American society of plastic surgeons - Member

Saline and Silicone Breast Implants

Breast implants have a wide range of uses extending from restoring a breast removed after mastectomy to helping women with asymmetrical (different) breast sizes.

Following pregnancy, or with weight loss, many women opt for breast implant surgery to correct reductions in breast volume while others are simply interested in creating a more flattering contour.

Since 1992, silicone gel-filled implants have been available only to breast reconstruction patients and patients undergoing breast revision surgery. In order to receive silicone, women had to be enrolled in clinical trials.

On November 17, 2006, U.S. Food & Drug Administration (FDA) ended a 14-year ban on the use of silicone implants for cosmetic breast surgery and announced the approval and availability of silicone gel-filled breast implants. Now all women over 22 years old seeking cosmetic breast augmentation and women seeking breast reconstruction surgery will be able to select silicone breast implants. The availability of silicone gel implants will create new options for women considering breast surgery for the first time and for those who have had previous surgeries but are seeking new replacements or revision.

The outer shell of both silicone and saline implants is made of a solid silicone material. Solid silicone is widely used in implantable medical devices. The filler material, however, differs; silicone gel implants are filled with silicone gel, which is a semi-solid, while Saline-filled implants are filled with the same kind of salt water that is used in I.V. fluids. An important question, therefore, is if an implant will eventually rupture, what is the effect of the filler material on the body when it does leak?

Silicone Implants

Silicone implants have a silicone rubber shell that is filled with a fixed amount of silicone gel. Silicone implants come in smooth or textured shell surface and vary in shape, profile, volume, shell thickness, and number of shell lumens. Most silicone gel-filled implants are not adjustable which is one disadvantage compared to saline implants.

In 1999, a landmark report, undertaken by the Institute of Medicine (IOM) concluded that silicone implants do not cause major health problems such lupus or rheumatoid arthritis. And while no one can ignore the fact that silicone – and saline – breast implants may cause localized problems for some patients, numerous scientific studies over the years have shown that silicone gel-filled implants are both safe and effective for breast augmentation and breast reconstruction. In fact, silicone gel breast implants are widely used in 60 countries around the world including Europe, and now are available for use in the U.S. market.

In the past decade, a number of independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer. The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases. However, these issues will be addressed further in the post-approval studies conducted by Mentor Corporation and Allergan (manufacturers of FDA-approved silicone gel breast implants).

Saline Implants

Offering an alternative to silicone, manufacturers chose saline as an implant filler. Saline implants also have a silicone outer shell (the same shell used in silicone gel-filled implants) and contain salt water.

Saline implants, which were officially approved by the FDA in 2000, have some advantages and disadvantages over silicone breast implants:

All implants carry a risk of rupture. If a saline implant leaks or breaks inside a woman’s body, the salt water is simply absorbed into her tissue.

The size of silicone implants cannot be changed without actually changing the implant with an operation.

Some patients may find that saline implants do not offer a natural look and feel and that silicone mimics this more effectively. Indeed, many surgeons and patients with breast implants have the opinion that silicone implants have a more natural look and feel than saline implants due to the fact that silicone gel has a texture similar to breast tissue.

Saline implants carry many of the same risks as silicone gel-filled implants, including capsular contracture, infection, pain, and nerve damage. Implants, whether filled with saline or silicone, are not lifetime devices and may need to be replaced.

Silicone implant ruptures are harder to detect. When saline implants rupture, they deflate and the results are usually seen almost immediately. When silicone implants rupture, the breast often looks and feels the same because the silicone gel may leak into surrounding areas of the breast without a visible difference.

What is in the future for breast Implants?

Silicone gel remains a potentially popular implant choice primarily because it produces a natural-feeling breast and is particularly effective for women with minimal breast tissue. Recently, however, a new formulation of silicone gel, which is thicker than previous gels and retains its shape even in the event of a tear or rupture of the implant shell, has been developed and is undergoing clinical trials. Called “hyper-cohesive” or “cohesive silicone gel,” this new filler innovation has already been used extensively outside the United States, and is currently undergoing investigation – eventual FDA approval is anticipated.

Credentials – Is there a difference?

YES – ABSOLUTELY!!! Breast augmentation is a procedure which, unfortunately, can be performed by any physician – whether adequately trained or not. Most states have very little regulation on this matter. Because of this, non-plastic – or so called “cosmetic” – surgeons can perform breast augmentation as well. In addition, some physicians who are legitimately board certified in other specialties, such as ENT, dermatology, and gynecology, for example are performing “cosmetic” surgery even though they often have never had any formal residency training in the specialty of plastic surgery itself. Weekend courses abound and the patient is often confused as to which doctor to see.

Considering breast augmentation is usually a well thought out process – we strive to ensure that all your questions are fully answered.

Hospital Affiliation

Again, yes. Although operating in an office setting is not in and of itself inappropriate, it is always possible that an extended hospital observation or additional care might be needed. Indeed, certain procedures or multiple surgeries are usually best treated within the context of a full hospital facility. In addition, hospitals usually require certain standards (credentialing) such as board certification before a physician can have staff privileges. Unfortunately, there are no legal restrictions in most states that prevent physicians operating out of their offices or non hospital associated free-standing surgery suites; so be sure to ask if your doctor does have admitting privileges at a fully accredited hospital facility. If they don’t, their ability to either transfer patients or provide continuity of care is potentially compromised.

Helpful hints

Needless to say, your decision in choosing a plastic surgeon can be a difficult and time consuming task making it even more important that you personally visit with the plastic surgeon that will perform your procedures. Evaluate their results (photos), office, staff, and testimonials and your feelings regarding your overall experience with their practice. You can often ask to speak to other patients who are willing to share their experiences with you.

Schedule a consultation

Considering breast augmentation is usually a well thought out process and, at Image by Design Plastic Surgery, we strive to ensure that all your questions are fully answered.

Additional Resources:
Breast Augmentation
Candidates For Surgery
Breast Implants
Breast Lift

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