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2 As a note, one concern that relates specifically to saline-filled breast implants is the potential for the saline to become contaminated (not sterile) with fungus or bacteria and then released into the woman's body if her implant ruptures/deflates or if the valve leaks. However, saline-filled implants are now generally filled from a bag and tubing rather than from an open bowl, and this procedure may reduce the risk of this complication.
STATUS / AVAILABILITY
Saline-Filled Breast Implants
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.
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