"Why are breast implant manufacturers not using their device registry to send updated health & safety information to warn women of Breast Implant Associated-Anaplastic Large Cell Lymphoma (ALCL)?"
Currently, the NWHN is trying to improve the standards of how devices and procedures get approved while stressing that women should be informed of the risks of procedures in a timely manner. We have consumer health information on silicone breast implants noting that the FDA has asked implant manufacturers to notify women receiving implants that they will need regular MRI exams to detect ruptures, but manufacturers are still failing to provide this warning.
There is a way you can take action and access this information. You can always refer to the FDA Adverse Event Reporting System (FAERS). The FAERS is a collection of case report files that present drug, reaction, and patient outcome information on any drug, device or procedure. It’s not a searchable database, but the FDA will send you a summary of a report for a product by sending them a Freedom of Information Act (FOIA) request. They have a link with instructions on how to compose the request and it can be mailed, faxed, or submitted online. The FDA also allows consumers to submit individual case safety reports and their site has instructions on how to do so. Feedback from consumers is a crucial part of giving the FDA information that will help women make decisions about their health. If you’ve had an adverse reaction to a device or procedure, don’t hesitate to make your voice heard.
The current information about breast implants and ALCL conclude that there is a low but increased risk of developing this cancer from implants. In 2011, the FDA found 60 cases of ALCL out of 5-10 million women with breast implants and they now have a current estimate of 100-250 known cases. A study done by the National Cancer Institute (NCI) showed that women who had implants for seven years had a 21% increase of risk for cancer when compared with women around the same age, but the type of cancer was not exclusive to ALCL. The NWHN’s position is that silicone breast implants have not been proven to be safe for long-term use and we will continue to push for the FDA to crack down on implant manufacturers resisting long-term studies on their devices.
See the NWHN’s Consumer Health Info on breast implants for more information on the risks and safety of silicone breast implants. The FDA also provides information on breast implants and ALCL on their site under medical devices.
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