In June of 2012, the Ethicon, Inc. division of Johnson & Johnson notified the US Food and Drug Administration that it would no longer be offering some of its Gynecare Women’s Health Mesh products. Although this Ethicon mesh recall was voluntary and not mandated by the FDA, Johnson & Johnson will also case to commercialize these products. They will also be notifying physicians and patients in order to allow them the opportunity to select other treatment options. The four products impacted by this mesh recall decision by Ethicon are the following:
- Ethicon Gynecare Prolift Pelvic Floor Repair System
- Ethicon Gynecare TVT Secur System
- Gynecare Prosima Pelvic Floor Repair System
- Gynecare Prolift+M Pelvic Floor Repair System
Ethicon Mesh FDA Warning
These decisions by Ethicon to recall the advertisements and offering of these mesh products comes following several warnings from the FDA regarding the increased risk of complications associated with the transvaginal use of surgical mesh. As early as 2008, the FDA warned about vaginal mesh following a large number of adverse event reports in the time period between 2008-2007. However, from2008-2010, there were an even larger number of incidents reported. When the US Food and Drug Administration compiled literature regarding Ethicon and other brands of mesh using data from 1996-2011, they were able to conclude that complications from vaginal mesh are NOT RARE and mesh products were deemed an area of ongoing concern.
Ethicon Mesh Recall Lawsuits
The victims of Ethicon Mesh injuries often choose to pursue litigation against the manufacturer of their particular device. At present there is both state and federal level litigation pending against Johnson & Johnson’s Ethicon, Inc. Additionally, mesh recall lawsuits are pending against several other manufacturers as well, including C. R. Bard, Boston Scientific, and American Medical Systems. Many of these mesh lawsuits were filed after the FDA declared that transvaginal mesh did not appear to provide any benefits for patients that would justify the increase in risk and complications.
File an Ethicon Mesh Recall Lawsuit: Attorney Consultation
Have you experienced mesh erosion or other serious injury following treatment with an Ethicon mesh implant? If so, contact the Willis Law Firm today for a free and confidential recall lawsuit consultation. We know that these are potentially embarrassing women’s health issues, so we have female consultants available for your comfort. Currently, we are assessing Ethicon lawsuit claims in all fifty states, and all mesh clients are represented on a fee contingent basis. If we don’t recover for you, you don’t have to pay any legal or attorney’s fees.
