After the first status report of the FDA on a possible association of breast implants and the incidence of ALCL in January 2011, the agency released an update on Breast-Implant Associated ALCL (BIA-ALCL) on 21 March 2017. At the time, the FDA had received 359 reports on BIA-ALCL. In their update, the FDA confirms that the disease is rare and provides several sources of evidence to this effect.

Presently, the agency does not recommend a change of handling pertaining to the use of breast implants in breast augmentation or reconstruction surgery. For patients who already have implants and are without symptoms, the FDA sees no need for action. Patients who suffer from pain and swelling are requested to make an appointment with their health-care provider to exclude any suspicion of BIA-ALCL.

Health-care providers are called upon to include the discussion of the low risk of BIA-ALCL, among that of other possible complications, in their pre-operative patient education and the informed consent.

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Missed watching the live transmission of our webinars?
You can now watch the videos recorded at Dr Constantin Stan‘s S Clinic in Bucharest, Romania.

Webinar 4 NOV 2016: Microthane® Breast Implants - a valuable tool in breast surgery
Faculty: Dr Mario Pelle Ceravolo, Dr Tom Biggs, Dr Sühan Ayhan, Dr Patrick Tonnard, Dr Alexis Verpaele, Dr Giovanni Botti, Dr Moustapha Hamdi, Dr Constantin Stan
Go to: www.sclinic.ro/webinar

Webinar 21-22 FEB 2017:  "One Day & A Half" Breast Course
Go to: www.sclinic.ro/livecourse

Webinar 20 MAR 2017: Gluteal Surgery
Faculty: Dr Raul Gonzalez, Dr François Petit, Dr Constantin Stan
Go to: www.sclinic.ro/webinar-march

 

The first clinical paper on Microthane® breast implants has been published by the Aesthetic Surgery Journal:
The Modern Polyurethane-Coated Implant in Breast Augmentation: Long-Term Clinical Experience

Please follow the link to access the PDF of the free study abstract, which contains publication references.

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On 16 October 2015, Wilfried Hüser, the founder of the only German manufacturer of soft-tissue implants, was awarded the Heinrich-Bürkle-de-la-Camp-Medal.

Dieburg, 20 October 2015. For his achievements in the medical-devices industry, Wilfried Hüser, founder and owner of the German company POLYTECH Health & Aesthetics GmbH, was awarded the Heinrich-Bürkle-de-la-Camp-Medal. The awards ceremony was held during the opening event of the 53rd Congress of the German Society of Plastic and Reconstructive Surgery (DGPW) in Dusseldorf. The soft-tissue implants of the German company are used in reconstructive and aesthetic surgery, for example following an accident or breast cancer and for compensating congenital defects.

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POLYTECH Health & Aesthetics was founded in 1986 and since has become one of the leading breast implant manufacturers in Europe. The company only sells breast implants made exclusively at its production site in Dieburg, Germany. POLYTECH Health & Aesthetics is the only German manufacturer of implants destined for soft-tissue replacement. In 2008, the complete production had been relocated to Germany. Since then, each single production step has been performed and monitored directly in Dieburg, Germany, be that product development, shell production, gel filling, sterilisation, quality management or regulatory affairs, just to name a few. "This degree of control and product quality may be achieved best in Germany," states Dr Oliver Bögershausen, Managing Director and Head of Quality and Safety Management. The company does not sell breast implants produced in foreign countries.

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German brands possess a good reputation worldwide and are synonymous for superior quality and high-end craftsmanship. POLYTECH Health & Aesthetics is the only German manufacturer of silicone implants and has been marketing them successfully for more than 25 years. As a European leader in implant development with production facilities located exclusively in Germany, we manufacture all our implants according to international quality standards and German quality requirements. Continue…

The scandal regarding faulty French breast implants did not affect German implant manufacturer POLYTECH Health & Aesthetics. The medical-grade silicone uses in our implants is specially certified for long-term implantation. At our production site in Germany, we regularly perform extensive quality and safety tests. We examine our implants after each production step to ensure that they comply with the highest standards. Continue…

The recently published results of the annual patient survey by DGAePC, the German Society for Aesthetic Plastic Surgery, show that breast enlargement with silicone implants is still number one on the list of the most frequently performed aesthetic plastic surgeries in Germany. Continue…

“Six months after the hype on substandard silicone implants, the demand for breast enlargements remains as strong as ever. The only German [breast implant] manufacturer has had to increase production to fulfil the number of orders coming in from all over the world.” Focus online, 5 July 2012    Continue…

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