Are Silicone Breast Implants Safe?


The popularity of breast augmentation with saline or silicone breast implants continues to rise and remains the most requested cosmetic surgery procedure in the United States and abroad.  Either one of two types of breast implants are used by plastic surgeons for augmentation procedures and for reconstruction after a mastectomy (breast removal) as part of breast cancer treatment.

Types of Breast Implants

Breast implants are silicone shell filled with either saltwater or silicone gel.  These shells are surgically placed between the layers of muscle in a woman’s breast area to replace or augment the breast mound for cosmetic breast augmentation or reconstruction.

Saline breast implants and silicone breast implants each have their own look, and are recommended for different reasons.

Saline Breast Implants

Saline-filled breast implants consist of a silicone shell filled with a sterile saltwater (saline) solution. Depending on the particular woman and her situation, the saline implant could be pre-filled or might be filled during the implant operation. Most are filled during the operation. Saline-filled implants come in different sizes and have either smooth or textured shells. The FDA has approved saline-filled breast implants for breast reconstruction in women of any age and for breast augmentation in women age 18 or older. Saline implants can also be used in revision surgeries done to correct or improve the result of another surgery.

silicone breast implants before after photo
Breast augmentation with silicone breast implants

Silicone Breast Implants

As opposed to implants containing a saline solution, silicone breast implants are filled with silicone gel — a thick, sticky gel that closely mimics the feel of human fat. Most women feel that silicone breast implants look and feel more like natural breast tissue. These implants are less likely to ripple or be palpable when compared to saline breast implants.

Silicone breast implants are available to women 22 and older for breast augmentation and to women of any age for breast reconstruction.

Your surgeon will have available to him three kinds of silicone breast implants:

A pre-filled shell containing silicone, not expandable after surgery. These are the most commonly used silicone breast implants.

A two-layered shell with an inner shell pre-filled with silicone, and an outer shell that is filled with saline during surgery. This type is also not expandable after surgery.

A two-layered shell, one inner shell pre-filled with silicone, and one outer shell that is filled with saline during surgery. The outer shell contains a valve through which more saline can be added after surgery.  This type of implant is expandable after surgery.  However, these expandable silicone breast implants are not commonly used.

Are Silicone Implants Safe?

In 1992, after a tumultuous history of lawsuits and concerns over risks to health and safety, the FDA banned the use of silicone implants for cosmetic purposes.  However, during the ban, silicone breast implants were still used in post mastectomy breast reconstruction.

Fourteen years later, when links to health risks failed to be confirmed, the FDA lifted the ban on silicone implants and proclaimed them to be “safe and effective.”

Today silicone gel-filled breast implants are approved for increasing breast size (breast augmentation) in women age 22 or older and for breast reconstruction (after cancer surgery or other medical issues) in all women. The FDA has also approved silicone implants for revision surgeries used to correct or improve the results of a previous reconstruction or augmentation surgery.

The FDA continues to support the safety and effectiveness of silicone gel implants.  This governing body also advises women to fully understand the risks associated with these and other types of implants and the need to have them checked and monitored on a regular basis.

Women receiving breast implants, for cosmetic or reconstructive reasons, should understand these are not lifetime devices.  The longer they stay in place, the greater the need for monitoring.  Implants will need to be removed or replaced if they begin to leak.

Long term monitoring of breast implants is essential.

How can you tell if a silicone breast implant is leaking?

In the unlikely event that a silicone implant tears or leaks between exams it could cause breast pain or changes in the size, contour or shape of the affected breast.  The good news is that the FDA does not believe that a ruptured silicone implant could cause any sort of systemic (of or relating to the whole body) disease.  They are safe.

When silicone breast implants are placed in your body, fibrous tissue, called a capsule forms, around the implants and contains them. This is a normal part of healing. If the implant ruptures, it might go unnoticed because any free silicone tends to remain trapped within this capsule. This is one reason it’s important to get regular checks-ups.  The best way to detect a leak in silicone breast implants is to get an MRI scan. The current recommendation is to get an MRI after your third year and then every other year after that.

silicone breast implants before after pic
Cosmetic breast augmentation with silicone breast implants

Gummy Bear Implants

In 2013, the FDA approved the Gummy Bear Breast Implant.  Stronger and more durable than previous silicone implants, Gummy Bear implants are filled with a semi-solid, highly cohesive silicone gel, surrounded by a thick, strong, multi-layered outer silicone shell.

The most significant difference between these implants and traditional silicone gel breast implants is the thick consistency of the filler material, which remains intact and retains its shape, even when cut (like a gummy bear candy).

Gummy Bear Implants are a type of form-stable breast implant.  They are a tear drop shape that needs to stay in a proper orientation to appear natural. Among the advantages of these implants is the stiffer silicone gel they contain.  It is less prone to wrinkling after implantation than saline implants. The implant’s textured surface is intended to prevent hardening scar tissue and hold the implant in place so it doesn’t rotate.

These silicone breast implants involve no risk of leakage if the shell around the implant ruptures. The gel’s cohesive consistency keeps it from spilling or running into the body.

Like other implants, the new Gummy Bear breast implants must be monitored and are not considered lifetime devices.

Are You a Good Candidate for Silicone Breast Implants?

The choice of implants for breast augmentation depends on a variety of factors.

Use of silicone breast implants for cosmetic augmentations are approved for women over 22 years old or for breast reconstruction. They are not approved for those under the age of 22 for cosmetic breast augmentation.

Saline implants are approved for any woman over the age of 18 for cosmetic breast augmentation.

A silicone implant has a softer, more natural feel.

Saline implants tend to look more rounded and are more visible in the upper portion of the breast, which is not the way a natural breast looks. Silicone may offer a more normal slope to the upper breast.  Also, the rippling that can be an issue with saline is less likely with silicone. Rippling is especially problematic for very thin women. Silicone breast implants may be a thin woman’s best alternative.

Both saline and silicone are safe as long as you understand and comply with the need to have them monitored, and always follow-up with your plastic surgeon for appropriate checkups.

Breast Implant Consultation

If you are thinking of getting a cosmetic breast augmentation, Dr. Ganchi will be glad to discuss the various breast implant options with you and help you decide on what’s best for your unique situation. The best breast augmentation results are achieved by the most experienced top plastic surgeons.