The FDA Approves Textured Implants
In recent news, the American FDA (Food and Drug Administration) has approved the continued use of the textured surface breast implants from brands Allergan, Mentor and Sientra. This follows the growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The FDA has confirmed in an in-depth statement released that they have worked diligently to fill the gaps in knowledge, such as evaluating the body of available evidence regarding the safety and risks of breast implants, including concerns specific to textured implants and the risk of BIA-ALCL.
The FDA has also announced several new steps aimed at helping to ensure that women have access to the information they need about breast implants to make informed decisions and to further drive evidence that will help the FDA make the most appropriate scientific regulatory decisions moving forward. Including increasing information available, incorporating product ingredient information into the labelling of breast implants and a patient decision checklist to ensure that all women who consider breast implants have the information they need to have thoughtful discussions with their health care professional about both the benefits and risks of breast implants based on clear information reflecting the most current understanding of these issues.
The FDA believes regulatory action must be based on scientific data. While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis. With a focus on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, the FDA has confirmed that the risk is higher with the use of textured implants, albeit still low.
We will publish more detailed information on BIA-ALCL as we gather further statistics and information from Australian and international sources.
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