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Transvaginal Mesh Infographic Patch

Transvaginal Mesh Patch Itt's Purpose: Transvaginal Mesh Patch was designed to permanently treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). These conditions are caused when a woman's pelvic muscles are weakened and stretched during childbirth and some other instances. The transvaginal mesh patch is a synthetic mesh that is implanted transvaginally (through the vagina) to provide support for the abdominal organs. Serious Side Effects: Erosion and exposure of mesh Recto vaginal fistula Recurrence of POP and SUI Common Side Effects: Urinary problems Irregular bleeding Pain during intercourse Chronic pain and infection 1996 The FDA approves Boston Scientific to manufacture and market first transvaginal mesh patch, Protegen, under its 501(k) approval process. 1998 2/3 Of All Complaints FDA inspection reveals that 1999 nearly 2/3 of all complaints against Boston Scientific are for transvaginal mesh products. Boston Scientific recalls Protegen stating the device "does not produce outcomes that are consistent with the company's standard of performance for its products or customer expectations." The recall was issued after the company received complaints about pain during intercourse and erosion of vaginal tissue. 2003 738 Lawsuits Boston Scientific settles 738 transvaginal mesh patch lawsuits for an undisclosed amount. 2007 The FDA receives more than 1,000 reports that transvaginal mesh products from various manufacturers cause pain, infection, urinary problems, erosion of vaginal tissue, and recurrence of POP and SI. 1,000 Reports 2008 The FDA issues a warning about transvaginal mesh products but only states that adverse side effects are rare but potentially serious. 2010 2011 10% of Women The FDA receives an additional 2,874 reports of adverse side effects caused by transvaginal mesh. It also received 7 reports that the device caused death. Additionally, the FDA estimates that almost 300,000 women have received An FDA advisory panel recommends that transvaginal mesh products be classified as high-risk, therefore transvaginal mesh patch products. requiring manufacturers to conduct studies based on human testing. The FDA also examined data from 110 studies including 11,785 women, and determined that approximately 10 percent of women undergoing 7 Deaths 2012 transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery. The FDA orders 35 transvaginal mesh manufacturers to conduct studies on 2013 the complications associated with transvaginal mesh products. As a result, C.R. Bard stopped marketing its transvaginal mesh products in the United States. Reports indicate that more than 8,000 transvaginal mesh claims have filed and the first transvaginal mesh trial begins. The plaintiff alleges that she underwent 18 Surgeries 1 Woman Federal claims are consolidated through multidistrict litigation and are centralized before the United States District Court surgeries to correct the injuries caused by Johnson & Johnson's transvaginal mesh product. for the Southern District of West Virginia. Do You Have A Transvaginal Mesh Patch Claim? If you or a loved one has been injured by the transvaginal mesh device, you may want to speak with a personal injury attorney regarding a potential claim. A lawyer familiar with new developments in the investigation of transvaginal mesh may be able to help you make important personal and legal decisions. d'Oliveira & Associates is working with some of the leading medical device lawyers in the country who are handling these cases.

Transvaginal Mesh Infographic Patch

shared by DietKart on Jun 21
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Statistical data has shown that over 250,000 procedures take place annually. There are over 150 different transvaginal mesh devices marketed and sold each year. While estimates show that 10% of patie...

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