Therapy Areas: Devices
ISAPS announces the US FDA's allowance of textured surface breast implant sales
6 May 2019 -

Aesthetic plastic surgery company International Society of Aesthetic Plastic Surgery (ISAPS) said on Friday that The American Food and Drug Administration (FDA) has announced new steps aimed at providing women with the necessary information regarding breast implants and the related risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The US FDA has evaluated the body of available evidence regarding the safety and risks of breast implants, including an in-depth review of study data, medical device reports, scientific literature, and public discussions, in addition to hosting a public advisory committee meeting on the topic in March, added the company.

Based on evidence, the US FDA concluded that there was not enough data-supported evidence supporting a ban on textured-surface breast implants, but believes that women and providers should be adequately informed of the risk of BIA-ALCL and made aware that the risk is higher with the use of textured implants, albeit still low.

According to Dr Ivar van Heijningen, president of the European Association of Societies of Aesthetic Plastic Surgery, EASAPS: BIA-ALCL is an extremely rare condition that is detectable and curable, textured implants may still be indicated in both cosmetic and reconstructive cases, information on BIA-ALCL should be included in the preoperative information, no evidenced-based data suggest removal of any implants prophylactically, unexpected swelling of the breast need to be examined by the plastic surgeon and specific recommendations on the use of textured/smooth implants may vary between the different countries and should follow national recommendations.