Reconstruction: Breast Implants
Breast Implants
Another form of reconstruction to discuss with your medical team are breast implants. Women with larger breasts could require a combination of a tissue flap reconstruction and an implant. In some cases, your surgeon might recommend an implant for your uninvolved breast to improve symmetry. Your surgeon might also recommend a breast reduction or a breast lift on the uninvolved breast for the same reason. If it is very important to you that your unaffected breast is not altered, you should discuss this with your surgeon as soon as possible, as it may affect the reconstruction methods used in your care.
The breast reconstruction process may begin at the time of your mastectomy (immediate reconstruction), or weeks to years afterwards (delayed reconstruction). Immediate reconstruction may involve placement of a breast implant, but typically involves placement of a tissue expander, which will eventually be replaced with a breast implant. It is important to know that any type of surgical breast reconstruction may take several steps to complete.
Discuss the advantages and disadvantages of the following options with your surgeon and your oncologist:
* Immediate Reconstruction:
One-stage immediate reconstruction with a breast implant (implant only).
Two-stage immediate reconstruction with a tissue expander followed by delayed reconstruction several months later with a breast implant.
* Delayed Reconstruction:
Two-stage delayed reconstruction with a tissue expander followed several months later by replacement with a breast implant.
One-Stage Immediate Breast Implant Reconstruction
In this reconstruction option, the plastic surgeon will insert the breast implant at the time of your mastectomy and after your surgeon removes your breast tissue.
Two-Stage (Immediate or Delayed) Breast Implant Reconstruction
The most common form of reconstruction using implants is a two- stage procedure. Either at the time of the mastectomy or at a later date, a breast tissue expander is placed. Several months later it is replaced with a breast implant.
Tissue Expansion
Generally both skin and breast tissue are removed during a mastectomy, which leaves the chest flat and tight. In order to create a place for the breast implant, a tissue expander is placed under the remaining chest tissue.
A tissue expander is a balloon-like device made from elastic silicone rubber. It is unfilled when inserted, and over time a sterile saline fluid is added using a small needle through the skin to the filling port of the device. As the tissue expander is slowly filled, the tissue over the expander begins to stretch, in a fashion similar to the way a woman's abdomen expands gradually during pregnancy. This expander creates a place for the implant.
The placement of the expander is generally done under a general anesthesia in the operating room and takes one or two hours. You may be required to stay in the hospital briefly, or it may be done on an outpatient basis. Normal daily activity can generally be resumed after two to three weeks.
If your chest skin is numb from the mastectomy surgery, you might not feel any pain from the placement of the expander. You may, however, feel pressure or discomfort after each filling, but this subsides as the tissue expands. The tissue expansion period typically lasts four to six months.
After the tissue expander is removed, the breast implant is placed in the pocket. The surgery to replace the tissue expander with a breast implant (implant exchange) is usually done under general anesthesia in an operating room. It may require a brief hospital stay or be done on an outpatient basis.
Silcone vs. Saline implants
Status of Silicone Gel-Filled Breast Implants
On April 10, 1991, FDA asked the manufacturers to submit evidence in a premarket approval (PMA) application that silicone gel-filled breast implants were safe and effective. However, they were unable to provide FDA with this information. Without enough data on safety and effectiveness, FDA determined that silicone gel-filled breast implants could not be approved. Therefore, silicone gel-filled breast implants were removed from the open market. However, silicone gel-filled implants are available to women through the following FDA-approved studies:
an adjunct study
an investigational device exemptions (IDE) study
An adjunct study is a study developed for continued availability of silicone-gel breast implants for a public health need. In April 1992, after a careful evaluation of the public health need, the alternatives to silicone gel-filled breast implants, and the risks, FDA concluded that silicone gel-filled breast implants should continue to be available for women seeking breast reconstruction or revision of an existing breast implant. Accordingly, the adjunct study was developed to make silicone gel-filled breast implants available for reconstruction and revision patients and to collect short-term complication data. Eligible women include those who have had breast cancer surgery, a severe
injury to the breast, a birth defect that affects the breast, or a medical condition causing a severe breast abnormality. Additionally, those who need to have an existing implant replaced for medical reasons, such as rupture of the implant, are also eligible. Women who want silicone gel-filled implants for breast augmentation (cosmetic reasons) cannot be enrolled in the adjunct studies. According to the adjunct study protocols, each woman will be followed for at least five years.
An IDE study is a clinical study that must be reviewed and approved by FDA to help assure that the resulting data will be meaningful and that patients will not be exposed to unreasonable risks. Under the law, FDA cannot acknowledge the existence of any study conducted under the IDE unless the manufacturer publicly announces the existence of the study. Likewise, FDA cannot release the results of studies conducted under an IDE unless the manufacturer has made the data publicly available. Generally, these IDE study data are used as the basis for a future application to market the device. Women participating in an IDE study would receive their implants for the uses described in the study protocol/plan. Each woman who participates in an IDE study must give informed consent, and an Institutional Review Board (IRB) must oversee the study. An IRB is composed of scientists, health professionals, and community members who do not have a bias as to the outcome of the study.
To date, both Mentor Corporation and McGhan Medical have adjunct and IDE studies approved by FDA. For further information on enrolling into one of these studies,
contact your doctor or the manufacturer.
Status of Saline-Filled Breast Implants
The manufacturers of saline-filled breast implants were notified by FDA in January 1993 that the agency would require data on their products' safety and effectiveness. While the manufacturers were conducting the required studies, saline-filled breast implants remained on the market.
On August 19, 1999, FDA asked the manufacturers to submit evidence in a PMA that saline-filled breast implants were safe and effective. On March 1-3, 2000, FDA's
General and Plastic Surgery Devices Panel met to review PMAs for saline-filled breast implants manufactured by Mentor Corporation, McGhan Medical, and Poly Implant Protheses (PIP). The Panel voted to recommend approval of Mentor Corporation and McGhan Medical's saline-filled breast implants and to recommend disapproval of PIP's implants. On May 10, 2000, FDA granted approval of Mentor's and McGhan's PMAs.
To date, all other manufacturers' saline-filled breast implants are considered investigational.
If you want to receive an implant other than Mentor and McGhan's, you must enroll in an IDE study. To enroll in an IDE, contact your doctor or the manufacturer.
