PROCEDURES OF THE BREAST: REMOVAL OF SILICONE GEL-FILLED BREAST IMPLANTS AND CAPSULECTOMIES

ASPS BRIEFING PAPER

Procedure Status

Due to public concern about the perceived health risks of silicone-gel breast implants, a number of women continue to seek implant-removal surgery. When a woman decides to have her silicone-gel implants surgically removed or replaced with saline-filled implants, she may also opt for removal of the scar tissue barrier or "capsule" that naturally forms around the implants when they are inserted. This procedure is called a capsulectomy.

Position statement: The American Society of Plastic Surgeons (ASPS) believes that women should understand the risks and benefits of implant removal and capsulectomy. The most current research available indicates that for most women, removal of the breast implant and the surrounding capsule will have no affect on any systemic disease they may have.

Notable stats: The most recent (1994) nationwide survey of plastic surgeons has revealed the following about implant removal:

· An estimated 37,853 breast-implant removal procedures were performed during the survey year.

· Of that number, 28,655 of the removals were performed on cosmetic augmentation patients and 9,198 were patients who had implants inserted as part of breast reconstruction surgery.

· Seventy four percent of the augmentation patients and 80 percent of the reconstruction patients said they sought removal because of local physical symptoms related to the implant, such as capsular contracture.

· More than half of the women who underwent implant-removal surgery chose to replace them with saline-filled implants (59 percent of the cosmetic augmentation patients and 52 percent of the reconstruction patients).

Patient Profile

The most common implant-removal/capsulectomy patient is a woman in the 19-34 age range who has local physical symptoms that are probably related to the implant, such as scar tissue formation that has become uncomfortably firm. However, there are a number of women who seek implant removal for symptoms that may not be medically linked to the presence of the implants. Also, a small percentage of women seek implant removal out of fear alone, even if they are exhibiting no troubling symptoms whatsoever.

The best candidates for implant removal are women who are experiencing pain, discomfort or deformity related to their breast implants and who understand fully how their appearance may change as a result of the surgery.

Implant removal and capsulectomy are not generally recommended for women whose gel-filled implants are intact and trouble free. The Food and Drug Administration has stated that the risk of removing trouble-free implants is potentially greater than the risk of leaving them in.

Regulations and Warnings

There are no state or federal laws that mandate the training and qualifications of doctors who call themselves medical specialists and perform implant-removal and capsulectomy surgery.

Patients considering these procedures are advised by ASPS to choose a qualified plastic surgeon who has been granted privileges to perform implant-removal surgery at an accredited hospital. Patients may phone 1-800-635-0635 for a list of board-certified surgeons in their area who have experience in performing implant removal.

Limitations, Risks and Complications

Limitations: If the implant shell has been damaged or ruptured, it may be impossible to remove all the escaped gel from the surrounding tissues, especially if the surrounding scar capsule, which usually contains the leaked gel, has also been injured or damaged.

It is not possible to predict with certainty how a woman will look after implant-removal surgery. Much depends on the nature of the scar capsule and whether the implant has ruptured.

Risks and complications: Even if every effort is made to place incisions in inconspicuous areas, the implant-removal procedure may leave a longer scar than that which resulted from the original implant-placement procedure. Breast sensation may be diminished or altered.

Silicone gel that leaks from an implant and is retained in the breast tissue may interfere with cancer detection because it can block X-rays and interfere with mammography. Silicone shadows that are viewed on a mammogram may have to be biopsied (just like benign lumps of any kind) to make sure they do not hide a cancer.

Larger quantities of gel that escape from a ruptured implant and migrate into surrounding tissues may form lumps called "granulomas," which while benign, may be difficult or impossible to remove without causing deformity.

Capsulectomy, in which the scar capsule is removed along with the implant, is generally a more involved operation than simple implant removal. The surgery usually takes longer, may be more expensive and more often requires general anesthesia.

On the other hand, simple implant removal without capsulectomy may leave scar tissue behind which may be detectable by touch, mammography or other imaging studies.

Patients should be aware that to date, there is no convincing scientific evidence that the gel contained in silicone-filled implants is harmful or toxic. Studies involving millions of women have produced no evidence that links gel-filled implants to any known autoimmune disease or cancer.

Recovery

Most patients are up and around within a day or two and back to work and light activity within one week. Gauze dressings that may have been applied will be removed at the surgeon's discretion. Likewise stitches will be removed when the physician deems it appropriate.

Patients who had replacement implants may be required to wear a surgical bra while the stitches heal.

Some bruising and swelling may persist for three or four weeks. This document is designed to provide accurate and authoritative information in regard to the subject matter covered as of the date of publication and is subject to change as scientific knowledge and technology advances and as practice patterns evolve. The views expressed herein represent the collective, but not necessarily the individual, views of the members of the American Society of Plastic Surgeons.