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The agency also announced the qualification of a tool to aid in the effectiveness assessment of devices used in breast reconstruction.
Implants are extensively tested before approval to demonstrate safety and effectiveness. Still, there are risks associated with all implants
All Biocell textured breast implants will be pulled because they may increase the risk for a certain type of blood cancer.
The FDA does not believe that, on the basis of all available information, textured implants meets the banning standard.
Global reports show nearly 250 new cases of non-Hodgkin lymphoma in women with breast implants.
Breast implants are one way hospitals mark up prices of medical devices to increase their bottom lines.
“There isn’t necessarily a pressure to innovate unless doctors listen to patients.”
Our perspective today is based the decades of work we have done to assess and communicate the benefits and risks of breast implants.
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