A consumer advocate group called “Public Citizen” is calling for an in depth investigation into allegations by a whistle blowing party that one of the companies pushing for permanent silicone breast implant approval has withheld key safety information (most likely to the detriment of the approval of silicone implants), in an effort to make them look safer than they are to gain permanent approval again here in the US. 

The silicone breast implant alternative has been one that has not consistently been available to women who would like a more natural feeling breast implant for quite a few years now, amid safety concerns after several women with this type of breast implant came forward accusing the implants of causing immune system issues as well as other health hazards that were otherwise unexplained. 

The scientist who came forward claims that Mentor Corp. who manufactures one of the silicone breast implants, withheld information about how leak proof the implants are as well as durability and other important health and safety related issues that would be of concern to the FDA.

Some feel that if this investigation is not done, other pharmaceutical and medical device companies will feel it is ok and acceptable to submit only the “good studies” to the FDA when going for approval on a particular device or medication, rather than submitting both the good and bad – in other words, full disclosure of the good bad and ugly.

The FDA has not yet granted either one of the primary manufacturers of silicone implants the right to fully market their products, so this issue may be caught in time, as long as the right people get involved and everything goes as planned. 

This is not the first whistleblower that has come forward with concerns about the safety of the Mentor silicone implants – apparently five others came forward as well and were interviewed, but the FDA is somewhat hand tied on this (don’t quite understand why).  Just be mindful, if you’re thinking of getting implants, then it probably is still safest to go with saline, even if silicone are available at the time you get the operation. 

 

 

This entry was posted on October 19, 2006 at 3:56 pm. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

Posted in Implant News by Breast News Girl No Comments Yet