Skip to content
  • (205) 326-3336
  • [email protected]
  • Calls Answered 24 Hours
Facebook-f Twitter Linkedin-in
  • Home
  • About
    • Accolades and Awards
    • Careers
    • In the Community
    • Our History
    • Our People
  • Attorneys
  • Practices
    • Automotive Defects
    • Brain And Spinal Injury
    • Business Litigation Intellectual
    • Class Action and Mass Torts
    • Defective Product Injury
    • Medical Device Injury
    • Nursing Home Abuse And Neglect
    • Personal Injury And Wrongful Death
    • Pharmaceutical Drug Injury
    • Sexual Harassment
    • Trucking And Motor Vehicle Collisions
    • Toxic Chemical Exposure
    • More Practice Areas
  • Cases
    • 3M Military Earplugs Lawsuit
    • Camp Lejeune
    • CPAP
    • Juul Vape Devices Case
    • Paragard IUD Lawsuit
    • Paraquat Exposure
    • PFAS
    • Social Media
    • Talcum Powder
    • Zantac
  • News
    • Blog
    • News
    • Video Resources Page
  • Contact
Menu
  • Home
  • About
    • Accolades and Awards
    • Careers
    • In the Community
    • Our History
    • Our People
  • Attorneys
  • Practices
    • Automotive Defects
    • Brain And Spinal Injury
    • Business Litigation Intellectual
    • Class Action and Mass Torts
    • Defective Product Injury
    • Medical Device Injury
    • Nursing Home Abuse And Neglect
    • Personal Injury And Wrongful Death
    • Pharmaceutical Drug Injury
    • Sexual Harassment
    • Trucking And Motor Vehicle Collisions
    • Toxic Chemical Exposure
    • More Practice Areas
  • Cases
    • 3M Military Earplugs Lawsuit
    • Camp Lejeune
    • CPAP
    • Juul Vape Devices Case
    • Paragard IUD Lawsuit
    • Paraquat Exposure
    • PFAS
    • Social Media
    • Talcum Powder
    • Zantac
  • News
    • Blog
    • News
    • Video Resources Page
  • Contact
Search
Close
  • VIEW MENU
    • About
          • Our Mission and Vision

            Welcome to Heninger Garrison Davis law firm. We are so glad you found us. Whether you are experiencing a business dispute or have suffered a life-altering injury, our attorneys are here to help you navigate the legal system from start to finish.

          • Learn More
          • Accolades and Awards

            Many of our attorneys and the firm itself have received numerous accolades over the years.

          • View Details
    • Practice Areas
      • Brain And Spinal Injury
      • Business Litigation And Intellectual Property
      • Class Action and Mass Torts
      • Defective Product Injury
      • Insurance Disputes
      • Medical Device Injury
      • Nursing Home Abuse And Neglect
      • Personal Injury And Wrongful Death
      • Pharmaceutical Drug Injury
      • Sexual Harassment
      • Toxic Chemical Exposure
      • Trucking And Motor Vehicle Collisions
      • More Practice Areas
    • Attorneys
      • Taylor Bartlett
      • François M. Blaudeau, MD
      • William L. Bross
      • Jacqueline Knapp Burt
      • Timothy C. Davis
      • W. Lee Gresham, III
      • Anna M. Carroll
      • Stephen D. Heninger
      • W. Lewis Garrison, Jr.
      • Mark Ekonen
      • Erik S. Heninger
      • Kathryn Harrington
      • Caroline U. Hollingsworth
      • K. Stephen Jackson
      • Jeffrey P. Leonard
      • Honza J. P. Prchal
      • Christopher B. Hood
      • J. Callen Sparrow
      • Brandy L. Robertson
      • Amanda S. Williamson
      • Jeanie S. Sleadd
    • Support Team
    • Cases
      • Talcum Powder
      • 3M Military Earplugs Lawsuit
      • Camp Lejeune
      • CPAP
      • Juul Vape Devices Case
      • Mercedes Burl Walnut Wood Trim
      • Paragard IUD Lawsuit
      • Paraquat Exposure
      • PFAS
      • Social Media
      • Zantac
    • News
      • photo of exterior sign of birmingham law office
      • Practice Areas
      • News
      • BLOG
      • Video Resources Page
    • Referring Attorneys
    • View All
    • Careers
    • Contact Us
          • Alabama

