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Vaginal Mesh Infographic

Vaginal Mesh: Causing Thousands of Women Pain Many of the vaginal mesh products on the market today were approved based on their similarity to products that were taken off the market for safety reasons. HOW WAS THIS ALLOWED ТО НАРРЕN? ....... 2009 2010 2007 2005 ...... JAN 05 DEC 10 1 | 31 Between Jan. 1, 2005, and Dec. 31, 2010, the FDA received 2,874 reports of adverse events in connection with all urogynecologic mesh products 1,503 reports were related to the use of surgical 1,371 reports 00 124 reported vaginal were related to the use of mesh to treat pelvic organ prolapse. surgical mesh to treat stress bleeding urinary incontinence. In 2010... 16% C0 253 of them reported infection 31% O 472 of them reported pain 260.000 women underwent surgical procedures to treat stress urinary incontinence. 80% of surgeries to treat stress urinary incontinence were performed by implanting surgical mesh through incisions in the vagina. women underwent 300,000 surgical procedures to repair pelvic organ prolapse. 75,000 of them had surgical mesh implanted through incisions in the vagina to treat pelvic organ prolapse. Source: FDA Executive Summary "Surgical Mesh for Treatment of Women With Pelvic Organ Prolapse and Stress Urinary Incontinence" (prepared for the Obstetrics & Gynecology Devices Advisory Committee meeting on Sept. 8-9, 2011) MANY MESH PRODUCTS WERE BASED ON THE PROTEGEN SLING, WHICH WAS RECALLED. 1996 1998 2003 1999 Boston Scientific's ProteGen Sling gets FDA approval. Recalled by the manufacturer for safety An American Medical Systems vaginal mesh product gets approval based on its similarity to the ProteGen Sling. reasons Mentor Corp.'s ObTape vaginal mesh product gets FDA approval based on its similarity to J&J's tension-free vaginal tape. Johnson & Johnson's Gynecare TVT gets FDA approval based on its similarity to the Protegen Sling. Coviden vaginal mesh product gets FDA approval based on its similarity to the ProteGen Sling. A History of the Problem 1996 1998 1999 2003 2004 Based on their similarity to the ProteGen Sling, the FDA clears: Johnson & Johnson's Gynecare TVT vaginal mesh product, an American Medical Systems vaginal mesh product, a Coviden vaginal mesh product. Boston Scientific voluntarily recalls the ProteGen Sling after having received 123 reports of problems. The first of 266 FDA approves Boston Scientific's ProteGen Sling, the first vaginally implanted mesh designed specifically to treat incontinence. Mentor Corporation's ObTape hits the market. Boston Scientific settles reports of complications related to ObTape start pouring in to the FDA. 738 lawsuits over its mesh products for an undisclosed sum. 2006 2008 2010 2011 2012 Approximately 300,000 women receive vaginal mesh implants. Members of Congress introduce a bill to prevent medical devices from being approved based solely on their similarity to devices that once got FDA approval but have since been taken off the market. The FDA issues a The FDA announces that "serious complications associated with surgical mesh for transvaginal repair of female pelvic organ prolapse are not rare. - An FDA advisory panel recommends some vaginal meshes be reclassified as high-risk devices requiring new studies to stay on the market, but the FDA takes no further formal action. Mentor Corporation discontinues ObTape. warning stating that mesh-related complications are "serious, but rare." The FDA receives another 2,900 reports of serious complications from surgical mesh products implanted through the vagina. There are more than 600 lawsuits pending against several of the manufacturers of different vaginal-mesh-implant products, many of which-including J&J's Gynecare TVT-remain on the market. www.vaginalmeshlawsuit.com | Rottenstein Law Group | Infographic designed by Martina Seefeld Vaginal Mesh: Causing Thousands of Women Pain Many of the vaginal mesh products on the market today were approved based on their similarity to products that were taken off the market for safety reasons. HOW WAS THIS ALLOWED ТО НАРРЕN? ....... 2009 2010 2007 2005 ...... JAN 05 DEC 10 1 | 31 Between Jan. 1, 2005, and Dec. 31, 2010, the FDA received 2,874 reports of adverse events in connection with all urogynecologic mesh products 1,503 reports were related to the use of surgical 1,371 reports 00 124 reported vaginal were related to the use of mesh to treat pelvic organ prolapse. surgical mesh to treat stress bleeding urinary incontinence. In 2010... 16% C0 253 of them reported infection 31% O 472 of them reported pain 260.000 women underwent surgical procedures to treat stress urinary incontinence. 