Groupe Sebbin Announces the Launch of One of the World's Largest Long Term Prospective Clinical Trials on Silicone Breast Implants

Monday, November 13, 2017 Clinical Trials News
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BOISSY L’AILLERIE, France, November 13, 2017 /PRNewswire/ --

Groupe SEBBIN is a global medical device company with

over 30 years experience in the development, manufacture and marketing of medical devices for aesthetic and reconstructive surgery. More than 1 million of Sebbin breast prostheses have already been implanted around the world.

     (Logo: http://mma.prnewswire.com/media/558818/Sebbin_Logo.jpg

)

As of today, several clinical trials on SEBBIN breast implants, both prospective and retrospective, have been launched, with about 1500 enrolled patients. These studies, ongoing or already completed, are being conducted worldwide, in up to 10 countries: France, Spain, United Kingdom, Germany, Belgium, Luxembourg, Russia, Israel, Argentina and South Korea. The results of these clinical trials provide medical evidence in breast augmentation as well as in breast reconstruction.

In this context, Groupe SEBBIN announces they have just closed the inclusion phase of a prospective, multicenter clinical study including nearly one thousand patients with indications of implant-based breast augmentation or reconstruction. Sixteen European surgeons from University Hospitals and private clinics are taking part in the project and will follow patients over a 10-year period, in order to assess the long-term safety and effectiveness of SEBBIN silicone gel-filled breast implants.

Diederik Van Goor, CEO of group Sebbin states:

"Patient safety is our priority. Over the past 30 years, we have put considerable energy in collecting and communicating data about the safety and effectiveness of our products. Previously published studies about SEBBIN devices have reported particularly low complication rates and high patient satisfaction when compared to similar reports in the scientific literature.

Today we are very proud to announce we have just closed patient inclusion in what has become one of the largest prospective multicenter long term clinical study on breast implants.

In the constantly evolving world of breast implants, only large scale prospective clinical trials allow accurate assessment of complication rates as well as patient-related benefits.

As part of our commitment to transparency, all findings of this study will be published and made available to the scientific community.

I would like to thank all sixteen investigators and their institutions, from Barcelona to Moscow, who made this project possible."

In a first 10-year clinical study on SEBBIN silicone breast implants, results showed a low rate of capsular contracture of 5.0%, and a rupture rate lower than 11% (rates obtained with Kaplan-Meier method).

About Sebbin: 

Groupe Sebbin is a global medical device company headquartered in France established for more than 30 years. It creates, develops, manufactures and markets high quality implants, expanders and other solutions for aesthetic and reconstructive surgery.

All products are manufactured with the upmost care and attention at its cutting-edge facility close to Paris. Strict quality control over 100% of their silicone implants ensures optimum safety for the patient.

PATIENT SAFETY IS THE NUMBER ONE PRIORITY AT ALL TIMES.

Group Sebbin uses only long-term implantable medical grade silicone registered by the FDA (Food & Drugs Administration). The application of ISO 9001 and 13485 standards ensures full compliance with the requirements of European Directive 93/42. 

Contact : Groupe Sebbin 39-43 Parc d'Activités des Quatre Vents 95650 Boissy l'Aillerie - France Tel : +331-3442-1328 Email : [email protected]

Website: www.sebbin.com

SOURCE Groupe Sebbin



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