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.

Uneven appearance between a woman's breasts in terms of size, shape, or breast level.

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.

Pain in the nipple or breast area. See the Local Complications & Reoperations section for more details.

A pocket surgically created to hold the implant.

Thinning and shrinking of the skin.

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.

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.

When the chest wall or underlying rib cage appears deformed following removal of the implants and breast tissue.

Incision site fails to heal normally or takes longer to heal.

Rupture of silicone gel-filled breast implant in which the silicone gel is outside of the fibrous scar capsule that forms around the implant.

Skin breakdown with the implant appearing through the skin.

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.

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.

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.

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).

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.

Within the breast fold.

Swelling of the breast area, usually with redness.

Rupture of silicone gel-filled breast implant in which the silicone gel remains contained within the fibrous capsule.

Not approved, in general terms. For breast implants, this means not PMA-approved.

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.

Complications that occur in the breast or chest area.

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.

Partial or complete removal of the breast.

Surgical procedure to raise and reshape sagging breasts. Women may also have this surgery after an implant is removed and not replaced.

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.

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 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.

Around the nipple.

Application for marketing a device. FDA must approve the PMA for the device to be sold on the market in the U.S.

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.

Sagging/drooping of the breast.

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.

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.

Surgical procedure to reduce breast size.

Removal of the implant, with or without replacement. See the Local Complications & Reoperations section for more details.

Any additional surgery performed to the breast or chest area. See the Local Complications & Reoperations section for more details.

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.

This is replacement of an existing breast implant. Revision is one of three indications (clinical uses) for breast implants.

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.

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.

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.

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 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.

When the implant is placed under and within the breast glands but on top of the chest muscles.

When the implant is placed underneath the chest muscles.

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.

Under the arm.

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

Wrinkling of the implant that can be felt or seen through the skin.

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.