80% of surgeries to treat stress urinary incontinence were performed by implanting surgical mesh through incisions in the vagina. women underwent 300,000 surgical procedures to repair pelvic organ prolapse. 75,000 of them had surgical mesh implanted through incisions in the vagina to treat pelvic organ prolapse. Source: FDA Executive Summary "Surgical Mesh for Treatment of Women With Pelvic Organ Prolapse and Stress Urinary Incontinence" (prepared for the Obstetrics & Gynecology Devices Advisory Committee meeting on Sept. 8-9, 2011) MANY MESH PRODUCTS WERE BASED ON THE PROTEGEN SLING, WHICH WAS RECALLED. 1996 1998 2003 1999 Boston Scientific's ProteGen Sling gets FDA approval. Recalled by the manufacturer for safety An American Medical Systems vaginal mesh product gets approval based on its similarity to the ProteGen Sling. reasons Mentor Corp.'s ObTape vaginal mesh product gets FDA approval based on its similarity to J&J's tension-free vaginal tape. Johnson & Johnson's Gynecare TVT gets FDA approval based on its similarity to the Protegen Sling. Coviden vaginal mesh product gets FDA approval based on its similarity to the ProteGen Sling. A History of the Problem 1996 1998 1999 2003 2004 Based on their similarity to the ProteGen Sling, the FDA clears: Johnson & Johnson's Gynecare TVT vaginal mesh product, an American Medical Systems vaginal mesh product, a Coviden vaginal mesh product. Boston Scientific voluntarily recalls the ProteGen Sling after having received 123 reports of problems. The first of 266 FDA approves Boston Scientific's ProteGen Sling, the first vaginally implanted mesh designed specifically to treat incontinence. Mentor Corporation's ObTape hits the market. Boston Scientific settles reports of complications related to ObTape start pouring in to the FDA. 738 lawsuits over its mesh products for an undisclosed sum. 2006 2008 2010 2011 2012 Approximately 300,000 women receive vaginal mesh implants. Members of Congress introduce a bill to prevent medical devices from being approved based solely on their similarity to devices that once got FDA approval but have since been taken off the market. The FDA issues a The FDA announces that "serious complications associated with surgical mesh for transvaginal repair of female pelvic organ prolapse are not rare. - An FDA advisory panel recommends some vaginal meshes be reclassified as high-risk devices requiring new studies to stay on the market, but the FDA takes no further formal action. Mentor Corporation discontinues ObTape. warning stating that mesh-related complications are "serious, but rare." The FDA receives another 2,900 reports of serious complications from surgical mesh products implanted through the vagina. There are more than 600 lawsuits pending against several of the manufacturers of different vaginal-mesh-implant products, many of which-including J&J's Gynecare TVT-remain on the market. www.vaginalmeshlawsuit.com | Rottenstein Law Group | Infographic designed by Martina Seefeld Vaginal Mesh: Causing Thousands of Women Pain Many of the vaginal mesh products on the market today were approved based on their similarity to products that were taken off the market for safety reasons. HOW WAS THIS ALLOWED ТО НАРРЕN? ....... 2009 2010 2007 2005 ...... JAN 05 DEC 10 1 | 31 Between Jan. 1, 2005, and Dec. 31, 2010, the FDA received 2,874 reports of adverse events in connection with all urogynecologic mesh products 1,503 reports were related to the use of surgical 1,371 reports 00 124 reported vaginal were related to the use of mesh to treat pelvic organ prolapse. surgical mesh to treat stress bleeding urinary incontinence. In 2010... 16% C0 253 of them reported infection 31% O 472 of them reported pain 260.000 women underwent surgical procedures to treat stress urinary incontinence. 80% of surgeries to treat stress urinary incontinence were performed by implanting surgical mesh through incisions in the vagina. women underwent 300,000 surgical procedures to repair pelvic organ prolapse. 75,000 of them had surgical mesh implanted through incisions in the vagina to treat pelvic organ prolapse. Source: FDA Executive Summary "Surgical Mesh for Treatment of Women With Pelvic Organ Prolapse and Stress Urinary Incontinence" (prepared for the Obstetrics & Gynecology Devices Advisory Committee meeting on Sept. 8-9, 2011) MANY MESH PRODUCTS WERE BASED ON THE PROTEGEN SLING, WHICH WAS RECALLED. 