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Ethicon Mesh Recall and Lawsuit FAQs

Ethicon is a maker of surgical mesh products. Surgical mesh is an artificial, net-like product used by doctors to support weakened or damaged tissue inside the body. During some procedures, doctors insert surgical mesh into a woman’s body through the vagina to better reach the affected area. This is known as a transvaginal mesh procedure.

Q: What is Ethicon Mesh used for?

Transvaginal mesh is commonly used to treat women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Both conditions frequently occur in women following childbirth. Damaged and weakened tissue allows internal organs to shift inside the body, leading to numerous health problems. In treating POP, mesh is implanted in the body to support a weakened vaginal wall. In treating SUI, on the other hand, mesh forms part of a sling system inserted to support internal organs. Besides transvaginal placement, surgical mesh can also be inserted through the abdomen.

Q: What injuries are associated with Ethicon Mesh?

The Food and Drug Administration (FDA) has received thousands of reports of problems related to transvaginal mesh. One of the most commonly reported problems is mesh erosion. Eroding mesh can disintegrate inside the body and migrate, often causing sharp fragments of the synthetic material to scrape and pierce internal organs and tissue. Many women also report pain, infection, urinary problems, bleeding, organ perforation, and a recurrence of POP or SUI. In addition, some women have reported pain during sexual intercourse.

Transvaginal mesh can only be removed by multiple revision surgeries, leading to additional medical procedures and costs. Recent health problems reported by women who received Ethicon transvaginal mesh have led to government action and lawsuits.

Q: Has there been an Ethicon mesh recall?

Not yet. The FDA has issued two public health warnings regarding transvaginal mesh, in October 2008 and July 2011. This has led to increased awareness about the risks associated with transvaginal mesh in the medical community and amongst the public.

However, an Ethicon mesh recall is still possible. Other manufacturers have issued transvaginal mesh recalls and pulled their products from the market. Ethicon has announced that it will stop selling four of its transvaginal mesh products, but has stopped short of recalling products already sold. This market withdrawal applies to the following Ethicon products:

  • Gynecare Prolift Pelvic Floor Repair System
  • Gynecare Prolift+M Pelvic Floor Repair System
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare TVT Secur System

Q: Can Ethicon be sued?

Yes. While an Ethicon mesh recall has not occurred, the company may still be liable for injuries caused by its products. Under product liability law, consumer products must meet the ordinary expectations of consumers. When a product is dangerous or defective, the maker of the product can be found liable. This may be because the product was defectively designed or because defective warnings failed to inform people of the risks of using the product. If successful, injured consumers can recover compensation for medical costs, lost wages from time off work, pain and suffering, and other losses.

Thousands of women have filed lawsuits against Ethicon and its parent company Johnson & Johnson. Over 3,000 claims have been filed in New Jersey alone. The plaintiffs allege, among many other claims, that Ethicon defectively designed its mesh products, failed to warn patients about the risks of using its mesh products, misrepresented its products in marketing materials, and fraudulently concealed information about its products from patients. Some cases that have gone to trial have seen juries award millions of dollars to victims.

Q: I think I may be suffering from Ethicon mesh complications. What should I do?

You should contact your doctor to determine if you are suffering from complications related to an Ethicon mesh implant. If you are, you should contact a lawyer to evaluate your case and determine if you can sue. Lawsuits can hinge on how quickly you file suit, so timely action is important. In addition, you should keep an eye out for a possible Ethicon mesh recall.