Ethicon, a division of Johnson & Johnson, manufacturers vaginal mesh devices intended to repair pelvic organ prolapse and stress urinary incontinence. Though some users report positive results, many found their health issues worsened once their mesh device was in place – some even experienced painful side effects and required follow-up procedures to repair the damage caused by their mesh device.
Common medical issues caused by Ethicon’s mesh products include:
- Pain
- Mesh erosion or hardening
- Infection
- Urinary problems
- Injury to organs
- Difficulty with sexual intercourse
Johnson & Johnson and Ethicon are not the only manufacturers accused of putting patients at risk with mesh devices, but Ethicon is a primary manufacturer and was one of the first companies to sell mesh products. There are many mesh products in use produced by the company. Mesh products in question include Ethicon’s:
- Gynecare Prolift Pelvic Mesh
- Gynecare Prosima Pelvice Mesh
- Gynecare Gynemesh
- Prolene Mesh
- Gynecare TVT Sling
A 2010 study published in the Journal of the American College of Obstetricians and Gynecologists showed the rate of mesh erosion for Ethicon’s Gynecare Prolift to be more than 15%, causing researchers to question the value of the device for vaginal prolapse repair. This is just one of many mesh devices that has medical experts questioning the safety of Ethicon’s products.
FDA Acknowledges Serious Concerns with Mesh Safety
Problems with mesh devices have become so severe the FDA is now involved. The agency received thousands of reports from women suffering various medical complications after their Ethicon mesh devices were put in place. Making matters worse, there is limited evidence mesh products offer enough benefit for women experience pelvic organ prolapse or incontinence to make the potential risks worth it.
The FDA originally issued a Public Health Notification and Additional Patient Information in 2008 related to mesh complications, listing more than 1000 adverse events reported in conjunction with mesh devices over a three year period.
An updated Safety Notification was then issued in July 2011, informing doctors and patients that serious complications with mesh products for transvaginal repair are not rare. From the period between the prior safety warning and December 2010, the FDA received an additional 2874 reports of mesh complications related to pelvic organ prolapse repair. The latest warning was a change from the 2008 report and also noted there is no clear evidence that mesh is more effective than non-mesh repair options for patients with pelvic organ prolapse.
In its review of approximately 15 years’ worth of data published on transvaginal mesh devices, the FDA found mesh devices present risks in pelvic organ prolapse repair not present when non-mesh devices are used to treat the problem. It also found there is no evidence mesh repair to support the top or back wall of the vagina provides any additional benefits compared to non-mesh treatment methods.
The FDA reported erosion through the vagina as the “… most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh.” Other common complications noted in the report included pain, infection, bleeding, painful intercourse, organ perforation, and urinary problems.
The FDA continues to investigate the safety of transvaginal mesh products and intends to communicate any new findings in the future.
Ethicon and Johnson & Johnson Face Fraud Charges
As a result of complications related to mesh devices, Johnson & Johnson and Ethicon now both face thousands of lawsuits from injured users. Additionally, Attorneys General in California and Washington recently filed consumer fraud lawsuits against Johnson & Johnson, alleging the company failed to provide adequate warning about the risks related to vaginal mesh products. The lawsuits, both filed May 24, 2016, also allege the company violated consumer protection laws by using deceptive advertising.
In his news conference detailing the lawsuit, Washington Attorney General Bob Ferguson told media, including the Wall Street Journal, “For many victims, their health and their quality of life were forever changed as a result of this deception. Sitting upright, lying on their side, walking all became incredibly painful. … These women were robbed of their ability to live and work in the way they once did.”
Sources:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
http://www.wsj.com/articles/washington-california-sue-johnson-johnson-over-vaginal-mesh-implants-1464135609