1996 1998 2003 1999 Boston Scientific's ProteGen Sling gets FDA approval. Recalled by the manufacturer for safety An American Medical Systems vaginal mesh product gets approval based on its similarity to the ProteGen Sling. reasons Mentor Corp.'s ObTape vaginal mesh product gets FDA approval based on its similarity to J&J's tension-free vaginal tape. Johnson & Johnson's Gynecare TVT gets FDA approval based on its similarity to the Protegen Sling. Coviden vaginal mesh product gets FDA approval based on its similarity to the ProteGen Sling. A History of the Problem 1996 1998 1999 2003 2004 Based on their similarity to the ProteGen Sling, the FDA clears: Johnson & Johnson's Gynecare TVT vaginal mesh product, an American Medical Systems vaginal mesh product, a Coviden vaginal mesh product. Boston Scientific voluntarily recalls the ProteGen Sling after having received 123 reports of problems. The first of 266 FDA approves Boston Scientific's ProteGen Sling, the first vaginally implanted mesh designed specifically to treat incontinence. Mentor Corporation's ObTape hits the market. Boston Scientific settles reports of complications related to ObTape start pouring in to the FDA. 738 lawsuits over its mesh products for an undisclosed sum. 2006 2008 2010 2011 2012 Approximately 300,000 women receive vaginal mesh implants. Members of Congress introduce a bill to prevent medical devices from being approved based solely on their similarity to devices that once got FDA approval but have since been taken off the market. The FDA issues a The FDA announces that "serious complications associated with surgical mesh for transvaginal repair of female pelvic organ prolapse are not rare. - An FDA advisory panel recommends some vaginal meshes be reclassified as high-risk devices requiring new studies to stay on the market, but the FDA takes no further formal action. Mentor Corporation discontinues ObTape. warning stating that mesh-related complications are "serious, but rare." The FDA receives another 2,900 reports of serious complications from surgical mesh products implanted through the vagina. There are more than 600 lawsuits pending against several of the manufacturers of different vaginal-mesh-implant products, many of which-including J&J's Gynecare TVT-remain on the market. www.vaginalmeshlawsuit.com | Rottenstein Law Group | Infographic designed by Martina Seefeld Vaginal Mesh: Causing Thousands of Women Pain Many of the vaginal mesh products on the market today were approved based on their similarity to products that were taken off the market for safety reasons. HOW WAS THIS ALLOWED ТО НАРРЕN? ....... 2009 2010 2007 2005 ...... JAN 05 DEC 10 1 | 31 Between Jan. 1, 2005, and Dec. 31, 2010, the FDA received 2,874 reports of adverse events in connection with all urogynecologic mesh products 1,503 reports were related to the use of surgical 1,371 reports 00 124 reported vaginal were related to the use of mesh to treat pelvic organ prolapse. surgical mesh to treat stress bleeding urinary incontinence. In 2010... 16% C0 253 of them reported infection 31% O 472 of them reported pain 260.000 women underwent surgical procedures to treat stress urinary incontinence. 80% of surgeries to treat stress urinary incontinence were performed by implanting surgical mesh through incisions in the vagina. women underwent 300,000 surgical procedures to repair pelvic organ prolapse. 75,000 of them had surgical mesh implanted through incisions in the vagina to treat pelvic organ prolapse. Source: FDA Executive Summary "Surgical Mesh for Treatment of Women With Pelvic Organ Prolapse and Stress Urinary Incontinence" (prepared for the Obstetrics & Gynecology Devices Advisory Committee meeting on Sept. 8-9, 2011) MANY MESH PRODUCTS WERE BASED ON THE PROTEGEN SLING, WHICH WAS RECALLED. 1996 1998 2003 1999 Boston Scientific's ProteGen Sling gets FDA approval. Recalled by the manufacturer for safety An American Medical Systems vaginal mesh product gets approval based on its similarity to the ProteGen Sling. reasons Mentor Corp.'s ObTape vaginal mesh product gets FDA approval based on its similarity to J&J's tension-free vaginal tape. Johnson & Johnson's Gynecare TVT gets FDA approval based on its similarity to the Protegen Sling. Coviden vaginal mesh product gets FDA approval based on its similarity to the ProteGen Sling. A History of the Problem 1996 1998 1999 2003 2004 Based on their similarity to the ProteGen Sling, the FDA clears: Johnson & Johnson's Gynecare TVT vaginal mesh product, an American Medical Systems vaginal mesh product, a Coviden vaginal mesh product. Boston Scientific voluntarily recalls the ProteGen Sling after having received 123 reports of problems. The first of 266 FDA approves Boston Scientific's ProteGen Sling, the first vaginally implanted mesh designed specifically to treat incontinence. Mentor Corporation's ObTape hits the market. Boston