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Archive for the ‘MEDICAL DEVICES’ Category

Transvaginal Mesh Lawsuits Being Filed All Over US

Posted by elderlawyers on October 10, 2011

Have you heard about the number of transvaginal mesh lawsuits being filed all over the US? The lawyers at Burke, Harvey & Frankowski represent women who were not given options other than the transvaginal mesh (TVM) for pelvic organ prolapse (POP) or fallen bladder and are now suffering serious physical injuries.  Women are angry because they trusted their doctors in agreeing to have the mesh sling system procedure to support their pelvic organs, but have since learned of scientific studies that have raised concerns about the safety of transvaginal mesh procedures.  For example, one study by the Society of Obstetrician and Gynaecologists of Canada made the following 5 recommendations:

1. Patients should be counseled that transvaginal mesh procedures are considered novel techniques for pelvic floor repair that demonstrate high rates of anatomical cure in uncontrolled short-term case series.  (II-2B)

2. Patients should be informed of the range of success rates until stronger evidence of superiority is published.  (II-2B)

3. Training specific to transvaginal mesh procedures should be undertaken before procedures are performed.  (III-C)

4.Patients should undergo thorough pre-operative counseling regarding (a) the potential serious adverse sequelae of transvaginal mesh repairs, including mesh exposure, pain, and dyspareunia; and (b) the limited data available comparing transvaginal mesh systems with traditional vaginal prolapse repairs or with traditional use of graft material in the form of augmented colporrhaphy and sacral colpopexy.  (III-C)

5. Until appropriate supportive data are available, new trocarless kits should be considered investigative. (III-C)

Click here to read the full transvaginal mesh study.  Women are now finding studies that do not advocate the use of TVM or other types of bladder slings after they have already had the procedure.  Unfortunately, the women are finding the studies after they had the transvaginal mesh procedure and are experiencing auto-immune problems, decreased sex drive, infections, chronic bladder problems, and illness that they did not have before the surgery.  What now?  Some clients are seeing their OB/GYN to learn their options, including removal of the mesh.  Of course, that will mean more time off from work and another recovery period.

Want to learn what legal options you have?  Contact medical device lawyer Todd Harvey online or by calling Burke, Harvey and Frankowski at 1-888-930-9091 for a free legal consultation.  Our lawyers are licensed in Alabama, Florida, Georgia, Mississippi, Tennessee, Texas and New York.  We also have a national network of referral lawyers to help you anywhere in the US.

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FDA SAYS SURGICAL MESH USED TO REPAIR PELVIC ORGAN PROLAPSE POSES RISK

Posted by elderlawyers on July 28, 2011

Burke, Harvey and Frankowski represents clients who have been seriously injured by medical devices, including devices used to treat pelvic organ prolapse (POP). What is pelvic organ prolapse? Pelvic organ prolapse is a medical condition that occurs when the internal support structure of the vagina fails.  Transvaginal mesh surgery, also called TVM, is used to treat thousands of women every year for POP.  For example, in 2010 alone, over 75,000 women had transvaginal mesh surgery.

The transvaginal mesh is used to keep the urethra, cervix, bladder neck and rectum from falling out-of-place inside the body activity.  Most POP patients are treated with a transvaginal mesh.

Recent studies of the transvaginal mesh medical devices indicate an association with higher rates of serious complications, such as bladder perforation and pelvic hemorrhage.  In fact, the Food and Drug Administration (FDA) recently found no evidence that the transvaginal mesh provides patients with any added benefit compared to traditional surgery where the vaginal wall is stitched.  Read the FDA press release HERE.  Read the FDA’s alert notice regarding transvaginal meshes HERE.

Burke, Harvey & Frankowski is investigating and evaluating pelvic organ prolapse (POP) and stress urinary incontinence
(SUI) transvaginal mesh failure cases. Attorney Todd Harvey is heading the litigation for the firm.  Contact Mr. Harvey for a free legal consultation.

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