Cereform Implants: The Newest Recalled

In the wake of the Poly Implant Prosthese (PIP) scandal, another implant is being recalled from international markets. Cereform breast implants are being pulled from Australian, French, and other international markets because the implants were not manufactured up to international standards. While there are no recorded incidents of infection or any other adverse side effects, surgeons are being warned not to put these implants in patients, forcing thousands of doctors with connections to Cereform to postpone surgeries before they can find a suitable replacement.

Luckily, these implants were not approved by the Food and Drug Administration (FDA) in the US, so US women are safe. However, this incident has served as a warning for American women thinking of buying illegal or grey market implants.

The Grey Market

Essentially a black market for implants, the grey market is the figurative “place" you can get non-FDA approved implants. But you don't meet a person in a shady alley to get them. Usually, you get these implants through your doctor—who, if he is peddling grey market implants, should not be trusted. These doctors will tell you the implant is completely safe and is in the process of getting approved by the FDA. In Cereform's case, this is completely untrue. Cereform implants have been marked unsafe by the FDA.

Before the ban on silicone was lifted in 2006, many women in the US got their implants off of this market. Though the ban was later lifted, buying these implants off of the grey market was still a bad idea. You never know what you're actually getting on the grey market. Like at the swap meet, you could be getting a genuine Louis Vuitton wallet, but more than likely, you are getting a cheap rip-off.

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Why FDA Approval Is Important

As the overseer of all food, drugs, and other medical products, the FDA protects you from millions of potential dangers. This organization has four branches:

  • Medical products and tobacco
  • Foods and veterinary medicine
  • Global regulatory operation and policy
  • Operations

The FDA's grip is tight on implant manufacturers, meaning that manufacturers must do a lot to be approved by the FDA. Just to gain approval, the implant manufacturer must comply with governmental studies on the health and safety of the implants. In the case of silicone implants, this also meant post-approval studies to confirm their safety. After or during the approval process, the FDA can show up to an implant manufacturer's plant without any warning for an inspection. In Europe and other countries, the FDA equivalent must give 10 days' warning before showing up, allowing implant manufacturers a chance to clean up their act.

That's why there are only three implant manufacturers on the US market currently: Allergan, Sientra, and Mentor. These three manufacturers had to pass rigorous tests in order to be approved by the FDA and sold on the US market. These three were also battling aversion to silicone implants before the ban was lifted in 2006. Unlike these manufacturers, Cereform could only enter the US through illegal means because it was not FDA approved. If you have purchased a Cereform implant through illegal channels, contact an American Society of Plastic Surgeons approved surgeon for a consultation.

To find a qualified plastic surgeon, click here.

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