Saline Breast Implants

What is are Saline Breast Implants?
The three types of saline-filled breast implants are as follows:

One type is a single lumen implant that is filled during the operation with a fixed volume of saline through a valve. There are no adjustments of the saline volume after the operation.

A second type is a single lumen implant that is filled during the operation with saline through a valve. This type of implant allows for adjustments of the saline volume after the operation.

A third type is a single lumen implant that is prefilled by the manufacturer with a fixed volume of saline. There are no valves for filling during the operation or for adjustments of the saline volume after the operation.

The silicone rubber shell for a saline-filled breast implant has the following general composition:

cured polymeric (large) silicones
approximately 20% of finely powdered silica that is tightly bound to the silicone polymers
small amounts of smaller silicones
minute amounts (parts per million) of metals, including a metal catalyst (usually tin, zinc, or platinum) (A catalyst is something that causes a change in material.)
traces of readily evaporating materials (volatiles), such as xylene and other organic compounds.
The filler is sterile saline that should conform to United States Pharmacopeia (USP) standards for Normal Physiological Saline (injection grade). 2

Prior to August 1999, saline-filled breast implants were sold on the market either as preamendments devices (they were on the market prior to May 1976) or as 510(k)-cleared devices. In August 1999, FDA issued a regulation that required that all saline-filled breast implants be PMA-approved to be sold on the market. However, those companies that had a preamendments or 510(k)-cleared saline-filled breast implant and submitted their PMA within 90 days of the August 1999 regulation were allowed to keep their device on the market until the final decision/actions were made in May 2000. Since May 2000, a saline-filled breast implant must be PMA-approved to be sold on the market.3

On May 10, 2000, FDA approved Mentor Corporation’s and Inamed Corporation’s (formerly McGhan Medical) saline-filled breast implant PMAs. As of the date of this handbook, these are the only two companies with PMA-approved saline-filled breast implants.

Except for two PMA-approved saline-filled breast implants, all other saline-filled breast implants are considered investigational devices because they are not PMA- approved. For a woman to receive an investigational saline-filled breast implant in the U.S., she must enroll in an investigational device exemption (IDE) study.

An IDE study is a clinical study that must be reviewed and approved by FDA to help assure that the resulting data will be meaningful and that patients will not be exposed to unreasonable risks. IDE studies may include augmentation, reconstruction, and/or revision patients. The number of patients and the number of sites are limited in IDE studies. In addition, each woman who participates in an IDE study must give informed consent.4 The safety and effectiveness data collected in an IDE study are used to support a future PMA.

Additional Liposuction Research:

Saline Breast Implants | Silicone Breast Implants | Breast Augmentation Risks | Breast Augmentation Costs | Breast Augmentation Before & After | Choosing a Breast Augmentation Surgeon | Choosing a Breast Implant | Breast Reconstruction with Breast Implants | Breast Reconstruction with Tissue Flaps | Questions for Your Breast Augmentation Surgeon | Questions for Your Breast Reconstruction Surgeon | Breast Augmentation Glossary