications & Reoperations section for more details. |
Retrospective study |
Study that begins
after a medical intervention, such as breast implant surgery, has occurred.
Therefore, it looks backward in time at events complications that happened
in the past. For instance, a group of women with breast implants may
be identified and then asked to allow researchers to review their medical
records to obtain information on complications that they had. Women might
also be asked to respond to a survey or interview about whether or not
they had complications with their implants. The problem with this type
of study is that it assumes that if there was a problem, it would be in
the medical record or that someone would remember it accurately. |
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. |
Scarring |
Formation of
tissue at the incision. All wounds heal by the formation of a scar. The
degree of scarring varies from person to person, and skin type is an important
factor for the development of scars. If the scarring becomes irregular
and raised, it is called hypertrophic scarring. This may leave a visible,
permanent scar. The keloid, a severe type of hypertrophic scar, generally
does not fade or flatten with time. |
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. |
Toxic Shock Syndrome |
Rare, but life-threatening
bacterial infection that may occur after surgery. Symptoms include sudden
fever, vomiting, diarrhea, fainting, dizziness, and sunburn-like rash.
A doctor should be seen immediately for diagnosis and treatment if
toxic shock syndrome is suspected. |
Transaxillary |
Under the arm.
|
Unsatisfactory style/size |
Patient or doctor
is not satisfied with the overall look based on the style or size of implant
used. |
Wrinkling/ rippling |
Wrinkling of
the implant that can be felt or seen through the skin. |
510(k) |
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. |