Breast Implant
Size & Shape Options
Before getting breast implants, you must consider your size and shape options. Only you and your surgeon can determine which size and shape combination is best, but you should read about the different choices.![]()
Breast Augmentation
History & the FDA
The FDA only recently approved silicone breast implants. Review a quick history of breast augmentation and get in-depth info on the FDA's decisions.![]()
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Saline or Silicone Breast Implants?
While both saline and silicone breast implants are FDA-approved, each are made in a variety of styles and have different pros and cons. After reviewing the information on this page, you should consult with your surgeon about which option you feel would work best for you.
Silicone breast implants
Silicone breast implants contain a mix of organic and inorganic polymers. They tend to vary in consistency, from liquid to hard plastic. The shells of the implants are silicone rubber and have a patch to cover the manufacturing port.
These breast implants can be either smooth or textured and come in a range of volumes, shapes, profiles and shell thicknesses. Most of them are not adjustable, so if a patient is dissatisfied with the implants, she will have to replace them.
Saline breast implants
There are two types of saline breast implants. The first is fixed-volume, in which the entire intended volume of saline is put in at initial implantation. The other type is adjustable volume, in which the implant can be filled intraoperatively and further adjusted.
Benefits of silicone breast implants:
- The gel has a look and feel similar to that of breast tissue, so it appears more natural
- Since it does look more natural, silicone is more effective for women with smaller breasts
- A new gel called cohesive silicone retains its shape even in cases of rupture. It is still being tested and studied but is increasingly popular in Europe. The FDA has given conditional approval to only a few companies in the U.S. to manufacture this type of implant
Disadvantages of silicone breast implants:
- Ruptured silicone breast implants are not noticeable right away, allowing small amounts of the gel to leak without detection
- The gel can, after rupture, leak into the bloodstream where its effects are not yet well-known, or it can move to other parts of the body, causing visible lumps
- There is speculation that silicone may have a link to cancer, though no concrete evidence exists
Benefits of saline breast implants:
- Saline breast implants vary in volume, shape, expandability, shell thickness and shell surface, making them easier to customize
- They are safer since, if rupture or leakage occurs, the solution will blend easily with the body’s other saline fluids
- Ruptures are easily noticed, as the implant will quickly shrink
- Saline implants require smaller incisions because they can be filled after insertion
Disadvantages of saline breast implants:
- If a rupture does occur, it happens suddenly. This is desirable in the sense that it’s detected right away, but some women feel that this could be a social disadvantage
- The saline solution moves around more than silicone gel, and some patients find it uncomfortable
- Saline breast implants should be replaced after about 7 to 10 years
FDA-Approved Breast Implants
Saline-filled breast implants
The only currently FDA-approved breast implants are made by Mentor and Allergan. Both companies manufacture saline and silicone implants, and both companies offer warranties covering product replacement in the event of a deflation or some of the expenses from the resulting revision surgery.
Mentor’s saline-filled high profile breast implants
Also known as the Mentor 3000 implants, these are the same as regular saline breast implants but seem to have less rippling, more projection for the same size and less lateral base. This is a good choice for women with smaller chest diameters, as it provides greater projection than stand
ard saline implants.
Saline-filled expandable breast implants
Originally designed for Mentor by Dr. Hilton Becker in 1984, this implant is most commonly used in cases of breast reconstruction, as it gradually expands the breast tissues without causing severe trauma. In the late 1990s the Becker expandable was replaced by the Spectrum implant (sometimes called the Spectrum-Becker). The original Becker saline-expandable implant is still available, but it is highly restricted by the FDA.
The Spectrum, like standard breast implants, comes in different sizes and cannot be inflated indefinitely. You must have a general idea of how large you would like to be post-operatively, then build on this size. Spectrum implants, too, can be either smooth or textured and can be placed either sub-glandularly or sub-pectorally.
Silicone gel-filled breast implants
After years of study, the FDA approved Mentor and Allergan silicone breast implants in 2006 for women 22 years and older. Silicone breast implants have long been controversial for their supposed link to cancer, though no studies have definitively proven this link.
Breast Implants Currently Awaiting FDA Approval and/or Additional Testing
Cohesive silicone gel breast implants
Referred to as the “gummy bear," this type of silicone implant has been in use since 1995 and is available in France. Cohesive gel has a much thicker consistency than regular gel, making it far less likely to leak in cases of rupture. The cohesive gel implant is currently in clinical trials in the U.S. and is an approved medical device in Australia.
Hydrogel-filled breast implants
These breast implants consist of a silicone elastomer shell filled with either a biologically inert hyaluronic acid fluid, a polysacharide gel or a hydrophilic polycrylamide gel. The hyaluronic filler is the same substance as Restylane, an injectable filler used on lips and wrinkles. As of now, these implants have been denied approval and additional clinical trial time because of a lack of long-term studies.
Breast Implants Available Only Outside of the U.S.
Poly implant prosthesis hydrogel breast implants
Manufactured in France and distributed by Clover Leaf Products Ltd., the PIP is pre-filled with a hydroxypropyl cellulose hydrogel filler. This implant was voluntarily recalled due to a request from the MDA (The UK’s Medical Device Agency) for more studies "due to the lack of long-term toxicity data or clinical follow-up, together with methodological flaws in some of the pre-clinical tests."
Poly implant prosthesis saline breast implants
This type of implant, also manufactured in France and similar to the standard saline implant, was denied FDA approval so far because the manufacturer couldn’t provide sufficient studies on their safety. The company has since reapplied for approval in the U.S.
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