Lawsuits against manufacturers of transvaginal mesh devices such as Johnson & Johnson and Endo International have been making headlines lately for the ongoing cases and settlements with thousands of women who filed suits after suffering serious and often life-threatening complications due to transvaginal mesh.
Mesh devices are made from polypropylene plastic and were sold as a non-invasive way to treat pelvic organ prolapse (POP) and stress urinary incontinence. However, there have been numerous complaints of the devices breaking apart, erosion and perforation, all of which can lead to intense pain and further complications.
According to the Dallas Observer, thousands of internal company emails and documents have been made public record because of these lawsuits, and in examining the information, there were several instances found where Johnson & Johnson’s pharmaceutical manufacturing arm Ethicon and other manufacturers knew about the problems caused by transvaginal mesh but chose to look the other way. Some examples include:
- “I accept that we need to report the case of dyspareunia because I would agree it would be unethical not to mention since we know about it. However, the way it is presented in the abstract is going to kill us,” Kimberly Hunsicker, research operations manager for Ethicon.
- “There is no reason to expect that the fraying of mesh or the particles generated would create any safety risks,” Marty Weisberg, senior medical director for Ethicon.
- “The [surgeons] maintaining that mesh is sometimes used in cases where it is not necessary by an enthusiastic but less skilled general gynecological surgeon,” was stated in company notes.
These findings make it clear that manufacturers of these devices recognize there are serious risks at stake, but that the necessary precautions are not always taking place.
Mesh complications lead FDA to reconsider classification
Because of this, the U.S. Food and Drug Administration announced recently its proposal to reclassify mesh devices from moderate-risk to high-risk.
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health said in the statement.
Women who have suffered serious and dangerous complications because of transvaginal mesh and are considering filing a lawsuit should contact a lawyer who specializes in these cases. Advocates who have a firm knowledge of mass tort cases can help determine what information is necessary and what steps need to be taken in order to win.
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