Scientific settles reports of complications related to ObTape start pouring in to the FDA. 738 lawsuits over its mesh products for an undisclosed sum. 2006 2008 2010 2011 2012 Approximately 300,000 women receive vaginal mesh implants. Members of Congress introduce a bill to prevent medical devices from being approved based solely on their similarity to devices that once got FDA approval but have since been taken off the market. The FDA issues a The FDA announces that "serious complications associated with surgical mesh for transvaginal repair of female pelvic organ prolapse are not rare. - An FDA advisory panel recommends some vaginal meshes be reclassified as high-risk devices requiring new studies to stay on the market, but the FDA takes no further formal action. Mentor Corporation discontinues ObTape. warning stating that mesh-related complications are "serious, but rare." The FDA receives another 2,900 reports of serious complications from surgical mesh products implanted through the vagina. There are more than 600 lawsuits pending against several of the manufacturers of different vaginal-mesh-implant products, many of which-including J&J's Gynecare TVT-remain on the market. www.vaginalmeshlawsuit.com | Rottenstein Law Group | Infographic designed by Martina Seefeld Vaginal Mesh: Causing Thousands of Women Pain Many of the vaginal mesh products on the market today were approved based on their similarity to products that were taken off the market for safety reasons. HOW WAS THIS ALLOWED ТО НАРРЕN? ....... 2009 2010 2007 2005 ...... JAN 05 DEC 10 1 | 31 Between Jan. 1, 2005, and Dec. 31, 2010, the FDA received 2,874 reports of adverse events in connection with all urogynecologic mesh products 1,503 reports were related to the use of surgical 1,371 reports 00 124 reported vaginal were related to the use of mesh to treat pelvic organ prolapse. surgical mesh to treat stress bleeding urinary incontinence. In 2010... 16% C0 253 of them reported infection 31% O 472 of them reported pain 260.000 women underwent surgical procedures to treat stress urinary incontinence. 80% of surgeries to treat stress urinary incontinence were performed by implanting surgical mesh through incisions in the vagina. women underwent 300,000 surgical procedures to repair pelvic organ prolapse. 75,000 of them had surgical mesh implanted through incisions in the vagina to treat pelvic organ prolapse. Source: FDA Executive Summary "Surgical Mesh for Treatment of Women With Pelvic Organ Prolapse and Stress Urinary Incontinence" (prepared for the Obstetrics & Gynecology Devices Advisory Committee meeting on Sept. 8-9, 2011) MANY MESH PRODUCTS WERE BASED ON THE PROTEGEN SLING, WHICH WAS RECALLED. 1996 1998 2003 1999 Boston Scientific's ProteGen Sling gets FDA approval. Recalled by the manufacturer for safety An American Medical Systems vaginal mesh product gets approval based on its similarity to the ProteGen Sling. reasons Mentor Corp.'s ObTape vaginal mesh product gets FDA approval based on its similarity to J&J's tension-free vaginal tape. Johnson & Johnson's Gynecare TVT gets FDA approval based on its similarity to the Protegen Sling. Coviden vaginal mesh product gets FDA approval based on its similarity to the ProteGen Sling. A History of the Problem 1996 1998 1999 2003 2004 Based on their similarity to the ProteGen Sling, the FDA clears: Johnson & Johnson's Gynecare TVT vaginal mesh product, an American Medical Systems vaginal mesh product, a Coviden vaginal mesh product. Boston Scientific voluntarily recalls the ProteGen Sling after having received 123 reports of problems. The first of 266 FDA approves Boston Scientific's ProteGen Sling, the first vaginally implanted mesh designed specifically to treat incontinence. Mentor Corporation's ObTape hits the market. Boston Scientific settles reports of complications related to ObTape start pouring in to the FDA. 738 lawsuits over its mesh products for an undisclosed sum. 2006 2008 2010 2011 2012 Approximately 300,000 women receive vaginal mesh implants. Members of Congress introduce a bill to prevent medical devices from being approved based solely on their similarity to devices that once got FDA approval but have since been taken off the market. The FDA issues a The FDA announces that "serious complications associated with surgical mesh for transvaginal repair of female pelvic organ prolapse are not rare. - An FDA advisory panel recommends some vaginal meshes be reclassified as high-risk devices requiring new studies to stay on the market, but the FDA takes no further formal action. Mentor Corporation discontinues ObTape. warning stating that mesh-related complications are "serious, but rare." The FDA receives another 2,900 reports of serious complications from surgical mesh products implanted through the vagina. There are more than 600 lawsuits pending against several of the manufacturers of different vaginal-mesh-implant products, many of which-including J&J's Gynecare TVT-remain on the market. www.vaginalmeshlawsuit.com | Rottenstein Law Group | Infographic designed by Martina Seefeld Vaginal Mesh: Causing Thousands of Women Pain Many of the vaginal mesh products on the market today were approved based on their similarity to products that were taken off the market for safety reasons. HOW WAS THIS ALLOWED ТО НАРРЕN? ....... 