As women get older, have children, or if they need a hysterectomy, they face an increasing risk that they will develop pelvic organ prolapse or stress urinary incontinence. One common way that medical professionals have chosen to address these issues in women is by using transvaginal mesh. Transvaginal mesh describes a method that is used to insert a specific type of medical mesh into the body to support pelvic organs. The mesh is inserted through the vagina. Although it is less invasive than traditional surgery, transvaginal mesh is hurting and killing women around the country. Sadly, this isn’t the first instance in how the FDA has failed to protect women.
Transvaginal Mesh Lawsuits
Close to 70,000 transvaginal mesh lawsuits have been filed at both the federal and state level combined. These lawsuits allege that they were severely injured by the insertion of transvaginal mesh. Although there are several types of mesh available, they all pose dangerous health risks. Scar tissue can grow around the mesh making it nearly impossible to remove and causing severe pain. The mesh can break off and puncture organs.
No Human Trials
Much like other let downs by the FDA concerning women’s health, transvaginal mesh was never implanted inside of a human vagina before it was cleared. Sadly, it wasn’t until complications were reported that the FDA decided that they should more closely investigate transvaginal mesh.
FDA’s Poor History of Protecting Women
Despite the FDA’s initiation of the Office of Women’s Health, their history of protecting women against dangerous devices like transvaginal mesh has been anything but stellar. Although there are numerous drugs and procedures manufactured specifically for women, the FDA does not necessarily invoke the same requirement for testing. In fact, women are often excluded in clinical trials despite the FDA knowing that women are twice as likely as men to develop an adverse drug reaction.
Male data simply cannot be seamlessly transported over to represent women. There are many factors, such as hormones, that must be considered. These factors have resulted in skewered clinical studies and the release of drugs and medical devices that are inherently unsafe for women. Transvaginal mesh, and its lack of testing with women, is just one example. Examples of this date all the way back to the 1970s when clinical testing of hormone replacement therapy showed a clear indication of presenting more dangers than benefits. Yet, the FDA approved it for use in women.
The Research for All Act would mandate that women are fairly represented in clinical studies. This is particularly important since women account for 80% of individuals who require the use of a prescription or medical device.
Were You Injured Because of Transvaginal Mesh?
If you were injured because of transvaginal mesh, you may benefit from filing a transvaginal mesh lawsuit You should not have to continue to suffer both physically and financially because you chose a medical device that you believed was safe. To have your case evaluated, call Goldwater Law Firm right away.