USA: Baldige Rückkehr von Silikonimplantaten
USA: Baldige Rückkehr von Silikonimplantaten
"Nachdem sie elf Jahre lang verboten waren, dürfen in den USA demnächst wieder Silikonimplantate zur Brustaugmentation verwendet werden. Ein Beraterkomitee der FDA sprach sich in dieser Woche für die Zulassung eines Präparates aus. Voraussetzung ist allerdings eine Weiterbildung des Chirurgen und eine Information der Patientin über die möglichen Risiken...1992 hatte die FDA entschieden, die Zulassung dieser Produkte ruhen zu lassen, nachdem Studien auf mögliche medizinische Risiken, etwa die Auslösung von Autoimmunerkrankungen, hingewiesen hatten. Seither waren in den USA nur noch Implantate mit Kochsalzfüllung zugelassen, die jedoch von vielen Frauen abgelehnt werden. Silikonimplantate durften nur noch im Rahmen klinischer Studien verwendet werden. Inzwischen gelten die spezifischen Bedenken gegen Silikon als wissenschaftlich widerlegt. Es bleiben jedoch die allgemeinen Risiken, die mit Brustimplantaten verbunden sind und die nach dem Votum der Experten den Frauen nicht vorenthalten werden dürfen (Häufigste Komplikationen u.a: Reoperation, Kapselkontraktur, Narbenbildung, Schmerzen in der Brust)
http://www.inamed.com/media/press/101503.html
FDA Advisory Panel Recommends Approval of INAMED's Gel-Filled Breast Implants
Santa Barbara, Calif., October 15, 2003 - Inamed Corporation (Nasdaq: IMDC), a global healthcare company, today announced that the General and Plastic Surgery Advisory Panel of the U.S. Food and Drug Administration (FDA) recommended, with conditions, approval of the Company's premarket approval (PMA) application to market gel-filled breast implants in the United States. The Panel voted that the FDA should approve, with conditions, Inamed's gel-filled breast implants for all indications -- breast augmentation, reconstruction and revision.
"This positive recommendation by the Advisory Panel is an important decision for the many women who seek more options when considering reconstruction, augmentation or revision surgery," said Nick Teti, Chairman, President and Chief Executive Officer of Inamed Corporation. "We look forward to working with the FDA during the next step of this process."
In connection with the recommendation, the Panel voted to adopt several conditions designed to address issues relating to patient follow-up, patient informed consent and surgeon education/verification, among other issues.
Inamed manufactures and sells gel-filled implants internationally in more than 60 countries. For more than a decade, gel-filled implants in the U.S. have been restricted to patients undergoing reconstruction or revision surgery and who are also participating in clinical studies. If the panel's recommendation is adopted by the FDA, Teti added, "The same choices that are available to women in 60 countries worldwide we hope will soon be available to women in America."
About Inamed Corporation
Inamed (Nasdaq: IMDC) is a global healthcare company with over 25 years of experience developing, manufacturing and marketing innovative, high-quality, science-based products. These products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the LAP-BAND® System for morbid obesity. The Company's web site is www.inamed.com.
Forward-Looking Statements
This press release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject
to a number of uncertainties and risks that could cause actual results to differ or differ materially from those described in the forward-looking statements. Inamed is providing this information as of October 15, 2003 and expressly disclaims any duty to update information contained in this press release.
This press release contains additional forward-looking statements, including, without limitation, consideration of Inamed's silicone gel-filled breast implant pre-market approval (PMA) application at an FDA Advisory Panel meeting held on October 14 and 15, 2003 and Inamed's anticipated product development program. These forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially from those expressed or implied here. Readers are referred to the documents filed by Inamed with the Securities and Exchange Commission, specifically the most recent reports which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements.
The information contained in this press release is a statement of Inamed's present intention, belief or expectation and is based upon, among other things, the existing regulatory environment, industry conditions, market conditions and prices, the economy in general and Inamed's assumptions. Inamed may change its intention, belief or expectation, at any time and without notice, based upon any changes in such factors, assumptions or otherwise. Inamed undertakes no obligation to review or confirm analysts' expectations or estimates or to state publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
By including any information in this press release, Inamed does not necessarily acknowledge that disclosure of such information is required by applicable law or that the information is material.
