Hundreds of Australian women have launched a class action case against American drug maker Johnson & Johnson over its vaginal mesh implants, which they claim can cause debilitating and irreparable pain to users.
More than 700 patients from all over Australia filed a lawsuit against Johnson & Johnson for allegedly failing to warn the public about the risks associated with its mesh implants. They also claimed that the devices were not fit to address the health issue they were made for, and that they were not properly tested before being made available.
As many as 8,000 women in Australia and thousands more in other countries depend on vaginal mesh implants to help deal with pelvic floors and urinary incontinence. Women often develop these conditions after they give birth.
The plaintiffs, however, argued that Johnson & Johnson's devices instead caused them to suffer excruciating pain after they began eroding into surrounding tissue and organs. They also became more susceptible to infections and complications because of the mesh's erosion. To make matters worse, the medical implants cannot be removed from the patients' bodies.
Some women also claimed that they still suffered from chronic pain even after they had further surgery done to address the issue.
The class action lawsuit is described as the largest such case ever to be filed in Australia. Shine Lawyers, the legal group representing the plaintiffs, said the commencement of the case is an important step toward justice, accountability and recompense.
Attorney Jan Saddler from Shine Lawyers explained that the biggest problem with the vaginal mesh implants is the severe damage they can cause to surrounding tissue and organs once they erode. The resulting chronic inflammatory response causes the patients to suffer debilitating pain.
Saddler added that the chronic pain has also led to relationship problems for affected women since they could no longer have any sort of sexual relationship. Those who could still have sex often experience severe pain because of the damage caused by the implants. Saddler pointed out that the patients' condition has severely affected their way of life.
Johnson & Johnson's Vaginal Mesh Implants
According to Johnson & Johnson, it has sold more than 100,000 mesh products in Australia alone. Of the nine different medical devices mentioned in the class action lawsuit, the drug company has already pulled five from the market. So far, Australian regulators have not recalled any of Johnson & Johnson's mesh products.
In 2016, the U.S. Food and Drug Administration reclassified all pelvic mesh implants from being "moderate" to being "high risk" for patients. This made the products subject to stricter regulatory guidelines. The agency, however, has not issued any product recalls for the devices.
Johnson & Johnson argued that the use of its mesh implants has helped millions of women around the world deal with pelvic organ prolapse and urinary incontinence. The drug maker added that many of the patients who have had surgery experienced positive results.