FDA Approves Clinical Trial of New Cohesive Gel Technology Breast Implant

First New Silicone-Filled Breast Implant to be Studied In

30 Years, Reports the Women's Implant Information Network



Apr 19, 2001, 01:00 ET from Women's Implant Information Network

    IRVINE, Calif., April 19 /PRNewswire/ -- The Food and Drug Administration
 (FDA) has approved a clinical trial of the first new silicone-filled breast
 implant in more than 30 years, the Women's Implant Information Network
 announced today.  The study, which will begin in early Spring, will examine
 the safety and efficacy of the McGhan Style 410 implant for breast
 augmentation or breast reconstruction following mastectomy.
     The new device, which has been marketed in Europe since 1993, is filled
 with a unique, cohesive silicone gel that is designed to prevent leakage or
 migration of the gel.  The implant's natural, curved profile shape is
 maintained by the cohesive gel, and the implant has orientation marks to
 assist the physician with visual and/or tactile placement during surgery.
     "Silicone implants are preferable to saline for a natural look and feel,"
 said Sandra Finestone of the Women's Implant Information Network (WIIN).
 "This study is important because women seeking breast augmentation and
 reconstruction deserve the most advanced technologies available."
     A total of 440 patients will be enrolled in the multi-center study, with
 half the subjects undergoing augmentation and half undergoing breast
 reconstruction.  Patients will be evaluated pre-, intra- and post-operatively,
 and annually for 10 years following surgery.
     John B. Tebbetts, M.D., F.A.C.S., a Dallas-based plastic surgeon, designed
 the new implant and will personally investigate 55 primary cosmetic
 augmentation cases in the study.
     "It is important to develop and study new options for women.  The silicone
 implants currently used in surgeries in the U.S. were designed 30 years ago,"
 Dr. Tebbetts says.  He is the only physician in the U.S. who has long-term
 experience using the Style 410 in breast augmentation.  He implanted the
 device in more than 60 augmentations in Europe over five years ago, and has
 tracked patient progress since the surgeries.
     Silicone breast implants have been used since the early 1960s for breast
 augmentation and reconstruction.  The safety of silicone-based implants was
 confirmed in 1998, when the National Academy of Sciences Institute of Medicine
 (IOM) published a study evaluating the evidence of an association of silicone
 breast implants with human health conditions.  Of the 1.5 to 1.8 million women
 with silicone implants in the U.S., the report concluded that immunological
 diseases, cancer, neurological diseases, and other systemic conditions did not
 appear to be increased in women with breast implants when compared to women
 without breast implants.
     According to the American Society of Plastic Surgeons, use of breast
 implants has increased 101 percent since 1997.  Last year, more than 200,000
 women underwent breast reconstruction or augmentation.
     Surgical techniques for breast augmentation have advanced significantly
 over the past several years.  "Precise dissection techniques improve the
 patient's overall experience," says Dr. Tebbetts.  "Because of these less-
 traumatic techniques, the need for special brassieres, bandages and draining
 is eliminated, and over 95 percent of patients are back to normal activities
 within 24 hours.  That is a drastic change from traditional breast
 augmentation, which requires up to two weeks to return to normal activities."
 
     WIIN is a national clearinghouse dedicated to providing objective
 information about breast implants to women across the country.  WIIN's
 President, Sandra Finestone, counsels women seeking reconstructive surgery
 following breast cancer and has been a national spokesperson on breast implant
 issues for the past seven years.  Finestone received silicone breast implants
 in 1983 following a double mastectomy and found it difficult to obtain
 detailed, objective information on product and procedure options.  She formed
 the WIIN organization in 1992 to help fill this information gap.  WIIN's
 information line receives calls from hundreds of women needing information on
 implants.  WIIN provides information to women who are considering or who have
 chosen breast implants for reconstruction following breast cancer surgery, as
 well as women who are considering or have chosen breast implants for
 augmentation purposes.
     For additional information, call WIIN at 949-251-1542 or visit
 http://www.thebestbreast.com .
 
