Rose, Klein & Marias LLP
Select An Office To Call Now
  • Los Angeles: 213-784-2801
  • Cerritos: 562-606-0348
  • Ontario: 909-581-9476
  • San Diego: 619-677-1431
  • Ventura: 805-290-4882

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
Schedule Your Free Consultation

You Only Pay If We Win: Contact Us Today

Complete the form below to schedule a free initial consultation.

Bold labels are required.

Contact Information
disclaimer.

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.

close

Privacy Policy

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

View all locations

Firm Affiliations:

  • AMERICAN ASSOCIATION FOR JUSTICE || LEADERS FORUM