2009 2010 2007 2005 ...... JAN 05 DEC 10 1 | 31 Between Jan. 1, 2005, and Dec. 31, 2010, the FDA received 2,874 reports of adverse events in connection with all urogynecologic mesh products 1,503 reports were related to the use of surgical 1,371 reports 00 124 reported vaginal were related to the use of mesh to treat pelvic organ prolapse. surgical mesh to treat stress bleeding urinary incontinence. In 2010... 16% C0 253 of them reported infection 31% O 472 of them reported pain 260.000 women underwent surgical procedures to treat stress urinary incontinence. 80% of surgeries to treat stress urinary incontinence were performed by implanting surgical mesh through incisions in the vagina. women underwent 300,000 surgical procedures to repair pelvic organ prolapse. 75,000 of them had surgical mesh implanted through incisions in the vagina to treat pelvic organ prolapse. Source: FDA Executive Summary "Surgical Mesh for Treatment of Women With Pelvic Organ Prolapse and Stress Urinary Incontinence" (prepared for the Obstetrics & Gynecology Devices Advisory Committee meeting on Sept. 8-9, 2011) MANY MESH PRODUCTS WERE BASED ON THE PROTEGEN SLING, WHICH WAS RECALLED. 1996 1998 2003 1999 Boston Scientific's ProteGen Sling gets FDA approval. Recalled by the manufacturer for safety An American Medical Systems vaginal mesh product gets approval based on its similarity to the ProteGen Sling. reasons Mentor Corp.'s ObTape vaginal mesh product gets FDA approval based on its similarity to J&J's tension-free vaginal tape. Johnson & Johnson's Gynecare TVT gets FDA approval based on its similarity to the Protegen Sling. Coviden vaginal mesh product gets FDA approval based on its similarity to the ProteGen Sling. A History of the Problem 1996 1998 1999 2003 2004 Based on their similarity to the ProteGen Sling, the FDA clears: Johnson & Johnson's Gynecare TVT vaginal mesh product, an American Medical Systems vaginal mesh product, a Coviden vaginal mesh product. Boston Scientific voluntarily recalls the ProteGen Sling after having received 123 reports of problems. The first of 266 FDA approves Boston Scientific's ProteGen Sling, the first vaginally implanted mesh designed specifically to treat incontinence. Mentor Corporation's ObTape hits the market. Boston Scientific settles reports of complications related to ObTape start pouring in to the FDA. 738 lawsuits over its mesh products for an undisclosed sum. 2006 2008 2010 2011 2012 Approximately 300,000 women receive vaginal mesh implants. Members of Congress introduce a bill to prevent medical devices from being approved based solely on their similarity to devices that once got FDA approval but have since been taken off the market. The FDA issues a The FDA announces that "serious complications associated with surgical mesh for transvaginal repair of female pelvic organ prolapse are not rare. - An FDA advisory panel recommends some vaginal meshes be reclassified as high-risk devices requiring new studies to stay on the market, but the FDA takes no further formal action. Mentor Corporation discontinues ObTape. warning stating that mesh-related complications are "serious, but rare." The FDA receives another 2,900 reports of serious complications from surgical mesh products implanted through the vagina. There are more than 600 lawsuits pending against several of the manufacturers of different vaginal-mesh-implant products, many of which-including J&J's Gynecare TVT-remain on the market. www.vaginalmeshlawsuit.com | Rottenstein Law Group | Infographic designed by Martina Seefeld

Vaginal Mesh Infographic

shared by rotlawgroup on Mar 20
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The infographic—viewable at http://www.vaginalmeshlawsuit.com/vaginal-mesh-infographic/ —clearly and succinctly illustrates how several vaginal mesh products, all of which became the subject of hu...

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Martina Seefeld

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