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The FDA Bans Pelvic Surgical Mesh, and Hernia Mesh Could Soon Follow

Posted on 9th August, 2019

by Legal Staff

Did you have hernia mesh surgery and suffer complications? Then you should know there is little difference between the transvaginal mesh that has been recently banned in the US and the hernia mesh.

Hernia mesh has many similarities to the pelvic mesh including, in many cases, the same manufacturer, and hernia repair mesh could eventually be pulled from the US market.

Surgical mesh, whether it's used for pelvic organ prolapse and to treat stress urinary incontinence in women or for hernia repair, is usually made of polypropylene.

This is a chemical compound that originated from the oil industry and had all types of uses in the 1950s. In the 1970s, medical professionals began to use hernia mesh in gynecological cases.

Medical Device Safety

The FDA took a stricter stance on the FDA's 510 (k) fast track medical device's approval process. The FDA's 510 (k) fast-track process came under fire in the Netflix documentary "The Bleeding Edge" when Dr. David Kessler, former FDA commissioner, blew the whistle and exposed the process for the flaws therein.

The 510 (k) bypasses the rigors of strict human testing of a medical device in favor of rushing it to market if the manufacturer can prove that the device is substantially similar to one that is already on the market. The regulation fails to account for defective medical devices that have been recalled, or have been the subject of patient claims.

A medical device like the transvaginal mesh could have and probably did make it to market because it was shown to be similar to the hernia mesh.

Transvaginal Mesh: FDA Ordered Remaining Products off US Market

Due to the high rate of failure, the FDA reclassified the transvaginal mesh as high risk, forcing makers to resubmit their product for additional post-market approval testing before being once again approved for sale.

According to Evaluate.com, the only two companies that continued to sell pelvic mesh devices and had reapplied for FDA approval were both turned down, forced to immediately stop selling the devices, and to recall remaining transvaginal mesh devices.

Adverse Reactions to Hernia Mesh Implants

Regarding hernia mesh products, doctors and experts question their need given the number and extent of the problems the device has caused.

In the light of the many failures of hernia mesh, and Ethicon's voluntary market withdrawal of Physiomesh back in 2016 citing abnormally high failure rates, as well as the product's similarities to the failed and banned transvaginal mesh device.

Currently, individuals that have been harmed by defective hernia meshes are pursuing justice for their injuries. Bringing a hernia mesh claim is intended to compensate for medical expenses, loss of income, pain & suffering, and similar types of damages.

Do you qualify to bring a hernia mesh claim? Contact Atraxia Law today to see if you are eligible to receive compensation through a hernia mesh claim.