Rectifying the dangers of pelvic mesh in Indiana
In response to thousands of reported injuries, the FDA announced on Jan. 4 that makers of pelvic mesh must submit new applications proving that their products are safe and effective. Common complaints include pain, bleeding and infection, and in some cases, it took one or more surgeries to remove or reposition the mesh after complications arose. It is important to note that the new rules only apply to mesh used to help with pelvic collapse in women.
Mesh used for other conditions such as hernias or incontinence will not fall under the new guidelines. Mesh was created in the 1990s and touted as an alternative to traditional surgery, but the FDA concluded in 2012 that its benefits have not been verified. Companies such as Johnson & Johnson, Boston Scientific and Endo International have faced thousands of lawsuits related to their pelvic mesh products. In 2014, Endo agreed to pay $830 million to settle in excess of 20,000 such cases.
Under the new guidelines established by the FDA, companies that currently market pelvic mesh products will have 30 months to submit new applications. Companies that want to market products in the future will need to get permission before doing so. Furthermore, pelvic mesh procedures will now be considered to be high-risk as opposed to medium-risk as they are currently classified.
Those who have been hurt by defective products may wish to contact a personal injury attorney. Doing so may make it easier to pursue compensation for medical bills and lost wages related to recovering from the injury. Lost future earnings may also be part of any award granted to an injured victim. In some cases, an award may be granted outside of court through informal settlement negotiations.