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Silicone Breast Implants

Friday, September 30, 2011

In the United States of America, the Food and Drug Administration (FDA) continues to debate whether the current makes of silicone breast implants are safe.

Diana Zukerman, President of the National Research Centre for Woman and Families, a research and education group, told an expert panel that the 2 companies that manufacture silicone breast implants – Johnson & Johnson & Allegan – had done a poor job of studying patients who got the implants, as the FDA required them to do.

“And without proper data, we still don’t know how safe or effective they are and whether there are certain patients at risk for extremely negative outcomes,“ Ms Zukerman says.

The FDA agree that the studies conducted by the 2 companies had failed to follow as many patients as the FDA had hoped.  One of the criticisms of the study was that the patients who participate are required to complete a 27 page research form.  The hope was expressed that a registry could be created that would follow all breast implantations, but such registries are expensive to maintain and complicated to create.

The FDA has a requirement that all patients with silicone breast implants should have a magnetic residence imaging test 3 years after receiving the implants and every 2 years thereafter.

However, many patients ignore the requirements because MRI’s are expensive and it is unclear what they should do when unseen rupture is discovered.  Should they undertake the risk and expense of further surgery or should they observe the rupture to see if the silicone spreads?

The FDA recognizes that there any many risks including ruptures, a hardening of the area around the implants, the need to remove the implants, scarring, pain, infection and asymmetry.  Nevertheless the FDA continues to believe that the currently marketed silicone breast implants are safe.

What is indisputable however is that saline implants are a lot safer!  Saline implants have now been used for more than 40 years.  Leakage is now extremely rare.  When it occurs it is readily detectable as the breast slowly diminishes in size.  There is no need to perform an MRI every 2 years and, if a saline implant does leak, then it is easy to remove and replace.  So long as the saline implant has a soft smooth shell and is placed partially under the pectoral muscle, then it is extremely difficult to tell the difference between the saline implant and a silicone implant.

Patients who have saline implants also appreciate the fact that their incision (and therefore their scar) is a lot shorter than that required for the insertion of an equivalent size silicone implant as a saline implant can be folded and is only inflated once inside the breast.

With so many advantages, it is little wonder that many women are turning to saline breast implants because of the safety and peace of mind that they offer.

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