Skip to Main Content
Wexler Boley & Elgersma LLP
  • Our Firm
    • Who We Serve
      • Shareholders
      • Whistleblowers
      • Consumers
      • Businesses
      • Government Entities
    • Our Professionals
    • Working with Wexler Boley & Elgersma LLP
    • Locations
    • News
    • Careers
    • Report Your Concern
    • Testimonials
  • Practice Areas
    • Antitrust Litigation
    • Business & Commercial Litigation
    • Securities & Corporate Governance
    • Healthcare Litigation
    • Consumer Protection
    • Whistle Blower False Claims Litigation
    • Government Representation
    • Employment Litigation
  • Cases
    • Antitrust Litigation Cases
    • Business & Commercial Litigation Cases
    • Consumer Protection Cases
    • Employment Litigation Cases
    • Government Representation Cases
    • Healthcare Litigation Cases
    • Mass Tort Litigation Cases
    • Securities & Corporate Governance Cases
    • Whistle Blower False Claims Cases
  • Investigations
    • Similac Toxic Infant Formula Lawsuit
    • Kid’s Castle Biometric Privacy Lawsuit
    • Contaminated Baby Food Lawsuit
    • Fatal Sportmix Pet Food Recall Class Action Lawsuit
    • Claire’s Data Breach Lawsuit
    • Insurance Denial for Mental Health and Substance Abuse Treatment
    • Perpetual Sales Litigation
    • Railroad Price-Fixing Lawsuit
    • Medicare Advantage Fraud Litigation
    • Biometric Fingerprinting Litigation
  • Blog
  • Contact Us
See all news
7.14.2011

FDA Warns Surgeons To Avoid Mesh Devices

Law360, New York (July 13, 2011) — The U.S. Food and Drug Administration on Wednesday warned against using surgical mesh in vaginal surgeries to treat a condition in which pelvic organs sag from their normal position, urging surgeons to consider less risky methods.

The agency issued a similar warning in October 2008, but concluded that serious complications arising from the use of surgical mesh were not rare after being flooded with 1,500 more reports of problems associated with the device from 2008 to 2010.

The surgical mesh is permanently implanted in women to correct pelvic organ prolapse, which occurs when structures that support the bladder, uterus and bowel grow weak or stretched — typically after childbirth — causing the organs to drop.

Implanting the mesh through the vagina can fix the problem, but it can also lead to infections, bleeding, pain during sexual intercourse and urinary problems, the FDA said. Moreover, the agency has received reports that surgical tools used to implant the mesh pierced holes in organs.

“The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh,” said William Maisel, deputy director of the agency’s Center for Devices and Radiological Health. “Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”

The agency has called on an outside panel of experts in obstetrics and gynecology to meet in September to discuss the safety and effectiveness of surgical mesh in treating pelvic organ prolapse and stress urinary incontinence, a condition involving leakage of urine during physical activity.

In 2010, there were at least 100,000 surgeries to treat pelvic organ prolapse with surgical mesh, with about 75,000 of them involving vaginal, rather than abdominal, surgeries. The FDA said abdominal surgeries pose fewer risks, as do procedures involving stitches alone.

According to the agency, there is no evidence that surgeries involving mesh are more beneficial than nonmesh procedures.

The FDA added that complications associated with using surgical mesh have not been linked to a single brand of mesh.

Representatives for Boston Scientific Corp., a surgical mesh manufacturer, did not immediately respond to a request for comment Wednesday.

American Medical Systems Inc., another surgical mesh maker, is facing a lawsuit from a woman who claims she developed severe vaginal deformities and suffered other serious medical problems after undergoing surgery to implant the company’s Apogee mesh system.

The suit, filed in California federal court in March 2008, alleges that Ellen Ambroff required mesh revision surgery and an operation to remove the device after allegedly suffering a litany of medical problems, including rectal bleeding, chronic hip problems, bowel and bladder incontinence, nerve damage, a blood clot in her rectum, chronic fatigue and heart problems.

For the complete FDA alert, please click here. For more information on Wexler Wallace’s surgical mesh cases, please click here.

–Article By Bibeka Shrestha

–Editing by Chris Giganti.

Share

  • Facebook
  • Twitter
  • LinkedIn
Image

311 S. Wacker Drive,
Suite 5450
Chicago, IL 60606
P_312.346.2222
F_312.346.0022

  • Our Firm
  • Practice Areas
  • Cases
  • Investigations
  • Newsroom
  • Blog
  • Contact Us
  • Sitemap
  • Privacy Statement
  • Legal Disclaimer

2022 © Wexler Boley & Elgersma LLP