Johnson & Johnson’s subsidiary (Ethicon Inc.) became a major manufacturer of vaginal mesh devices in the early 2000s, developing multiple product lines marketed to treat pelvic organ prolapse and stress urinary incontinence developing in women.
These polypropylene synthetic material mesh implants were promoted as minimally invasive solutions offering permanent support for weakened pelvic organs.
Evidence of severe complications prompted regulatory intervention, resulting in FDA warnings beginning in 2008 and culminating in the company’s voluntary withdrawal of several mesh products from the market in June 2012.
Gynecare Product Line Overview
Ethicon developed and marketed several transvaginal surgical mesh products under the Gynecare brand, with thousands of women receiving these surgically implanted devices across the United States:
- Gynecare Prolift – Approved in 2005 for pelvic organ prolapse repair, this was one of Ethicon’s flagship mesh systems designed to provide comprehensive pelvic floor support
- Gynecare Prolift+M – An enhanced version approved in 2008 featuring partially absorbable mesh components intended to reduce complications while maintaining structural support
- TVT-O (TVT Obturator) – Introduced in 2003, this tension-free vaginal tape system treated stress urinary incontinence through a transobturator approach
- TVT Secur – Launched in 2006 as a single-incision mini-sling system marketed as a less invasive alternative to traditional slings
- Prosima Pelvic Floor Repair System – Released in 2009 for anterior and posterior vaginal wall prolapse repair
While Johnson & Johnson has not provided full disclosure of exact patient implantation numbers, FDA data indicates that in 2010 alone, approximately 75,000 women underwent transvaginal mesh procedures for pelvic organ prolapse and over 200,000 received mesh implants for stress urinary incontinence in the United States.
Court documents suggest that by 2016, Johnson & Johnson faced over 42,000 mesh-related lawsuits (along with competitor Boston Scientific), indicating the widespread use of these devices and how manufacturers put profits ahead of patient safety.
TruLaw partners with vaginal mesh litigation leaders to provide clients with the legal resources and support necessary for pursuing compensation for injuries caused by these defective medical devices.
2012 Market Withdrawal and FDA Regulatory History
The regulatory timeline for Ethicon’s mesh products reflects increasing awareness of the device’s risks that ultimately led to market withdrawal:
In October 2008, the FDA issued its first Public Health Notification about transvaginal mesh, alerting healthcare providers and patients to reports of complications including mesh erosion, infection, pain, and organ perforation.
The agency received 1,000 adverse event reports related to transvaginal mesh between 2005 and 2008.
The FDA escalated its warnings in July 2011 with an updated Safety Communication stating that serious complications associated with transvaginal mesh for pelvic organ prolapse were “not rare”.
Between 2008 and 2010, the FDA received an additional 2,874 adverse event reports, with 1,503 specifically related to POP repairs.
Facing mounting litigation and regulatory scrutiny, Ethicon announced in June 2012 that it would voluntarily discontinue four transvaginal mesh products: Gynecare Prolift, Prolift+M, TVT Secur, and Prosima.
The company cited commercial reasons for the withdrawal while maintaining the products were safe, though internal documents later revealed concerns about inadequate testing and known complications.
The FDA continued strengthening regulations, reclassifying transvaginal mesh for POP repair as Class III (high-risk) devices in 2016, requiring more rigorous premarket approval.
This regulatory shift acknowledged that these devices posed greater risks than initially understood when they were fast-tracked to market through the less stringent 510(k) clearance process.
In April 2019, the FDA took its strongest action by ordering all manufacturers to immediately stop selling and distributing transvaginal mesh products for POP repair, effectively banning these devices from the U.S. market.
The agency determined that manufacturers had not demonstrated reasonable assurance of safety and effectiveness for these devices.
If you or a loved one experienced severe complications from an Ethicon vaginal mesh implant, you may be eligible to seek compensation.
Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing an Ethicon vaginal mesh lawsuit today.