Vaginal Mesh Lawsuits
Overview of Transvaginal Mesh Lawsuits
In 2005, an alternate to the hernia repair graft material — the vaginal mesh — was created to be implanted into the vaginal wall and distributed for use. In 2007, the FDA began receiving reports about the dangers inflicted by this same product. In that same year, Johnson & Johnson released an altered version of their Prolift vaginal mesh named Prolift+M. The FDA required a pre-market notice (PMN) or 510k be submitted to assure that the changes made continued to be cleared for safety and efficiency purposes. It wasn’t until 2008 that both of these products were approved, three years after the Prolift had already been implanted into a number of women without first knowing how it would affect the vagina specifically. In 2011 the FDA released a notice concerning the dangers involved with implementing various vaginal mesh devices into women suffering from pelvic organ prolapse or stress urinary incontinence.
Between 2005 and 2010, over 2,500 reports were submitted to the FDA alone for the harm caused to unknowing victims.
Side Effects and Injuries
Because the surgeon has limited visibility during the operation, a perforation may occur, worsening the prolapse condition and causing new problems for the patient. A doctor inexperienced in performing or practicing the specific prolapse repair surgery creates a higher risk that a patient may experience more blood loss, increased duration of operation, likelihood of further damage to organs or failure to install the mesh correctly. Post operation, the patient may experience side effects such as bleeding, infection, urinary complications, vaginal tightening, organ perforation, and pain during sex.
The highest reported complication with the surgery is mesh erosion, where the mesh deteriorates the surrounding tissue and remains exposed outside of the wall. The material is then felt by both the patient and her partner, experiencing increased pain and discomfort, often described as “the grating of a window screen” outside of the vaginal wall. Treatment for mesh erosion may require multiple surgeries to either remove or repair the damaged area.
Companies Under Scrutiny
While the FDA states that no single company is at fault for a certain brand of mesh, many are under watch as reports are submitted.
These companies include Ethicon subsidiary of Johnson & Johnson, C.R. Bard, Boston Scientific, and American Medical Systems.
Contact the transvaginal mesh lawyer, Mike Gallagher, and his staff at The Gallagher Law Firm to discuss any questions and concerns you may have regarding cases against these companies. Call (713) 238-7705 or contact us online.