Arias Ozzello & Gignac LLP

We Handle Cases throughout the United States

800-475-2570

Navigation

FDA Strengthens Its Focus on Surgical Mesh

Last week, the New York Times reported that the FDA ordered the manufacturers of surgical mesh used in women to treat urinary incontinence or pelvic organ prolapse to study its risks. This order comes after a recent warning in July about the adverse side effects and severe complications following implantation of the mesh device.

The FDA issued an earlier warning against this device in 2008 but said that complications were rare. Since then, however, it has been discovered through a study of these devices that nearly 15% of the 185,000 women implanted with the surgical mesh have experienced complications such as infection, erosion of the mesh, hardening of the mesh, and numerous other painful complications. This same study yielded results that determined the surgical mesh devices provided no greater benefit than other forms of treatment.

It is unclear, however, whether this order will yield any results or change the design of the device. In May, over 8 months ago, the FDA issued a similar order to the manufacturers of all-metal hip implants. Yet in these past eight months, it has been reported that manufacturers are still discussing the design, not the design defects. Many are hopeful that design studies of the mesh devices will advance much more quickly than the hip studies. Many doctors are prompting for a recall of this device, and maybe the FDA order will be the first step.

Proudly serving Los Angeles area, throughout California and nationwide. Including residents of Long Beach, Torrance, Anaheim, Santa Ana, Huntington Beach, San Bernardino, Palm Springs, Riverside, Orange, Ventura, Santa Barbara, Fresno, Bakersfield, Stockton, Chula Vista, Irvine, Glendale, Modesto, Oxnard, Oceanside, Santa Clarita, Ontario, Pomona, Malibu, Beverly Hills, Hollywood, South Bay, San Diego, San Francisco, Sacramento, Oakland, San Jose, Los Angeles County, Orange County, Riverside County, San Bernardino County, Ventura County, San Diego County, Alameda County, San Francisco County, Kern County, Santa Barbara County, Sacramento County, Santa Clara County, and Contra Costa County.  Search Engine Optimization by Omnipresent SEO