Surgical mesh devices – including hernia mesh and transvaginal mesh products – have been associated with a high rate of complications in patients who undergo surgery using these products. Thousands of lawsuits have been filed in the U.S. against companies that manufacture surgical mesh on behalf of patients who suffered complications or who underwent additional surgery in order to repair problems caused by surgical mesh products.
What is Surgical Mesh?
Surgical mesh products are loosely woven sheets of material that are used to provide temporary or permanent prosthetic support for the body’s internal organs. Surgical mesh can be manufactured using organic materials or inorganic substances, including nylon, polypropylene, polyester, and polytetrafluoroethylene (ePTFE).
Surgical mesh products are sold in a wide variety of shapes, sizes, and materials depending on the condition the mesh is intended to treat. Hernia mesh products are used for the surgical repair and support of inguinal or femoral hernias. Transvaginal mesh is used to treat women with stress urinary incontinence or pelvic organ prolapse. Surgical mesh is also used during reconstructive surgery or to treat traumatic wounds.
Hernia Mesh Complications
Although surgical mesh has replaced suture repair as the standard type of hernia surgery in the U.S., treatment with surgical mesh is not without risk of complications. The FDA has warned that patients who undergo hernia repair surgery using mesh may experience potentially serious complications, including:
- Hernia recurrence
- Adhesions (scar-like tissue that sticks tissues together)
- Bowel or intestinal obstructions
- Fistula (abnormal connections between organs or intestines)
- Seroma (fluid build-up around the surgical area)
- Tissue or organ perforation
Some surgical mesh products used for hernia repair have been associated with an increased risk of complications compared to other mesh brands:
- C-Qur Mesh – sold by Atrium Medical Corporation – has been linked to an increased risk of infections, which may be caused by problems with the Omega 3 fatty acid (O3FA) gel coating on the patch.
- Physiomesh – a hernia mesh patch sold by Ethicon – was withdrawn by the company in 2016 after it was associated with an increased risk of complications and hernia revision surgery.
Both Atrium and Ethicon face lawsuits filed on behalf of patients who suffered complications after undergoing hernia repair surgery using surgical mesh products sold by the companies.
Warnings About Transvaginal Mesh
Transvaginal mesh products (also known as pelvic mesh) are surgical mesh devices that are used to treat women with stress urinary incontinence (using a bladder sling or urethral sling) or pelvic organ prolapse. Companies that manufacture transvaginal mesh including American Medical Systems, Boston Scientific, Covidian, C.R. Bard, Ethicon, Gynecare, Johnson & Johnson, and Mentor.
The Food and Drug Administration warned in July 2011 that patients who are treated with transvaginal surgical mesh products face an increased risk of serious complications compared to those who are treated with traditional surgical methods. Transvaginal mesh is used by surgeons to treat patients with stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Concerns about the safety of transvaginal mesh first arose in October 2008, when the FDA issued a warning about the risk complications for patients who receive surgical mesh to treat SUI or POP. After receiving thousands of reports from patients who had experienced problems with transvaginal mesh products, the FDA issued a second warning stating that the complications from mesh products were far more common than had been previously thought.
Complications from Transvaginal Mesh
According to the FDA’s warning about transvaginal surgical mesh, the most commonly reported with the product was erosion of the mesh through the walls of the vagina. In many cases, patients who experienced problems with transvaginal mesh were forced to undergo multiple surgeries in order to fix complications caused by surgical mesh. Other commonly reported complications include:
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
According to a survey conducted in November 2011 at an annual meeting of the American Association of Gynecologic Laparoscopists, many doctors have stopped using transvaginal mesh in the wake of the FDA’s warning due to increased risk of complications compared to traditional surgery. According to the FDA, it may be impossible to fully correct some of the problems that occur after transvaginal mesh surgery, even in cases where patients undergo multiple surgeries to correct these problems.
Hundreds of patients have filed surgical mesh lawsuits against the manufacturers of these products, which include Johnson & Johnson, Boston Scientific, C.R. Bard, Gynecare, and American Medical Systems. A class action lawsuit on behalf of women who were treated with transvaginal mesh has also been filed.
In July 2012, jurors in California awarded $3.6 million to a woman who developed chronic pain and other complications after undergoing transvaginal mesh surgery to treat urinary incontinence. The case was the first surgical mesh lawsuit to go to trial.
If you or a loved one was treated with surgical mesh and have suffered complications from these products, you may be eligible to file a lawsuit. For more information and to find out if you are eligible to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-447-9001 or by completing the free case evaluation form located on this page.