FDA responds to consumer concerns on pelvic mesh
Medical devices are supposed to help people in Maryland who struggle with health issues. There are hip and knee replacements, filters that trap blood clots before they reach the heart, pacemakers to stabilize the heart, walkers and canes, and dozens of other inventions. However, despite the promise that these devices are safe to use, thousands of people around the country have filed complaints that allege the devices caused serious harm and in some cases, death.
One of these devices that has come under heavy scrutiny from the US Food and Drug Administration, is something known as a mesh surgical implant. Manufacturers have been named in “tens of thousands of lawsuits” which claim that the mesh caused women unnecessary bleeding, pain and the need for surgery to either remove it or relocate it because it had moved from its original position. The FDA reported that complications were found in around 10 percent of women who have the mesh installed.
Now, the FDA has announced that surgical mesh which is used to treat pelvic organ prolapse has been relabeled as a class III medical device. Essentially, the new label will create more stringent requirements for manufacturers in order to receive FDA approval and the mesh is now considered high risk. One report states that there are 200,000 operations performed to insert the mesh annually and that pelvic issues will occur to around half of all women.
When people have been harmed by a medical device, they will need to show that the defect was connected to either the design of the product, the manufacturing of the device or the label that was placed on it. These requirements can be complicated so it may be of benefit for victims to seek legal help.