            2224 1st Avenue North Birmingham, AL 35203

            (205) 549-4523

          • Contact Us
          • Alabama Location
          • Georgia

            2727 Paces Ferry Road SE, Suite 750, Atlanta, GA 30339

            (404) 996-0860

          • Contact Us
          • Georgia Location
          • New York

            5 Penn Plaza, 23rd Floor New York, NY 10001

            (800) 241-9779

          • Contact Us
          • New York Location

Johnson & Johnson Recalls 4 Transvaginal Mesh Products, Asks FDA for Waiver

Transvaginal mesh manufacturer Johnson & Johnson is recalling four of its mesh products following lawsuits filed by hundreds of women who say the mesh is harmful.

Johnson & Johnson announced its recalls in a letter it sent to the U.S. Food and Drug Administration (FDA) and judges presiding over a large mesh lawsuit in West Virginia.

In its letter, Johnson & Johnson said it would no longer sell the Gynecare TVT Secur system, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift + M products made by its subsidiary, Ethicon. The company asked the FDA to give it 120 days before sales were complete.

It also said it would continue to sell another of its mesh product — the Gyencare Gynemesh — after adjusting the device’s labeling about its use.

The four recalled mesh products are used by surgeons to treat stress urinary incontinence and pelvic organ prolapse. Their safety was questioned after reports surfaced of mesh erosion and organ perforation (puncture).

“Ethicon has no present intention to commercialize these products in the future,” according to the letter.

FDA Waiver from Safety Studies?

In exchange for its recall, Johnson & Johnson asked the FDA to waive a requirement it issued for the company to conduct multimillion dollar safety studies scrutinizing its transvaginal mesh brands. The FDA issued the mandate in January 2012 in response to 3,874 reports of injuries caused by products from Johnson & Johnson and 44 other manufacturers.

In its announcement, Johnson & Johnson also asked the FDA to allow it to continue selling one of its other mesh products linked to patient injuries under modified labeling. Johnson & Johnson wants to continue selling its Gynecare Gynemesh PS brand with an added warning label restricting its use in specific surgeries for prolapse and incontinence.

“Ethicon has requested that it be allowed to continue the sale of Gynecare Gynemesh PS using the current instructions for use until the FDA responds to this proposed plan,” Johnson & Johnson’s letter states.

FDA spokesperson Sarah Clark-Lynn said the FDA received Johnson & Johnson’s request and will respond by August 4.

The terms of Johnson & Johnson’s proposal provide the company with an exit from many of the financial consequences of marketing transvaginal mesh.

Before its brands came under fire for their adverse post-surgical effects in 2010, Ethicon generate billions of dollars in revenue for Johnson & Johnson. However the company has paid billions to settle lawsuits, including one settlement of $2.2 billion for charges of drug marketing fraud.

More than than 1,000 mesh recipients filed lawsuits against Johnson & Johnson.

 

anniversary logo for birmingham alabama best personal injury law firm
  • (205) 326-3336
  • [email protected]
  • Mon - Fri: 8 AM - 5 PM
  • HGDLAW Careers

Alabama

  • 2224 1st Avenue North
    Birmingham, AL 35203
  • (205) 326-3336

Georgia

  • 2727 Paces Ferry Road SE
    Suite 750
    Atlanta, GA 30339
  • (800) 241-9779

New York

  • 5 Penn Plaza
    23rd Floor
    New York, NY 10001
  • (800) 241-9779

HGD Law Firm © All rights reserved 2021

Facebook-f Twitter Linkedin-in