FDA approves new silicone gel-filled breast implant
Agency requires post-approval safety studies to assess rare events
The U.S. Food and Drug Administration today approved the Natrelle 410
Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant
to increase breast size (augmentation) in women at least 22 years old
and to rebuild breast tissue (reconstruction) in women of any age.
Natrelle 410 implants are manufactured by Allergan, Inc.
The silicone gel in the Natrelle 410 implant contains more
cross-linking compared to the silicone gel used in Allergan's
previously approved Natrelle implant. This increased cross-linking
results in a silicone gel that's firmer. Cross-linking refers to the
bonds that link one silicone chain to another. The clinical
significance of this type of silicone gel is not known.
The U.S. Food and Drug Administration today approved the Natrelle 410
Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant
to increase breast size (augmentation) in women at least 22 years old
and to rebuild breast tissue (reconstruction) in women of any age.
Natrelle 410 implants are manufactured by Allergan, Inc.
The silicone gel in the Natrelle 410 implant contains more
cross-linking compared to the silicone gel used in Allergan's
previously approved Natrelle implant. This increased cross-linking
results in a silicone gel that's firmer. Cross-linking refers to the
bonds that link one silicone chain to another. The clinical
significance of this type of silicone gel is not known.
Comentarios
Publicar un comentario