Textured Implants Approved by the FDA

May 8, 2019 | Education, News

The American FDA (Food and Drug Administration) has approved the continued use of textured surface Breast Implants.

This follows growing discussions in recent years 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, that they have worked diligently to fill the gaps in knowledge by evaluating the body of available evidence regarding the safety and risks of textured breast implants. This includes concerns specific to the relationship between textured implants and the risk of BIA-ALCL.

The FDA has also announced several new steps aimed at helping women have access to the information they need relating to breast implants. This information includes product material 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.  

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.

Disclaimer: Please note any information provided should be used only as an information guide and not CosMediTour giving advice. Do your own valid surgery research and seek advice from a General Practitioner to enable you to be fully informed about surgery. CosMediTour Surgery Terms & Conditions apply.

Cosmeditour

Written by Cosmeditour

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