Rose, Klein & Marias LLP Rose, Klein & Marias LLP ROSE, KLEIN & MARIAS LLP

Mesh implants for women may have to undergo additional testing

Surgical mesh implants used to hold women's pelvic organs in place have been singled out by federal regulators for new safety studies. The Food and Drug Administration has received more than 1,500 complications reports that led to problems including infection and erosion.

Potentially thousands of women might be affected by the government's ruling in this product liability case. The devices in question are implanted when it becomes necessary to repair damage or weakened tissue, and to provide internal support for sufferers of pelvic organ prolapse, or POP. Another use is to aid women who suffer from stress urinary incontinence, or a severe overactive bladder.

As many as 50 percent of women may have POP in their lifetime, and about two percent will develop symptoms. Surgery aimed at supporting the prolapsed organs can be done with stitches or, increasingly in recent years, with surgical mesh.

The mesh treatment has been used in surgical applications for more than 50 years, and when companies began to manufacture it specifically for use in addressing POP and stress urinary incontinence, they did not have to do clinical trials in people. The requirement at the time was that the new devices had to be shown to be similar to items already on the market.

The FDA, however, is now reconsidering that notion and might reclassify the devices into a higher-risk group that would require clinical trials. This could affect thousands of women in California who might be in line to receive the devices, or have already received them. Anyone concerned with the effects of a potentially dangerous product may wish to contact an attorney to review their options.

Source: Reuters, "FDA wants new studies on surgical mesh impacts," Anna Yukhananov, Jan. 5, 2011

No Comments

Leave a comment
Comment Information

You Only Pay If We Win

Bold labels are required.

Contact Information

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.


Privacy Policy

10 Office Locations In Southern California

Southern California is large, but you should not be required to drive for hours to meet an experienced lawyer to help you with your case. Our law firm offers convenient locations in Los Angeles, Cerritos, Ontario, San Diego, Ventura, Encino, Gardena, Glendale, Orange and Valencia. We can also come to you.

Our Office Locations

Schedule your free consultation:

  • Los Angeles: 213-784-2801
  • Cerritos: 562-606-0348
  • Ontario: 909-581-9476
  • San Diego: 619-677-1431
  • Ventura: 805-290-4882

Our Firm Affiliations:

Mesh implants for women may have to undergo additional testing | Rose, Klein & Marias, LLP