Silicone Gel Implants San Francisco

Although silicone gel have always been available qualifying women, yesterday the FDA further eased restrictions. This means that now silicone implants are an available option for breast augmentation for the majority of women. Saline implants will continue to be available, and will still be the best choice for many patients.

Along with approval come some additional restrictions. Here are a few items identified by the FDA:

  1. While saline implants are available for women age 18 years and older, silicone gel implants are only available for women age 22 and over.
  2. To detect "silent" leaks in the implant an MRI of the breast is recommended at three years after the initial surgery and every two years after that.
  3. Recommendations may change as long term data continues to be collected, and to facilitate follow-up, a patient registry will be established.
  4. Because of concerns with damaging the implants, silicone filled implants should not be placed transumbilically or with the TUBA technique.

Additional information can be found at http://www.breastimplantsafety.org and on the FDA web site http://www.fda.gov/cdrh/breastimplants/index.html

When considering whether to proceed with breast augmentation it is import to discuss the risks, benefits, procedure, alternatives and recovery with a Board Certified Plastic Surgeon. Many of the risks associated with saline and silicone filled breast implants are similar; however, there are some differences between saline and silicone gel filled implants.

Future note: Some of the problems specific to silicone gel filled breast implants are linked to leakage. The "Gummi-Bear," form stable implants are soft solids - more like Jello® than a liquid. The upside is, they can't leak, so MRI's may not be required. For reconstructive patients (after mastectomy) the implants can be made into a larger variety of shapes. The downside they require a larger incision for placement.

News on these next generation silicone gel implants will hopefully come soon. These implants have been used in Europe for many years. It should be noted that it took Europe less than one year to lift restrictions on silicone gel implants, and this is really is what allowed the advancement to form stable implants. Canada approved the "Gummi-Bear" form stable implants last year. Maybe next year for the US?