FDA Orders Transvaginal Mesh Studies
Jan 5, 2012 | Parker Waichman LLP
As part of its ongoing safety review of transvaginal
mesh devices, the U.S. Food & Drug Administration (FDA) has asked 33
manufactures of such products to conduct safety studies assessing their use in
procedures to repair pelvic organ proplapse (POP) and stress urinary
incontinence (SUI). According to various media reports, Johnson & Johnson,
C.R. Bard Inc., Endo Pharmaceuticals Holding Inc., Boston Scientific Corp. and
other companies have been sent letters from the FDA...
Transvaginal Mesh Not a Good Choice for Most Women in POP Repair, Medical Groups Warn
Nov 22, 2011
Two prominent physician groups have recommended that
transvaginal mesh devices not be used in the majority of women who undergo
surgical repair for pelvic organ prolapse (POP). According to a joint statement
issued by the American College of Obstetricians and Gynecologists and (the
College) the American Urogynecologic Society (AUGS), transvaginal placement of ransvaginal placement of surgical mesh may cause some women to suffer "permanent
and life-altering problems, including pelvic pain and painful sexual...
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