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Drugs & Medical Devices Pelvic Mesh

2008 Advisory

in this section: Warnings | 2012 FDA Scrutiny | Medical opinions on pelvic mesh dangers | 2008 Advisory | Letter to Doctors


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Transvaginal Surgical Mesh Patch May Cause Serious Injury

On October 21, 2008, the U.S. Food and Drug Administration (FDA) issued the following alert about women who experienced serious complications after undergoing gynecological or pelvic organ prolapse surgery. The use of the Gynecare transvaginal surgical mesh patch system has been linked to patient injury, scarring and other serious health problems.

Our attorneys are currently investigating this issue, and would like to speak with women who suffered pelvic organ damage after undergoing surgery involving transvaginal mesh.

Audience: Hospital surgical staff, OB/GYN physicians, other healthcare professionals

FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.

There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks.

Get Information and Help from an Experienced Lawyer
If you or a loved one has experienced a serious injury after undergoing bladder or gynecological surgery that may be caused by the Gynecare surgical mesh system, our lawyers may be able to help you to seek compensation for your injury, pain and suffering, and other money to help with bills and other expenses.

Please complete the form on this page for a free and confidential review of your potential lawsuit. A Weitz & Luxenberg representative will contact you as soon as possible.

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Please complete the following questionnaire:

First Name
Last Name
City/State
E-mail address
Date of initial implant surgery:
Brand Name of product initially implanted:
What type of device were you implanted with? Ethicon
Johnson & Johnson
Prolene Mesh
Gynemesh
TVT
TVT-O
TVT-S
Prolift
Prolift + M
Gynecare Pelvic Mesh Product(s)
C. R. Bard
Avaulta Anterior and Posterior BioSynthetic Support Systems
Date of initial complications:
Please describe the nature of your injury:
Do you smoke? Yes
Phone number (Optional)


see also:

Warnings Warnings about Gynecare TVT Mesh | Weitz & Luxenberg attorneys
Gynecare TVT mesh has been linked to serious post-surgical complications in women. Those affected can get a free lawsuit review from Weitz & Luxenberg

Medical opinions on pelvic mesh dangers Medical opinions on pelvic mesh dangers


FDA News Transvaginal Mesh Patch Injuries | Weitz & Luxenberg Attorneys
Free defective medical device lawsuit is available for women who were injured after receiving a transvaginal mesh patch during pelvic organ surgery.

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