Make Me Over: Silicone implants-safe or not?

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Posted 3:53 PM 1/26/2012 : Make Me Over: How safe are U.S. breast implants?

TUCSON - In today's "Make Me Over" on News 4 at 4, a scandal has renewed fears of just how safe breast implants are.

Dr. Gwen Maxwell stopped by the News 4 Tucson studios today to discuss the PIP Implant scandal, and the safety of breast implants in the U.S.

Here's what she had to say:

PIP Breast Implant Facts:
• The French Government closed down the PIP factory in 2010 after learning the company filled implants with industrial grade silicone instead of medical grade silicone, which resulted in an unusually high rupture rate.

• Recently French, German, and Czech governments advised women to have their implants removed due to the high rupture rate.

• The PIP implants were sold worldwide including Europe, South America, and Asia.
• Implants with industrial silicone are more likely to rupture, leaking a gel that can cause scar tissue and inflammation, the French Health Ministry said in a Dec. 23 statement. The silicone is more typically used to make mattresses, the British Association of Aesthetic Plastic Surgeons said in its statement Dec. 3.

• To the best of our knowledge, PIP silicone gel implants were never approved for use in the United States. An American would need to have had surgery outside the United States in order to have received the implants that are now the subject of concern.

How safe are implants in the United States?

• Silicone implants were FDA approved in 2006 with the condition that the manufacturers keep detailed studies on 40,000 patients to access the long-term performance and safety of the devices.

• Only two companies, Mentor (MemoryGel) and Allergan (Natrelle) currently have FDA approval to produce and sell silicone gel and saline breast implants in the United States.

• PIP sought approval from the FDA but was rejected.

• The studies rely on voluntary participation from patients.

• So far the studies have found similar results on rates of complications and no apparent link between silicone implants and breast cancer or reproductive disease.

• In August 2011, the FDA had hearings to review the studies results thus far and ruled that the implants are safe enough for continued use.

• Dr. Maxwell prefers to use Mentor implants as they produce all of their implants for the U.S. in Dallas, Texas which not only ensures a safer product, but supports the economy here in the U.S.

• Mentor only uses medical-grade silicone in their gel-filled implants and they adhere to strict quality manufacturing requirements. The silicone shells that have been tested and shown to possess excellent strength, resilience and elasticity. Mentor also conducts extensive bio-compatibility testing on all its breast implants.

This situation underscores yet again the safety concerns with having cosmetic procedures done overseas. Buyers not only have to be concerned with the credentials of the medical personnel, and the facility, but also the use of products that are not FDA regulated or approved.