Transvaginal Mesh Recall, Requested by Public Citizen

Public advocacy group, Public Citizen, has just petitioned the FDA to ban all surgical mesh products for use in transvaginal repair procedures and for the manufactures to recall their products on the market today.   Public Citizen claims that these mesh devices expose patients to unnecessary risk without providing benefits above and beyond safer alternatives.

Public Citizen claims that about 75,000 women had prolapse surgery last year that involved some form of mesh implant.  Public Citizen's Dr. Michael Carome is quoted as saying,"Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately."

This is true.  Last month, the FDA made harsh statements against these products and advised against using them.  Deputy director and chief scientist of the FDA's Center for Devices and Radiological Health, Dr. William Maisel, "There are clear risks associated with the transvaginal placement of mesh to treat POP." 

The timing of this recall request is notable, as advisory panel members of the FDA plan to meet on September 8th to further discuss the efficacy and safety of such mesh devices. 

Mesh erosion is the most commonly reported problem associated with transvaginally implanted mesh devices and can cause considerable pain and discomfort as well as bleeding and infection.

Alabama Lawsuit Filed Against Vaginal Mesh MFGs.

An Alabama woman recently filed a product liability lawsuit against vaginal mesh manufacturers Boston Scientific and American Medical Systems (AMS).  She originally sought vaginal mesh implantation to treat pelvic organ prolapse (POP) and stress urinary incontinence. 

Specifically, the devices named in the lawsuit are the Elevate Anterior & Apical mesh systems by AMS and the Pinnacle Posterior Pelvic Floor Repair Kit & Solyx SIS System by Boston Scientific.

Allegations surrounding these and similar mesh implant products (primarily those that were surgically implanted transvaginally) all suggest the same thing – that the mesh products were defective and that the manufactures knowingly kept selling and marketing these products despite their unnatural rate of failure.

The FDA just recently made statements warning of the risks of vaginal mesh implants and advised against having these products implanted.  Advisory panel members of the FDA plan to meet on September 8^th to further discuss the efficacy and safety of such devices.

When seeking recovery from companies that caused injuries, especially in product liability cases, it is important to contact a knowledgeable and experienced attorney.  It is important that you contact a vaginal mesh lawyer that will not make you part of a class action lawsuit; one that will give you the attention that your individualized situation requires.

Symptoms of Pelvic Organ Prolapse

Symptoms of Pelvic Organ Prolapse (POP) include all or some of the following:

• A feeling of pressure from pelvic organs pressing against vaginal walls.  This is the most common symptom.
• Incontinence - the uncontrollable release of urine and/or frequently having the need to urinate.
• A feeling of fullness in your lower abdominal region.
•  Pain in your lower back or groin area.
• Painful intercourse.  This can actually occur for both partners, especially if the mesh implant has started eroding.
• Constipation. 
• A feeling of something falling out of your vagina.

If you think you have a pelvic organ prolapse, it is critical that you visit your gynecologist or general physician as soon as possible.