Contact:
Robert S. Vaters
INAMED Corporation
(805)692-5420
Media Contact:
Rod Young or Rebecca Smith
McGinn Group
(703) 312-0147
INAMED Corporation
5540 Ekwill Street
Santa Barbara, CA 93111
(805) 692-5400 Telephone
(805) 692-5432 Facsimile
"Nachdem sie elf Jahre lang verboten waren, dürfen in den USA demnächst wieder Silikonimplantate zur Brustaugmentation verwendet werden. Ein Beraterkomitee der FDA sprach sich in dieser Woche für die Zulassung eines Präparates aus. Voraussetzung ist allerdings eine Weiterbildung des Chirurgen und eine Information der Patientin über die möglichen Risiken...1992 hatte die FDA entschieden, die Zulassung dieser Produkte ruhen zu lassen, nachdem Studien auf mögliche medizinische Risiken, etwa die Auslösung von Autoimmunerkrankungen, hingewiesen hatten. Seither waren in den USA nur noch Implantate mit Kochsalzfüllung zugelassen, die jedoch von vielen Frauen abgelehnt werden. Silikonimplantate durften nur noch im Rahmen klinischer Studien verwendet werden. Inzwischen gelten die spezifischen Bedenken gegen Silikon als wissenschaftlich widerlegt. Es bleiben jedoch die allgemeinen Risiken, die mit Brustimplantaten verbunden sind und die nach dem Votum der Experten den Frauen nicht vorenthalten werden dürfen (Häufigste Komplikationen u.a: Reoperation, Kapselkontraktur, Narbenbildung, Schmerzen in der Brust)
http://www.inamed.com/media/press/101503.html
FDA Advisory Panel Recommends Approval of INAMED's Gel-Filled Breast Implants
Santa Barbara, Calif., October 15, 2003 - Inamed Corporation (Nasdaq: IMDC), a global healthcare company, today announced that the General and Plastic Surgery Advisory Panel of the U.S. Food and Drug Administration (FDA) recommended, with conditions, approval of the Company's premarket approval (PMA) application to market gel-filled breast implants in the United States. The Panel voted that the FDA should approve, with conditions, Inamed's gel-filled breast implants for all indications -- breast augmentation, reconstruction and revision.
"This positive recommendation by the Advisory Panel is an important decision for the many women who seek more options when considering reconstruction, augmentation or revision surgery," said Nick Teti, Chairman, President and Chief Executive Officer of Inamed Corporation. "We look forward to working with the FDA during the next step of this process."
In connection with the recommendation, the Panel voted to adopt several conditions designed to address issues relating to patient follow-up, patient informed consent and surgeon education/verification, among other issues.
Inamed manufactures and sells gel-filled implants internationally in more than 60 countries. For more than a decade, gel-filled implants in the U.S. have been restricted to patients undergoing reconstruction or revision surgery and who are also participating in clinical studies. If the panel's recommendation is adopted by the FDA, Teti added, "The same choices that are available to women in 60 countries worldwide we hope will soon be available to women in America."
About Inamed Corporation
Inamed (Nasdaq: IMDC) is a global healthcare company with over 25 years of experience developing, manufacturing and marketing innovative, high-quality, science-based products. These products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the LAP-BAND® System for morbid obesity. The Company's web site is www.inamed.com.
Forward-Looking Statements
This press release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject
to a number of uncertainties and risks that could cause actual results to differ or differ materially from those described in the forward-looking statements. Inamed is providing this information as of October 15, 2003 and expressly disclaims any duty to update information contained in this press release.
This press release contains additional forward-looking statements, including, without limitation, consideration of Inamed's silicone gel-filled breast implant pre-market approval (PMA) application at an FDA Advisory Panel meeting held on October 14 and 15, 2003 and Inamed's anticipated product development program. These forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially from those expressed or implied here. Readers are referred to the documents filed by Inamed with the Securities and Exchange Commission, specifically the most recent reports which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements.
The information contained in this press release is a statement of Inamed's present intention, belief or expectation and is based upon, among other things, the existing regulatory environment, industry conditions, market conditions and prices, the economy in general and Inamed's assumptions. Inamed may change its intention, belief or expectation, at any time and without notice, based upon any changes in such factors, assumptions or otherwise. Inamed undertakes no obligation to review or confirm analysts' expectations or estimates or to state publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
By including any information in this press release, Inamed does not necessarily acknowledge that disclosure of such information is required by applicable law or that the information is material.
Contact:
Robert S. Vaters
INAMED Corporation
(805)692-5420
Media Contact:
Rod Young or Rebecca Smith
McGinn Group
(703) 312-0147
INAMED Corporation
5540 Ekwill Street
Santa Barbara, CA 93111
(805) 692-5400 Telephone
(805) 692-5432 Facsimile
sil - 31. Okt, 20:10
