The Status of Silicone & Saline Filled Breast Implants in the U.S. (FDA Approval)

While there are many breast implants available throughout the world, there are only two manufacturers which have approved breast implants available to patients in the United States.  Both offer saline and silicone filled breast augmentation prostheses.

"FDA has approved four breast implants for marketing in the U.S.:

  • In May 2000, Mentor and Allergan (formerly Inamed, and before that, McGhan) received approval for saline-filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age.
  • In November 2006, Allergan and Mentor received approval for their silicone gel-filled breast implants. These implants were approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age.

All breast implants other than these four approved devices are considered investigational devices, including the more-cohesive (“gummy bear”) implants. For a woman to receive an investigational breast implant in the U.S., she must enroll in a clinical study." [source: FDA Website]

Cohesive Silicone Filled Breast Implants - "Gummy Bear Implants" or "Gummies"
Both Mentor and Allergan manufacture Cohesive silicone-filled breast implants which are, or were, available through clinical studies.  Mentor's implant is called the Mentor CPG, or Contour Profile Gel.  Allergan has several implants available with varying degrees of cohesiveness, or firmness, and profiles. The Allergan implant collection is called the Natrelle™ 410 Collection.

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This page was last updated: 04/25/2011