In 2016, the FDA advisory committee met to discuss pelvic mesh devices. The issue on the table? Whether or not to assign a higher safety classification to these controversial implants coated with a petroleum-based plastic called polypropylene. After that, the committee made an unusual ruling. The FDA skipped Class II entirely and reclassified transvaginal mesh (TVM) from Class I to a Class III device. In other words, TVM’s classification as a moderate, low-level device changed to a high-risk device. (For reference, TVM moved from the same safety class as dental floss to the one that includes things like pacemakers.)
And the FDA’s safety classifications for medical devices involves more than just a number. Depending on the class level, the FDA requires manufacturers to strengthen safety test data and provide additional clinical evidence. Because the risks at stake are so high, manufacturers must show each Class III device is essential for patients’ health.
With so many women submitting adverse event reports to the FDA, it makes sense that the agency finally reclassified TVM. The FDA issued a 2011 announcement that extreme pelvic mesh side effects are not rare. Complications range from mesh erosion through the vagina, pain, infection, pain during intercourse, organ perforation, bleeding, vaginal scarring/shrinkage, and emotional damages. Many of these complications have required hospitalization or further surgeries to repair the eroded mesh.
Despite TVM’s known health dangers, it took six years for the FDA to officially reclassify it. And while the reclassification can protect women, many were left with a burning question. Why didn’t the FDA include hernia mesh devices with a polypropylene coating?
What Hernia Patients Should Take Away From the FDA’s Ruling on Polypropylene Mesh Implants
Hernia mesh is very similar to TVM. They’re both formed of a woven material and sewn over a weak area. Both include surgical mesh — which can be made of biological or synthetic materials. The main difference is how they’re used. Hernia mesh is used to bridge the gap in a torn abdominal muscle.
The most common mesh implants for both pelvic repairs and hernia repairs use a polypropylene coating. Polypropylene is a flexible, petroleum based plastic. It is the most frequently used type of surgical mesh, for both hernias and transvaginal procedures. This coating is supposedly strong, safer, and less likely to tear or fragment. Studies compare its tensile strength to steel’s. It is also comparable to high-quality fishing line, which also contains polypropylene.
But one polypropylene plastic disadvantage is that it may actually be too strong. Polypropylene’s strength is far greater than what the body physiologically requires. The body then, recognizes it as a foreign material, which leads to an intense inflammatory response. It can also lead to side effects like scar tissue, and mesh contraction.
One thing that makes polypropylene mesh potentially dangerous is that it shrinks pretty easily. In fact, experts suggest polypropylene mesh may shrink up to 30%-50% after placement. Because of this shrinkage, surgeons often miscalculate the size required. Sometimes, bridging the gap in a torn abdominal wall isn’t enough. The body’s response to the shrinkage can vary. Side effects often include chronic pain, intestinal adhesion injuries and discomfort.
In an effort to reduce these side effects, device manufacturers recently introduced a lighter-weight polypropylene mesh. Clinical tests show this newer, lighter mesh can decrease pain and increase mobility, but may still cause common side effects.
Despite TVM’s serious complication risks, the FDA’s polypropylene warning does not extend to near-identical devices — including hernia mesh.
How TVM Compares to Hernia Mesh
TVM is very similar to hernia mesh, and both devices have a polypropylene coating. Doctors sew TVM into the woman’s vaginal wall to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP is a condition where the bladder, uterus, top of the vagina, rectum, or bowel has descended. Most often this occurs in women who have weakened pelvic muscles from pregnancy or childbirth. Similarly to hernia mesh, TVM is inserted and sewn to create a hammock of sorts, just like hernia mesh is used to form a bridge. Sutured in place, the idea is that as the patient’s tissues grow, it will fill in the pores of the mesh and keep it stable.
Since the FDA’s recent TVM re-classification for safety reasons, fewer doctors recommend it to POP and SUI patients. But hernia mesh, which uses the same polypropylene components (and causes almost identical side effects) is still popular today. The FDA’s polypropylene ruling does not impact hernia patients. But maybe it’s time the FDA considered the risk for hernia patients with polypropylene mesh repairs.
Why Don’t Doctors Warn Hernia Patients About Polypropylene Mesh Risks?
TVM’s new classification requires doctors to emphatically inform patients of the possible risks of the device. But healthcare professionals and surgical mesh manufacturers are not giving hernia mesh patients the same treatment. Even with TVM, medical device makers and their sales staff don’t advertise or declare FDA risks unless forced to. This includes patients who are undergoing surgeries using the devices. Surgeons, for the most part, don’t warn hernia repair patients about all possible risks with mesh implants… even though they’re eerily similar to TVM. Side effect risks for TVM and hernia mesh devices with polypropylene coatings include:
- Palpable mass/bulge
- Difficulty urinating and passing gas
Patients Filing Hernia Mesh Lawsuits May Influence Future FDA Polypropylene Rulings
High-profile lawsuits may explain why the FDA focused on TVM devices made from polypropylene over hernia mesh. TVM manufacturers faced thousands of lawsuits in recent years and paid billions to settle those claims. However, hernia mesh litigation isn’t as popular among injured patients. That may be down to how many hernia patients require revision surgeries after their first repair. Still, more are beginning to come in, especially after Ethicon recalled their popular Physiomesh implant in 2016.
Despite the dangers involved with devices that contain polypropylene, the FDA didn’t reclassify hernia mesh like it did TVM. As a result, thousands are still undergoing hernia mesh surgery without realizing all possible complications.
What Patients With Hernia Mesh Injuries Can Do
If you or a loved one had hernia repair using a polypropylene mesh implant, you may qualify for financial compensation. To whether you may qualify for a cash settlement from the device’s maker, complete your free hernia claim evaluation online today. Once you’ve submitted your information, an experienced lawyer will call to discuss your case. You can then schedule a confidential, in-person meeting to review next steps and possible compensation options privately.
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.