Breast Implant, Breast Enlargment, Breast Augentation Information

The following information is from the American Society of Plastic Surgeons and no copyright is claimed by TheNeighborhoodDoctor.com

May 11, 2000

ARLINGTON HEIGHTS, Ill - The two largest organizations of board-certified plastic surgeons welcome today’s ruling by the Food and Drug Administration (FDA) regarding the safety and efficacy of saline-filled breast implants. The FDA ruled that saline-filled breast implants made by both Mentor Corporation and McGhan Medical Corporation may continue to be marketed, and that information on the risks should be made available to women so they can make informed decisions.

"Today there is ample scientific evidence supporting the safety of saline-filled breast implants," said C. Lin Puckett, MD, president of the American Society of Plastic Surgeons (ASPS). "Women must be fully informed of the potential risks and benefits of implants and should have the right to choose. This ruling provides that option."

"Studies have shown that the vast majority of patients with saline-filled breast implants would make the same choice again," says Fritz E. Barton, Jr., MD, president of the American Society for Aesthetic Plastic Surgery (ASAPS). "The high satisfaction rate, and the determination of so many women to undergo a surgery with the knowledge that it is not a perfect operation, suggests just how deeply the benefits are felt."

The saline breast implants were approved for breast augmentation in women 18 years or older and for breast reconstruction.

Saline-filled breast implants have been available since the late 1960s. Like most medical devices, they have evolved in both design and production. Today’s ruling marks the end of a regulatory process that began in the 1980s, when the FDA categorized saline-filled breast implants as Class III devices, requiring the highest level of premarket review.

In March, 2000, the FDA’s General and Plastic Surgery Advisory Panel held hearings to determine whether current safety and efficacy data for saline implants met the agency’s requirements for approval. The FDA’s regulatory process calls for the agency to evaluate medical devices on a product-specific basis, manufacturer by manufacturer. The panel found no evidence that the saline-filled implants cause major diseases, and recommended approval for devices manufactured by Mentor and McGhan.

ASPS is the largest organization of board-certified plastic surgeons in the world. ASAPS is the leading organization of board-certified plastic surgeons who specialize in cosmetic surgery. Members of both organizations are certified by the American Board of Plastic Surgery.

Informed decision-making documents by Mentor Corporation and McGhan Medical Corporation are located on the FDA web site.

If you're considering breast augmentation...
Breast augmentation, technically known as augmentation mammoplasty, is a surgical procedure to enhance the size and shape of a woman's breast for a number of reasons:

To enhance the body contour of a woman who, for personal reasons, feels her breast size is too small.

To correct a reduction in breast volume after pregnancy.

To balance a difference in breast size.

As a reconstructive technique following breast surgery.

Implants are surgically place behind each breast, increasing a woman's bustline or correcting a cosmetic asymetry that often occurs from breast feeding. If you're considering breast augmentation, it is important that you make an educated decision. In addition to the following, please ask your surgeon if there is anything you need clarified about the proceedure.

Before you decide to have surgery, think carefully about your expectations and discuss them with your surgeon.

The best candidates for breast augmentation are women that aren't expecting a perfect breast enhancement, but desire an improvement in the way their breast look. If you're healthy and have realistic expectations, you may be a good candidate for breast augmentation surgery.

Types of Implants

Silicone shell filled with either silicone gel or a salt-water solution known as saline.

The Food & Drug Administration (FDA) has determined that new gel-filled implants, should be available only to women participating in approved studies, due to the concern over the safety of silicone leakage. Some women, that have silicone filled implants requiring replacement may also be eligible to participate in the study.

Saline-filled implants

There are risks associated with surgery and specific complications associated with this procedure.

The most common problem, capsular contracture. This is a tightening of scar tissue.
Excessive bleeding following the operation may cause some swelling and pain.
Infection around an implant can occur, however this is a rare occurence.
Women that have have augmentation surgery report that their nipples become undersensitive, oversensitive, or even numb. These symptoms usually disappear within time, but may be permanent in some patients.

Breast implants may break or leak. This can occur from direct trauma or strenuous movements. If a saline-filled implant breaks, the implant will deflate, and the salt water will be harmlessly absorbed by the body.

In a gel-filled implant one of two things may occur. Silicone gel may move into surrounding tissue. The gel may collect in the breast and a new scar to form, or the gel may absorb and move to another area of the body. There may be a change in the shape or firmness of the breast. Breaks may require a second operation and replacement. Sometimes, the surgeon not be able to remove all of the silicone gel in the breast tissue if a rupture should occur.

A few women with breast implants have reported symptoms similar to diseases of the immune system, such as scleroderma and other arthritis-like conditions. These symptoms may include joint pain or swelling, fever, fatigue, or breast pain. Scientist have found clear link between silicone breast implants and the symptoms of what doctors refer to as "connective-tissue disorders," but the FDA has requested further study.

Scheduling regular examinations by your plastic surgeon having regularly schedule mammograms for those in the appropriate age groups, will help in detecting any problems that can occur early so that they may be treated in a expediently.

To learn more about breast implants

FDA Information