자궁과 질은 골반 내의 근육과 인대 등 지지 구조를 가지고 있다. 이러한 지지 구조가 출산 등으로 약화되고 늘어나서 자궁 혹은 질벽의 위치에 변화를 초래한다. 탈출증은 주로 폐경기 이후에 발생하는데 에스트로겐의 감소가 인대의 약화를 초래한다. 탈출증의 위험은 과체중이나 지속적인 기침 등으로 골반 내의 근육과 인대에 추가적인 힘이 가해질 때 증가한다. 이유는 밝혀지지 않았으나 백인에서 더 흔하다. ...
If there's a recall, getting word out to consumers is efficient and effective. But when it... When problems began to emerge globally with surgical mesh devices used to treat pelvic floor...
[9] Vaginal mesh devices[edit] The transvaginal mesh is a device that is surgically implanted into the vagina to strengthen pelvic muscles or organs, or to treat incontinence. By 2010, Bard...
FDA Orders Mesh Manufacturers to Stop Selling Devices for Transvaginal Repair of Pelvic Organ Prolapse ; On April 16, 2019, after reviewing their premarket approval (PMA) applications, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse (Boston Scientific Uphold Lite, Boston Scientific Xenform, Coloplast Direct Fix Anterior) to stop selling and distributing their products immediately. The FDA determined that the manufacturers, Boston Scientific and Coloplast, did not demonstrate reasonabl ...
An Australian obstetrician has urged the medical profession to learn from the pelvic mesh scandal to ensure it never happens again. Earlier this month Health Minister Greg Hunt issued a...
Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and...
C.R. Bard is a medical technology company specializing in vascular, urology, surgery and oncology devices. Becton, Dickinson & Co. acquired C.R. Bard Inc. in 2017 for $24 billion. Bard medical devices include about 15,000 products. Bard lawsuits have produced millions in settlements and jury verdicts for states and injured individuals. In 1993, the company pleaded guilty to 391 criminal charges stemming from accusations that Bard sold defective heart catheters, hid the problems with the devices from the U.S. Food and Drug Administration and con ...
Sales of Pelvic Mesh, Citing Safety Concerns for Women Share full article 92 The Food and Drug Administration said there was insufficient evidence that mesh worked better than surgery to...
By Victoria Derbyshire ; More than 800 UK women are taking legal action against the NHS and the makers of vaginal mesh implants, the Victoria Derbyshire programme has learned. ; The implants are used to treat pelvic organ prolapse and incontinence after childbirth, but some can cut into the vagina - causing severe discomfort. ; Some women have been left in permanent pain, unable to walk, work or have sex. One called the implants "barbaric". ; The UK's medicines regulator said it "sympathises" with the women affected.
Update to Mesh Hub notifying of recent recall actions