On January 4, 2016, the FDA issued final orders with stricter data requirements for surgical pelvic mesh. Also known as transvaginal mesh, the implant is a net-like device designed to reinforce tissues that have become weak or stretched out due to a variety of reasons. The FDA's actions are the result of an increasing number of mesh-related lawsuits, moving the medical devices up from class II (moderate-risk) to class III (high-risk) with an added requirement for manufacturers to submit premarket approvals (PMAs).
Pelvic Mesh Risks
According to the Minneapolis Star Tribune, "At least 135,000 women and their families have filed personal-injury lawsuits against seven makers of pelvic mesh products." Of these lawsuits, 59,000 are a part of a large consolidation in a West Virginia federal court.
- Transvaginal mesh to treat pelvic organ prolapse (POP)
- Transabdominal mesh to treat pelvic organ prolapse (POP)
- Mesh sling to treat stress urinary incontinence (SUI)
While the surgical procedures certainly have risks of their own, the FDA's orders are only specific to the mesh implants. These devices can develop serious complications, such as:
- Mesh eroding a woman's internal tissues
- Organ Perforation, which is when the wall of a hollow organ is penetrated through mesh erosion
- Vaginal bleeding, discharge, scarring, shrinkage and shortening
- Nerve damage
- Neuro-muscular problems
- Autoimmune problems
- Urinary retention or incontinence
These complications can be incredibly painful and even life-threatening, preventing victims from living a normal life. Many victims were not aware of the risks before having the procedure.
Implications for the Future
With strict regulations on these products, companies will be required to undergo extensive regulatory measures in order to sell the devices. It is likely that many companies will instead cease sales of mesh devices, pulling out of the market.
This could mean fewer options for women seeking pelvic mesh implants in the future. Alternatively, it also could promote better innovation in the industry, creating safer products that don't hold the same kinds of risk. Regardless, it is important to stay up-to-date with product developments, especially if you or a family member has undergone one of these procedures in the past.
Victims of Surgical Mesh Implants
If you or a loved one has been a victim of an injury or death due to a pelvic mesh implant, you may be entitled to compensation for pain and suffering. The Chicago-based attorneys at Lipkin & Apter have over 75 years of combined personal injury law experience, including medical malpractice. We can help you gain the financial support you deserve, so contact us to learn more and schedule a free consultation.