POLYTECH Health & Aesthetics GmbH - Quality Made in Germany Pays Off: CE Approval For Breast Implants From One of the International Leading Companies Currently Confirmed

PR76868

DIEBURG, Germany, December 21, 2018 /PRNewswire=KYODO JBN/ --

On December 18, 2018, POLYTECH sold the three millionth implant since its

establishment in 1986. The company is the only German manufacturer and present

in over 75 countries worldwide. All implants are manufactured in the company's

own production facilities in Dieburg near Frankfurt. As part of the

recertification, the company was granted the CE Mark for POLYTECH and

B-Lite(R)breast implants for another five years in November 2018.

Breast implants have been class III medical devices in Europe since 2003,

making them one of the most closely monitored medical devices ever (like

pacemakers, heart valves and neuro implants). "As the only German manufacturer

with over 30 years of market experience, we are one of the leading

international companies in the field of development and production of silicone

breast implants. The quality of our products and patient safety always have top

priority, and we are fully aware of our responsibility at this point," said

Wolfgang Steimel, CEO of POLYTECH, who has got more than 25 years of

professional experience in this area. The directors responsible for production

and registration are also experienced professionals in this sector. POLYTECH

currently offers the world's largest product portfolio of breast implants,

available with four different surfaces (smooth, textured in two versions and

with a special polyurethane-foam coating). Since July 2018, the innovative

lightweight implants B-Lite(R) have been part of the company's portfolio.

Pioneer in terms of quality

As early as 1995, the company was one of the first manufacturers in the world

to receive CE marking for its products and already followed quality standards

for Class III products at this early stage. With the adoption of the new

European Medical Device Regulation (MDR) in May 2017, which must be fully

implemented by May 2020, the conditions for the registration of products have

already become significantly more stringent. All Notified Bodies must now

recertify for the MDR and demonstrate that they meet the stricter requirements.

Since 2014, the annual audits have been supplemented by regular unannounced

audits.

Risk minimization in terms of patient safety

"We have been working with a Notified Body specialising exclusively in medical

devices since the introduction of the European Medical Devices Directive in

1994, which was the precursor to the new MDR. In addition, we carry out

extensive safety tests with test criteria that significantly exceed the

specified requirements of the relevant standards. In addition to the permanent,

in-process quality controls of the manufactured implants, randomly selected

products are subjected to daily tests and stress tests under extreme

conditions. In addition, as part of the CE recertification, a biological

assessment/analysis was performed by an independent specialist institute.

Biocompatibility and toxicity testing of the implants also ensure their safety.

This is how we live up to our quality standards and have been guaranteeing

consistently high quality for over 30 years, thus ensuring safety for the

physicians and patients who use and trust our products," explains the CEO

Wolfgang Steimel.

More about POLYTECH:

POLYTECH Health & Aesthetics GmbH was founded in 1986 in Dieburg and today is

one of the world's leading companies in the field of development and production

of silicone implants. The focus is on breast implants, which are used in

reconstructive surgery as well as in aesthetic plastic surgery. POLYTECH Health

& Aesthetics is the only German manufacturer of soft tissue implants. All

products are developed exclusively at the company site in Dieburg, Hesse and

manufactured under cleanroom conditions. The company now employs more than 250

people and is active in more than 75 countries worldwide.

http://www.polytechhealth.com.

Press Contact Information

dellian consulting gmbh

Karina Fritz und Margit Dellian

Hegelmaierstr. 24

74076 Heilbronn

Tel: 07131-7973760

E-Mail: k.fritz@dellian-consulting.de;

m.dellian@dellian-consulting.de

Web: www.dellian-consulting.de

SOURCE: POLYTECH Health & Aesthetics