Silicone Breast Implants -- Fact Sheet

Choosing whether you want saline-filled breast implants or silicone-filled breast implants is one the major decisions you will have to make when planning your breast augmentation. Silicone implants have a durable, elastic silicone shell filled with silicone gel that mimics the feel of natural breast tissue. They come in round and teardrop (anatomical) shape, and in both smooth and textured shell surfaces.

Who Is Best Suited for Silicone Implants?

Because silicone implants have less rippling than saline implants and are softer to the touch, some doctors recommend them for slender women with less fat and body tissue to hide the implant. However, almost any woman can consider silicone breast implants for their body.

What Are the Benefits of Silicone-Filled Breast Implants?

Here are some additional benefits of silicone breast implants.

  • Each implant has a set volume that will give you predictable results
  • The silicone gel is naturally pliable and resembles the natural breast tissue
  • If it ruptures or leaks, the silicone gel is not released into the body

Watch a video that tests the durability of silicone gel breast implants.

What Are Some of the Negative Aspects of Silicone-Filled Breast Implants?

When a breast implant ruptures, the outer shell of the implant is torn. This can be caused from physical trauma, capsular contracture, or complications from other medical procedures. But unlike a saline implant that physically changes when ruptured so you notice it, silicone implants don’t have any physical markers of being torn--it’s known among doctors and patients as a silent rupture. This makes it much more difficult to notice a rupture in a silicone implant than a saline. However, because of the durability of modern implants, rupturing is extremely rare.

About Silicone Gel

Silicon is the second most abundant element on earth, next to oxygen. Silicones are actually a family of chemical compounds. The main compound is silicon, a naturally occurring element found in sand, quartz and rock. When silicon is mixed with oxygen, hydrogen and carbon, it becomes silicone. Silicone can be made in a variety of forms. Low molecular weight silicones form oils, middle molecular weight silicones form gels, and high molecular weight silicones form elastomers and rubbers. Silicone is found in many other types of implants, such as facial implants, artificial joints, drainage systems, etc.

Currently, Mentor and Inamed silicone implants have three layers of shell surrounding the silicone gel. This reduces the amount of gel bleed. It does, however, make the implants a bit firmer than they were years ago, but this is attributed to the thicker shell. Many people find the silicone implants of today soft and natural-feeling.

Silicone gel breast implants come pre-filled, meaning that there is no fill to be added. The only real drawback to a pre-filled implant is that the incision will have to be a bit longer, depending on the size of the implant. This is especially true for textured silicone and gummy bear silicone implants, which are somewhat firmer. Another reason that textured silicone implants require a longer incision is the fact that the shell is textured. Because silicone gel breast implants come pre-filled, they cannot be inserted via the TUBA incision (neither can any other type of pre-filled implant).

Medical Grade Silicone

You may be wondering whether silicone is really that safe to put into your body. The fact is that silicone is used not only in breast implants, but also in implants located literally throughout every part of the body. Among many other applications, it has been used in the following:

  • To construct heart valves and other cardiovascular prostheses
  • To fashion catheters used for purposes from drug delivery to cardiac monitoring
  • As a facilitator for nerve regeneration
  • As a prosthesis or ingredient in prostheses for many parts of the skeletal system
  • As a tissue expander
  • As a cosmetic agent for treatment of scars and wrinkles
  • In the ear, nose, throat and respiratory tract
  • In the urogenital tract, including penile prostheses
  • In the gastrointestinal tract
  • In ophthalmology
  • In dentistry

What Is the History of Silicone Breast Implants with the FDA?

On November 17, 2006, the FDA approved silicone gel implants. Now that the products have been determined to be safe and effective, the FDA will continue to monitor them by requiring each breast implant manufacturer to conduct a large post-approval study that will follow about 40,000 women for 10 years after receiving breast implants. The FDA often requires post-market studies to answer important questions that can only be answered once a product is in broader use, such as the incidence of rare adverse events.

The FDA's decision to approve these implants was based on a few things:

  • A thorough review of each company's (core) clinical and pre-clinical studies
  • A review of studies by independent scientific bodies
  • Deliberations from advisory panels of outside experts that heard public comment from hundreds of stakeholders

In addition, the FDA conducted inspections of each company's manufacturing facilities to determine that they comply with the FDA's Good Manufacturing Practices. Some of the complications reported in the core studies of silicone implants include hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery. However, the majority of women in these studies reported satisfaction with their implants.

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 farther in the post-approval studies conducted by the companies.

Becker Expandables

It's important to know the difference between the Becker Expandable and the Spectrum Expandable breast implant. Dr. Hilton Becker, in conjunction with Mentor Corp., designed the Becker Expandable in 1984. There are two types of Becker Expandable implants available: the Classic Becker and the Becker 50.

The Classic Becker has 75 percent saline in the inner lumen and 25 percent gel in the outer lumen for a soft touch and less rippling under thin tissues. It’s mainly a reconstructive device and can be used as a tissue expander, as well as a long-term implant. The Becker 50 has 50 percent saline in the inner lumen and 50 percent gel in the outer lumen. The saline is for expansion and fluid volume adjustment.

The Becker Expandable was the first permanent tissue expander designed specifically for reconstructive purposes. In the late 1980s, this implant/expander found its way into general breast augmentation. However, after the FDA imposed the moratorium on silicone gel breast implants, the use of the Becker Expandable was restricted, but was replaced with the Spectrum Expandable implant. Becker Expandables are still in use, but due to cost ($2,000 - $2,200 per implant), they're really not suitable for general breast enlargement.

Updated August 2016

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