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February 06, 2012

A Word About PIP/French Breast Implants

You may have read recently about safety concerns with French-made PIP silicone breast implants.  If you are one of my patients, thankfully, you are not part of this European debacle.

I am posting to reassure my patients that I do NOT use PIP implants.  If you are one of my patients, and if you have recently undergone breast augmentations or reconstructions, please rest assured that your implants were made either by Mentor or by Allergan--not by PIP.  Both Mentor and Allergan are headquartered in the USA, and neither is being scrutinized for quality or safety concerns.

So, you are OK!

How did we in the United States manage to miss the PIP (Poly Implant Prothese) controversy?  Please thank the United States government; as early as 2000, the FDA had raised concerns about the implants manufactured by PIP.  In 1996, PIP had started selling its pre-filled saline implants in the United States under a 510(k) accelerated review application that did not require the company to submit clinical trials as long as the implant was said to be "substantially equivalent" to those already on the market.  However, by 2000, the FDA required all breast implant manufacturers to submit a formal application (known as a "pre-market approval").  Three companies submitted applications - Inamed (now Allergan), Mentor (now a division of Johnson & Johnson), and PIP.  Two companies received approval:  Inamed (Allergan) and Mentor.  PIP did not.  PIP then stopped selling its pre-filled saline implants in the United States.  That is why, although over 30,000 pre-filled saline implants manufactured by PIP have been reported sold in the United States, none of the offending PIP silicone implants have ever been implanted in the United States.

Unfortunately, PIP did not self-critique upon its expulsion from the American market.  It never addressed its quality issues.  PIP has been using a cheaper industrial-grade silicone in their silicone gel breast implants, rather than medical-grade silicone.  When this information came to light, PIP was finally shut down altogether.

But damage has been done.  These cheap PIP silicone implants are much more prone to rupture and leakage than normal.  Many European health commissions have recommended PIP implant removal (and replacement with new, safe implants from either Mentor or Allergan) as a precautionary measure.  While there appears to be no evidence of a cancer link due to these implants, we can never be sure.

I would like to reiterate that the implants that I use in my practice, made by Allergan or Mentor, are FDA-approved, and have an excellent track record.  However, I do frequently see patients whose breast surgery was done in Mexico and elsewhere.  IF YOUR IMPLANTS WERE PLACED AT A FACILITY NOT IN THE UNITED STATES, PLEASE CHECK TO SEE WHETHER YOU HAVE PIP-BRAND SILICONE IMPLANTS.  If you do have them, please come and talk to me about an implant exchange.  This is very important.  Your health may depend upon it.

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