In New Zealand, Women Question Safety of Transvaginal Mesh

Carl EvansDefective Medical Devices, Transvaginal Mesh

medical-Supplies

Mesh Patients Form Support Group in New Zealand

Surgical mesh has been the subject of product liability lawsuits in the United States. Tens of thousands of lawsuits have been filed over transvaginal mesh, used to treat pelvic organ prolapse and stress urinary incontinence. Device makers are also being sued over hernia mesh, which is used for hernia repair. Mesh safety concerns are not limited to the US; as women in New Zealand are seeking answers.

Parker Waichman LLP product liability attorneys are well-versed in transvaginal mesh litigation. The firm continues to offer free legal consultations to individuals with questions about filing a lawsuit.

According to the Sunday Star Times of Auckland, 367 New Zealanders are part of a mesh injury support group called Mesh Down Under. Members of the group are men and women who suffered injuries from hernia mesh and transvaginal mesh. The paper interviewed a 68-year-old woman who says mesh injuries have prevented her from having sex for the past eight years.

The woman, a grandmother from Whangaparaoa, used to be a business owner. “We had to sell our business, because it involved me driving and I just couldn’t do it, so we retired early. We had plans to travel, but I did one flight to Singapore and it was awful – it was so embarrassing and I had to change almost constantly,” she said to Sunday Star Times. Mesh injuries can include severe pain and bleeding, constant bladder infections and nausea. Some women have undergone multiple surgeries to remove the mesh.

Sunday Star Times reports that mesh injuries are probably more common than expected. The paper reports that four patients in New Zealand have died of complications associated with surgical mesh. Professional committees made recommendations in 2016, but the Times says their advice has largely been ignored.

Mesh patients in New Zealand are now calling for government agencies to launch an investigation into surgical mesh.
Advocates and mesh patients are raising questions about the use of surgical mesh in New Zealand, given the safety concerns. For example, hernia mesh for stomach defects is one of the most common surgeries in the country.

Dr. Gerald Young, a doctor in Auckland with a special interest in the surgery, says he would prefer non-mesh methods. “Why take the risk of ongoing groin pain if you don’t have to?” he said, according to Sunday Star Times.
According to Medsafe, pelvic mesh complications included rectal damage, infection, holes in the bladder and urethra, vaginal wounds, fecal incontinence, leg, bowel, and pelvic pain, and ongoing pain, nausea, bleeding and discharge. In 2014, one woman reported “Severe pain and bleeding following intimacy.”

Many reports cite “Erosion causing pain, discharge, infection,”

In the U.S., pelvic mesh was approved for sale without clinical testing for safety and efficacy. According to the Sunday Star Times, the mesh implants were similarly approved in New Zealand. “Further investigations revealed Medsafe has allowed more than 56,000 devices to be supplied on the New Zealand market since 2005, without requiring any proof of clinical safety or efficacy,” the paper states.

Pelvic Mesh Lawsuits and Injuries

Transvaginal mesh, also known as pelvic mesh, is approved to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Pelvic organ prolapse is when a pelvic organ, such as the bladder, falls from its normal place and bulges, or prolapses, in the vagina. POP is more common among women after childbirth, a hysterectomy or menopause. SUI is the involuntary release of urine during everyday activities such as sneezing or laughing.

Transvaginal mesh was designed to treat POP and SUI by providing additional support to sagging pelvic organs and muscles. However, thousands of women allege that the mesh inserts only caused complications. Plaintiffs allege that the mesh was designed defectively, and that mesh makers knew about the risks but failed to warn patients or the medical community.

In 2008, the FDA said that mesh complications were rare, but serious. The agency said the most common injuries reported with transvaginal mesh include:

• Mesh erosion
• Infection
• Pain
• Urinary problems
• Recurrence of prolapse
• Incontinence

Perforation of the bowels, bladder and blood vessels were also reported, FDA said.

Mesh erosion is a complication where the mesh moves through the tissues of the vagina and leads to other complications such as organ damage. In some women, mesh erosion has resulted in multiple surgeries to remove the mesh.

In 2011, the agency revised its previous communication to state that transvaginal mesh complications are “not rare”. The FDA also said transvaginal mesh does not appear to have clear benefits for POP patients compared to non-mesh methods, and may pose additional risks.

The FDA approved transvaginal mesh and hernia mesh through 510(k), which approves products without clinical testing for safety or efficacy so long as manufacturers prove that the products are “substantially equivalent” to a previously approved product, even if that product had safety issues of its own.

Pelvic mesh has been reclassified from “moderate-risk” to “high-risk”. Moderate-risk devices must be approved through the FDA’s stricter premarket-approval, which requires manufacturers to submit data showing that their products are safe and effective. In the past, however, high-risk devices have been approved through 510(k) due to a regulatory loophole.

Hernia Mesh Lawsuits and Injuries

Lawsuits are also being filed over hernia mesh, used in hernia repair. Specifically, Ethicon and parent company Johnson & Johnson are being sued over the Physiomesh Flexible Composite Mesh. The device was withdrawn from the market in May 2016 due to a high rate of recurrence and reoperation.

Atrium Medical is also being sued over its C-Qur (pronounced “secure”) hernia mesh. C-Qur hernia mesh lawsuits have been consolidated into a federal multidistrict litigation (MDL). Alleged injuries include infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function. Some plaintiffs allege that mesh injuries are caused by the mesh’s fish oil coating.

Filing a Transvaginal Mesh Lawsuit

If you or someone you know suffered injuries related to the use of transvaginal mesh implants, you may have valuable legal rights. Our transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).