POLYTECH welcomes statement by US Food and Drug Administration FDA opposing ban on textured breast implants

ID: 1549051
recent pressrelease next pressrelease

(PresseBox) - POLYTECH Health & Aesthetics GmbH, a global leader in breast aesthetics, welcomes a recent statement by the FDA that textured breast implants will remain available in the US market, In opposition to the recent decision by the French health authority ANSM (Agence Nationale de S

"The FDA''s argumentation is in line with our view", commented Wolfgang Steimel, CEO of POLYTECH Health & Aesthetics, applauding the decision. "Because there is still no sound scientific proof regarding how BIA-ALCL arises and develops, nor of a connection with the implant surface," Steimel elaborated. Alongside POLYTECH?a leading international breast implant manufacturer and the only manufacturer in Germany?the International Society of Aesthetic Plastic Surgery (ISAPS) also agrees with the FDA''s position as the world-leading professional association for licensed aesthetic plastic surgeons.

The FDA made its recent statement following the public consultation of its Advisory Committee in March 2019. Having examined all available evidence and data on the safety and risks of breast implants, the United States Food and Drug Administration has concluded that there is insufficient data-based evidence to justify a ban on textured breast implants.

Candid dialogue and transparent education

POLYTECH CEO Wolfgang Steimel added: ?As manufacturers, we have an ethical obligation to patients, which is why we remain in fully candid dialogue, promoting transparent education regarding this topic. Nonetheless, out of our commitments to both patient safety and satisfaction, we are pleased that the criticisms of textured and polyurethane foam/PU-coated implants have again been refuted by others."

Thus, in addition to their silicone-surface implants ? available with a smooth shell and with two different microtextures ? and to the novel Lightweight B-Litethe International Society of Aesthetic Plastic Surgery (ISAPS), agreed with the FDA''s position. Dr. Richter added:" We believe that a ban on textured and polyurethane-coated implants is an improper decision in terms of overall patient safety, when based on the currently available data."



With a global footprint in over 75 countries, POLYTECH Health & Aesthetics GmbH is an international leader in the development and production of silicone implants. Founded in 1986 in Dieburg, Germany, the company focuses on breast implants, used in both reconstructive and aesthetic plastic surgery. POLYTECH is the only German manufacturer of soft tissue implants. All products are developed exclusively at the company headquarters in Germany, and are manufactured under clean room conditions. The company employs over 250 people.

For more information visit https://polytechhealth.com/en



More information:
http://https://



Keywords (optional):



Company information / Profile:

With a global footprint in over 75 countries, POLYTECH Health&Aesthetics GmbH is an international leader in the development and production of silicone implants. Founded in 1986 in Dieburg, Germany, the company focuses on breast implants, used in both reconstructive and aesthetic plastic surgery. POLYTECH is the only German manufacturer of soft tissue implants. All products are developed exclusively at the company headquarters in Germany, and are manufactured under clean room conditions. The company employs over 250 people.For more information visit https://polytechhealth.com/en

PressRelease by

Requests:



PressContact / Agency:



published by: PresseBox
print pressrelease  send to a friend  

Date: 05/15/2019 - 04:12
Language: English
News-ID 1549051
Character count: 3438
Kontakt-Informationen:
Firma: POLYTECH Health&Aesthetics GmbH
Ansprechpartner: Feedback to businesspress24.com about Pressrelease-id:
Stadt: Dieburg
Telefon:

Meldungsart:
Versandart:
Freigabedatum:
Comments:



Number of hits: 433

Linking-Tips:



Direct Link to this PressRelease:






We would appreciate a link in your News-, Press- or Partner-Site.

Comments on this PressRelease






All members: 9 213
Register today: 0
Register yesterday: 0
Members online: 0
Guests online: 45


Don't have an account yet? You can create one. As registered user you have some advantages like theme manager, comments configuration and post comments with your name.

Categories:


[ more PressReleases ][ RSS-Feed ]