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Shezad Malik MD JD
Attorney • (888) 210-9693

Australia bans Vaginal Mesh products as ‘too risky’

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Australia bans Vaginal Mesh products as ‘too risky’ according to a report in the Guardian newspaper.

Australia bans vaginal mesh products as 'too risky'

Transvaginal mesh medical products used by surgeons to treat pelvic organ prolapse and stress urinary incontinence have been banned by Australia’s government medical devices regulator.

Transvaginal mesh medical products used by surgeons to treat pelvic organ prolapse and stress urinary incontinence have been banned by Australia’s government medical devices regulator.

The Therapeutic Goods Administration (TGA) has determined that the products are too risky after a review of international studies and an examination of the clinical evidence for each product supplied in Australia.

According to the TGA, “Based on this new information, and since the publication by the TGA of the results of review into urogynaecological surgical mesh implants, the TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients.”

UK moves to ban Vaginal Mesh products

The UK’s health watchdog, the National Institute for Health and Care Excellence, has recommended vaginal mesh operations to treat prolapse should be banned as a routine treatment in England.

U.S. More than 100,000 injured women nationwide

More than 100,000 defective product liability and personal injury lawsuits have been filed by injured women against AMS/Endo and other major manufacturers of transvaginal mesh products, including Bard, Boston Scientific, Coloplast, and Johnson and Johnson.

Vaginal Mesh Injury Lawsuits

The majority of mesh injury cases have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, with the cases centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.

Seven different MDLs are currently centralized before Judge Goodwin, including those made by Bard, AMS, Boston Scientific, Ethicon, Coloplast, Neomedic and Cook Surgisis Biodesign mesh lawsuits.

J&J, said in SEC filings in February that it was defending 54,800 cases over its mesh implants, while Boston Scientific said it faced 43,000 mesh claims. Both companies have settled some mesh suits. The mesh implants have generated billions of dollars in profits for these companies.

Vaginal Mesh made from polypropylene plastic

Over the past 15 years, the vaginal mesh has been used for the repair of pelvic organ prolapse and female stress urinary incontinence. Serious design defects have been associated with surgical mesh which is made from non-absorbable polypropylene plastic and the mesh manufacturers were warned that the material was not safe to be used in humans.

The plastic mesh is linked to major side effects in women, in some cases, the injuries were catastrophic, including recurrent pelvic and bladder infections, erosion of the mesh into the vagina and other vital organs.

AMS-Endo Vaginal Mesh lawsuit final settlement

In 2014, Endo was the first major mesh and bladder sling manufacturer to settle mesh injury claims. The company initially agreed to pay about $830 million in AMS vaginal mesh settlements, then in August 2015, the company announced it added $1.53 billion for litigation and settlement costs, and then later tossed in another $834 million for vaginal mesh litigation.

Endo announced this summer, that an additional $775 million will be set aside to resolve another 22,000 mesh claims. Endo hopes that this final settlement will resolve all known claims, but Endo admits that it is possible further injury claims may be filed.

FDA “No benefit from Vaginal Mesh”

The FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products.

The FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.

In 2012, the FDA notified the mesh manufacturers that they undertake medical studies to determine the safety of transvaginal mesh products, and establish whether they have an unreasonable risk of injury for women. In 2016, the FDA labeled the vaginal mesh devices as “HIGH RISK.”

If you think you may have a Vaginal Mesh or bladder sling and are experiencing pain, recurrent infections, perforation caused by mesh erosion or have suffered a full revision and emergency care, please call Dr. Shezad Malik Law Firm at 888-210-9693.

1 Comment

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  1. Rosemary Rice says:
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    I have had a mesh implant for urinary stress incontinence many years ago. I have had a recent kidney transplant and since I have had many ongoing septic events with urosepsis which cant seem to be irradicated. Bladder and ureter are not the site of infection. Continued feeling of drag.

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