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Hernia Mesh Manufacturers __________________________ Ethicon Physiomesh - J & J Atrium - Maquet - Getinge Group Parietex Lightweight - Covidien Proceed Hernia Mesh C.R. Bard -Davol Hernia Mesh Atrium C-Qur Mosiac Mesh 3DMax - Hernia Mesh by Bard Perfix Plug Hernia Mesh - Davol Ventralex ST Hernia Mesh- Bard Sepramesh Hernia Mesh - Davol Covidien Hernia Mesh - Medtronic Surgipro Auto Suture - Medtronic Parietex Plug & Patch - Medtronic Symotex Hernia Mesh - Medtronic C-QUR Mesh - Atrium Medical Atrium C-QUR Mesh Atrium C-Qur Mesh V Patch Atrium C Qur Edge Mesh Atrium TacShield Hernia Mesh Atrium Lite Mesh C.R. Bard 3D Max C.R. Bard AlloMaxBard Soft Mesh C.R. Bard Composix C.R. Bard OnFlex C.R. Bard Phasix Mesh C.R. Bard Visilex Ethicon / J&J Mesh Brands Ethicon Physio Mesh Ethicon Proceed Ethicon Proline Ethicon Ultrapure Ethicon Ultrapure Advanced Ethicon XCM Biologic Ethicon FlexHD Medtronic Permacol Medtronic Progrip Medtronic Versatex
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FDA Vaginal Mesh Erosion Warning
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Device in Question:
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.
Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.
Purpose:
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI. Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.
The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA's activities involving surgical mesh for the transvaginal repair of POP. See: FDA Mesh Warning to Doctors 2008
The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.
For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.
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NOTE: Never start, pause or stop taking prescribed medicines or change your dosages or medical treatment or therapies without consulting with a physician that knows your unique medical condition(s). Nothing on this website should be relied on as medical advice. It is provided for general background information only. Always consult a medical professional for your personal and specific medical concerns or questions.
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