“Simple” Surgery with Transvaginal Mesh Causes Severe Complications, Personal Injury Lawsuit
Linda Gross, 46 years old from South Dakota, was suffering bloating and constipation related to pelvic organ prolapse, a condition in which organs in the pelvis begin shifting due to weakening of the muscles in the pelvic wall. Her doctor recommended a transvaginal mesh implant – specifically, the Gynecare Prolift, which at the time was a new, lauded device.
That was in 2006. Ever since her transvaginal mesh surgery, Gross has suffered a host of painful side effects.
“She can no longer sit comfortably for more than a few minutes without having to either stand up or lay down to try to reduce the level of pain,” Gross’s attorneys said in court papers filed in Atlantic City. “She requires various daily medications to treat her severe chronic pain.”
She has also endured 18 subsequent operations. Transvaginal mesh is notoriously difficult to remove, as some of the side effects include organ perforation, and organ growth around the mesh implant. One plaintiff in a transvaginal mesh lawsuit claims that the devices are incompatible with the human body.
“It’s horrible. There are unknown amounts of the mesh still in me. I have extreme pain. It feels like the inside of my vaginal wall is on fire,” Gross told ABCNews.com. “I wouldn’t wish this on anyone.”
Gross, along with thousands of other women, is suing Johnson & Johnson for personal injury, failure to warn, defective product design, and negligence.
Johnson & Johnson denies wrongdoing, but in August 2012, the company removed four of its transvaginal mesh devices from the market, including the Prolift model that Gross’s doctor used to treat her prolapse.
The Transvaginal Mesh Injury Lawsuit Against Johnson & Johnson
There are around 1,800 individual lawsuits against Johnson & Johnson and their subsidiary, Ethicon, which manufactures the Gynecare Prolift device. These lawsuits have been consolidated into MDL No. 2327, in the US District Court of West Virginia.
Gross’s lawsuit will be the first in the MDL to go to trial. Jury selection began on January 7th, with a final jury panel decision made on January 9th. Opening statements will begin January 10th.
Presiding Judge Carol Higbee has struggled in the past weeks with what specifically lawyers can tell jurors about the transvaginal mesh devices. According to reports, J&J began selling the Prolift devices without filing for the FDA’s notorious 510(k) process – a process which fast-tracks devices that are designed similarly to previously-approved devices – in 2005. In 2007, the FDA ordered J&J/Ethicon to file for 510(k) clearance, which they did, and the FDA approved the device in 2008, without levying any sanctions against the manufacturer.
Lawyers for both sides debated on January 4th about the specific wording for this piece of evidence. Judge Higbee determined that words such as “illegal,” “fraud,” and “similarly inflammatory language” cannot be used when discussing this topic.
In the same hearing, Judge Higbee determined that a doctor will be allowed to testify regarding Gross’s physical and mental anguish. J&J insisted that the doctor would claim Gross was mentally ill, and that she wants to “hold on to her pain,” but Judge Higbee did not foresee a doctor making such statements.
While transvaginal mesh personal injury lawsuits go to trial in this, and five other MDLs, the FDA still has not decided whether or not they will pull the defective, dangerous devices from the market.
The Strom Law Firm Can Help with Transvaginal Mesh Injury Cases
If you or a loved one have had surgery involving transvaginal mesh, and have since suffered painful side effects including bleeding, infection, organ perforation, and constant pain in the lower extremities, you may be entitled to compensation. The attorneys at the Strom Law Firm understand the suffering caused by defective devices like transvaginal mesh, and can help with your case. We offer free, confidential consultations to discuss your concerns, so do not hesitate to contact us. 803.252.4800.