Transvaginal Mesh Lawsuit Information

…did the FDA fail women?...

What Is Transvaginal Mesh?

Transvaginal Mesh:

It’s a net-like implant used to treat pelvic organ prolapse (POP) and stress urinary incontinence in women.

POP occurs when…The tissue and muscles of the pelvic floor no longer support the pelvic organs resulting in the drop (prolapse) of the pelvic organs from their normal position.

Source: FDA “Urogynecologic Surgical Mesh Implants”

Surgical MeshComplications?

Some of the documented surgical mesh side effects:

• excessive bleeding• chronic back pain• bloating• pain during intercourse• urinary problems

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The side effects above may indicate:

• mesh erosion• infection• organ perforation

FDA Record…?

• 1996 - Transvaginal mesh products were first cleared by the FDA (the first by Boston Scientific called the ProteGen vaginal sling)

• According to the American Journal of Obstetrics & Gynecology (AJOG)

Continued >>

• The initial device was later recalled in 1999 by Boston Scientific, but related products from other manufacturers were still being used.

• 2014 – FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse

• 2016 – FDA is reclassifying these devices from class II to class III.

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Additional Studies?

• “Complication and Reoperation Rates After Apical Prolapse Surgical Repair” (study)

• “Mesh-Related Infections After Pelvic Organ Prolapse Repair Surgery”

• “Vaginal Mesh for Prolapse: A Randomized Controlled Trial” and more…

Source: http://journals.lww.com/greenjournal/Abstract/2009/02000/Complication_and_Reoperation_Rates_After_Apical.19.aspx

Verdicts and Settlements?

• Deborah Barba’s Verdict - $100 Million (against Boston Scientific for its Pinnacle and Advantage Fit mesh products).

• Colleen Perry’s Verdict - $5.7 Million (against Johnson & Johnson’s Ethicon brand over its Abbrevo Sling mesh product)

• Martha Salazar’s Verdict - $73.4 Million (against Boston Scientific)

• To name just a few…

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…increasing numbers of lawsuit claims being filed every day...

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If you have suffered complications or injuries resulting from a mesh implant, contact us immediately to get

more information about your legal rights.

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