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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