In May 2016, Ethicon (subsidiary of Johnson & Johnson) recalled Physiomesh® — a surgical mesh for repairing ventral hernias. Earlier in 2011, the Food and Drug Administration issued a Public Health Notification about Ethicon’s transvaginal mesh (TVM) devices. Patients reported early failure rates and extreme side effects with both now-recalled products. The striking similarities among TVM and hernia mesh complications make experts wonder whether Ethicon’s surgical mesh products are really safe. Meanwhile, lawsuits against Ethicon are now underway for failing to warn consumers about potential TVM and hernia mesh complications and marketing defective products.
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TVM & Hernia Mesh: How They’re Similar
Scientists created surgical mesh in the 1950s to repair abdominal hernias. In fact, that’s exactly what Physiomesh was used for before the global recall. Hernia mesh is woven material typically used as a patch (or “bridge”) to cover holes in the abdominal wall. It’s then sewn into place to prevent intestines and other organs or tissues from coming through the abdominal wall.
Surgical meshes can be made from biological materials, such as pig’s skin. Hernia and transvaginal mesh may also include synthetic materials, like gels, plastics, polyester fibers and stainless steel. Surgeons cut hernia mesh into an appropriate size, cover the hole, and stitch it into place during ventral hernia repair. Since hernia mesh surgery’s often successful, surgeons found similar uses for surgical mesh in other areas with weakened muscle tissue.
Vaginal mesh and hernia mesh have similar uses. Originally, surgeons inserted vaginal mesh through the abdomen. Now, surgeons insert transvaginal mesh through the vagina to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP occurs when the bladder, uterus, top of the vagina, rectum, or bowel descends from its normal position, causing pain. It’s more common in women with weakened pelvic muscles from pregnancy or childbirth. Much like hernia mesh, surgeons insert TVM and sew it into place to create a hammock-like support structure. As the patient’s tissues grow, the mesh pores fill in to keep the device correctly positioned and stable.
Healthcare providers now avoid vaginal mesh due to potentially severe side effects. Adverse event reports that triggered Physiomesh’s recent recall bear striking similarities to those reported with failed TVM implants. In fact, these similarities raise questions about the safety of Ethicon’s other surgical mesh devices.
Hernia Mesh Complications Strikingly Similar to TVM
Many women with faulty TVM subsequently sued vaginal mesh manufacturers, including Ethicon. More severe vaginal mesh complications may include:
- Pain
- Infection
- Bleeding
- Organ perforation
- Erosion
- Internal bleeding
The FDA’s 2011 report on TVM dangers stated, “The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.” Patients with faulty TVM often need painful and often ineffective correction surgery.
Hernia mesh complications closely resemble serious TVM side effects. Since Physiomesh is more likely to cause hernia recurrence than other types of hernia mesh, symptoms can include:
- Pain
- Palpable mass/bulge
- Vomiting
- Difficulty urinating and passing gas
- Fever
- Sweating
- Redness
While both surgical meshes can cause these symptoms, Physiomesh adverse event reports prove how eerily similar they are.
TVM & Hernia Mesh Complications Drive Product Liability Lawsuits
In September 2016, Joanne Quinn filed a Physiomesh lawsuit against Ethicon. Quinn needed significant surgery for painful hernia mesh complications. According to her lawsuit, “Due to the severe adhesions to the bowels and abdominal wall caused by the defective Physiomesh, Dr. Nassif [Quinn’s surgeon] ended up spending over two hours during the surgery to remove the defective Physiomesh but was unable to remove all of the offending material.”
These adhesion and mesh erosion allegations echo those from injured TVM plaintiffs. California native Coleen Perry was implanted with an Abbrevo mesh sling for her POP (Ethicon also makes Abrevvo mesh devices). After surgery left Perry in extreme pain, her physicians tried to remove the device. Because the Abbrevo sling had already grown so deeply into her pelvic tissues, surgeons could only partially remove it. In 2015, a California jury awarded Perry $5.7 million in punitive and compensatory damages for her pain and suffering.
Recent Ethicon Mesh Device Recalls
In June 2012, Ethicon recalled four Gynecare mesh inserts — including the popular Prolift implant. (The Abrevvo and other incontinence mesh-sling lines are still widely available.) Ethicon’s recall came six months after the FDA ordered device manufacturers to study organ damage and other surgical mesh-related complications. In 2016, Ethicon issued a Physiomesh voluntary recall after patients reported injuries with surprising similarities to those from TVM. Perhaps Ethicon realized the potential liability issues from similar failure rates and injuries and took preemptive action.
What You Can Do
Lawsuits are currently pending against TVM and hernia mesh manufacturers. Because Ethicon failed to properly conduct safety tests and warn consumers about potential dangers, mesh patients suffered irreparable damage. If you or a loved one had hernia or TVM surgery, regardless of the manufacturer, you may have a case. Get you free case review today to see if you may qualify for financial compensation.
Related: Hernia Operation Risks: What You Need to Know Before Surgery
Mandy Voisin
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.