This FDA’s January 4th action of reclassifying the surgical mesh devices as High Risk follows on years of advisory panels and post market surveillance looking into the risk of pelvic organ prolapse (POP) repair with surgical mesh devices.
The FDA is additionally requiring manufacturers to document product safety and effectiveness through a premarket approval (PMA). Manufacturers including Ethicon (a subsidiary of Johnson& Johnson), Boston Scientific Corp and C.R. Bard have 30 months to comply for devices already on the market and a preapproval of any new devices before they could be marketed
While surgical mesh has been used to repair abdominal hernias since the 1950s and in pelvic organ prolapse repair since the 1970s, a significant reporting of adverse events involving the surgical mesh has been noticed in recent years. The FDA issued warnings about risks including:
· Urinary problems
· Organ perforation
· Pain during intercourse
· Pelvic pain
· Bleeding; and
At the core of these issues are how these devices have been marketed and whether the risks have been adequately communicated or explained or as some allege even concealed from the public. The reclassification has been proposed since April of 2014. This risk reclassification, along with recent lawsuit settlements are beginning to create a clearer picture of the risks and marketing tactics actually employed
Lawsuit Decisions against Surgical Mesh Manufacturers
Last month, a lawsuit went before a jury pitting Ethicon/J&J against Patricia Hammons, a Wal-Mart stocker from Indiana. She had an Ethicon pelvic mesh barrier device implanted in 2009 to address sagging. In one interesting bit of testimony, a J&J product engineer alluded to the company not giving much thought to removing the mesh if it failed
One of Many TVM Cases?
To date there have been 16 verdicts against pelvic mesh manufacturers, with thousands waiting to be heard. Recent case results totaling $247 Million include:
· $100 million in May of 2015 in one case against Boston Scientific
· In March of 2015 Ethicon (J&J) paid out 5.7 Million to woman in California
Time will tell as these cases come to trial as to the extent of manufacturers’ liability. The outcomes may force a broader settlement or corporate response to the growing backlog of lawsuits. Contact a local experienced attorney if you have been affected by a TVM product to learn about your legal options.
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