 

SOURCE Women's Implant Information Network
    IRVINE, Calif., April 19 /PRNewswire/ -- The Food and Drug Administration
 (FDA) has approved a clinical trial of the first new silicone-filled breast
 implant in more than 30 years, the Women's Implant Information Network
 announced today.  The study, which will begin in early Spring, will examine
 the safety and efficacy of the McGhan Style 410 implant for breast
 augmentation or breast reconstruction following mastectomy.
     The new device, which has been marketed in Europe since 1993, is filled
 with a unique, cohesive silicone gel that is designed to prevent leakage or
 migration of the gel.  The implant's natural, curved profile shape is
 maintained by the cohesive gel, and the implant has orientation marks to
 assist the physician with visual and/or tactile placement during surgery.
     "Silicone implants are preferable to saline for a natural look and feel,"
 said Sandra Finestone of the Women's Implant Information Network (WIIN).
 "This study is important because women seeking breast augmentation and
 reconstruction deserve the most advanced technologies available."
     A total of 440 patients will be enrolled in the multi-center study, with
 half the subjects undergoing augmentation and half undergoing breast
 reconstruction.  Patients will be evaluated pre-, intra- and post-operatively,
 and annually for 10 years following surgery.
     John B. Tebbetts, M.D., F.A.C.S., a Dallas-based plastic surgeon, designed
 the new implant and will personally investigate 55 primary cosmetic
 augmentation cases in the study.
     "It is important to develop and study new options for women.  The silicone
 implants currently used in surgeries in the U.S. were designed 30 years ago,"
 Dr. Tebbetts says.  He is the only physician in the U.S. who has long-term
 experience using the Style 410 in breast augmentation.  He implanted the
 device in more than 60 augmentations in Europe over five years ago, and has
 tracked patient progress since the surgeries.
     Silicone breast implants have been used since the early 1960s for breast
 augmentation and reconstruction.  The safety of silicone-based implants was
 confirmed in 1998, when the National Academy of Sciences Institute of Medicine
 (IOM) published a study evaluating the evidence of an association of silicone
 breast implants with human health conditions.  Of the 1.5 to 1.8 million women
 with silicone implants in the U.S., the report concluded that immunological
 diseases, cancer, neurological diseases, and other systemic conditions did not
 appear to be increased in women with breast implants when compared to women
 without breast implants.
     According to the American Society of Plastic Surgeons, use of breast
 implants has increased 101 percent since 1997.  Last year, more than 200,000
 women underwent breast reconstruction or augmentation.
     Surgical techniques for breast augmentation have advanced significantly
 over the past several years.  "Precise dissection techniques improve the
 patient's overall experience," says Dr. Tebbetts.  "Because of these less-
 traumatic techniques, the need for special brassieres, bandages and draining
 is eliminated, and over 95 percent of patients are back to normal activities
 within 24 hours.  That is a drastic change from traditional breast
 augmentation, which requires up to two weeks to return to normal activities."
 
     WIIN is a national clearinghouse dedicated to providing objective
 information about breast implants to women across the country.  WIIN's
 President, Sandra Finestone, counsels women seeking reconstructive surgery
 following breast cancer and has been a national spokesperson on breast implant
 issues for the past seven years.  Finestone received silicone breast implants
 in 1983 following a double mastectomy and found it difficult to obtain
 detailed, objective information on product and procedure options.  She formed
 the WIIN organization in 1992 to help fill this information gap.  WIIN's
 information line receives calls from hundreds of women needing information on
 implants.  WIIN provides information to women who are considering or who have
 chosen breast implants for reconstruction following breast cancer surgery, as
 well as women who are considering or have chosen breast implants for
 augmentation purposes.
     For additional information, call WIIN at 949-251-1542 or visit
 http://www.thebestbreast.com .
 
 SOURCE  Women's Implant Information Network