Declaration by the FDA
The FDA (American Food and Drug Administration) published a declaration concerning the public consultation hearing on March 2019 breast implants and the associated risk of anaplastic large cell lymphoma associated with breast implants (BIA-ALCL). They announced new measures to provide women with the necessary information about breast implants.
The FDA has assessed all of the available evidence regarding the safety and risks of breast implants, including a comprehensive review of study data, medical device reports, scientific literature and public debates, in addition to organizing a meeting of the public advisory committee on the subject. subject in March.
The FDA concluded that there was insufficient evidence supported by the data to support a ban on textured breast implants, but believes that women and providers should be properly informed of the risk of BIA-ALCL and informed that the risk is higher with the use of textured implants, although still low.
“ This decision by the FDA is in line with the position of ISAPS according to which the ban on textured implants covered with polyurethane is an inappropriate decision in terms of patient safety, when ‘it is based on the data currently available “, explains Dr Dirk Richter , president of the International Society of Aesthetic Plastic Surgery.
With his European colleague, Dr Ivar van Heijningen , president of the European Association of Plastic and Aesthetic Surgery Societies (EASAPS), he shared the following important points:
- BIA-ALCL is an extremely rare detectable and curable disease.
- Textured implants can always be indicated in aesthetic and reconstructive cases in order to give the best possible results or the least risk of complications.
- Information on BIA-ALCL must be included in the preoperative information of any patient receiving a textured breast implant.
- No evidence-based data suggests removal of any implant prophylactically.
- We have no data to support the ban on any of the certified breast implants currently in use.
- Patients whose breast implants have no symptoms have nothing to do.
- Unexpected breast swelling or breast lump should be examined by your plastic surgeon or other doctor.
- Specific recommendations on the use of textured and smooth implants may vary from country to country depending on the recommendations of their health authorities. Plastic surgeons responsible for indications on implants must follow national recommendations until international consensus is reached and implemented.
The International Society of Plastic and Aesthetic Surgery (ISAPS) is the world’s leading professional body for certified plastic cosmetic surgeons. Founded in 1970, ISAPS provides an open forum for the exchange of knowledge in cosmetic plastic surgery worldwide. The Society offers its members up-to-date and continuous training, and regularly organizes and supports scientific meetings around the world.
Today, ISAPS counts among its members the most respected cosmetic surgeons and reconstructors in 107 countries.
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