Johnson & Johnson (J & J) has been ordered to pay a woman $20 million as a result of defective vaginal-mesh inserts that caused serious damages. This is the first verdict against Johnson & Johnson in the last year; two others are going to trial in upcoming months and there are more than 54,000 more that are pending across the country.
A Philadelphia jury decided that J & J’s TVT-Secur mesh was defectively designed. The plaintiff said that the mesh broke down after being implanted in her body, and she had to have several surgeries in order to fully remove it. She also said that the mesh caused severe, stabbing pain and created further health problems.
Pelvic transvaginal mesh acts as internal support and is often made from animal tissue or synthetic materials. It is most commonly used to treat women with stress urinary incontinence (SUI) or pelvic organ prolapse (POP), and is inserted vaginally. SUI is when the bladder releases urine unintentionally, usually due to physical movement. POP is the result of a weakening of the pelvic muscles and can sometimes allow for the pelvic organs to slip out of place. Pelvic transvaginal mesh can help the pelvic organs stay in place and decrease the likelihood of SUI.
Ethicon is a subsidiary of J & J and sells the transvaginal mesh. In 2013, Ethicon briefly decided to pull the product off the market. This was because there were multiple lawsuits and complaints of consumer injuries. Although J & J had been instructed by state regulators to investigate health concerns, it would appear as though there was a failure to make any significant product changes before Ethicon simply began to sell the mesh once again.
Although representatives from J & J say that the company believes that its mesh has been researched, developed and marketed safely, this is not the first time that they have been found responsible for damages. Since 2014 alone, J & J has paid over $35 million in verdicts against them and has settled numerous other cases. In the near future, the company may consider a large-scale settlement with all complainants in order to avoid facing additional litigation.
The Food and Drug Administration (FDA) has categorized transvaginal mesh as a high-risk device. Although the administration categorized it as a moderate-risk in the past, after multiple reports of serious complications arose, the classification was altered. Reports of complications have been reported since the 1990s. The most common complications that the FDA cites are mesh erosion, infection, pain, bleeding, pain during sex, urinary problems and organ perforation. Additionally, pelvic mesh was never tested for transvaginal safety. This means that it was approved for use in other parts of the body, but not for insertion through the vagina.
Because transvaginal pelvic mesh can be dangerous or fatal, it is very important that it is researched and produced in a safe manner. Although certain devices may inherently carry serious risks, these can often be curtailed when a manufacturer behaves responsibly and advocates for consumer safety.
Another trial against J & J is set to start soon, with the plaintiff claiming that she also suffered serious medical injuries as a result of the pelvic mesh. Experts have predicted that over 100 thousand cases against J & J as well as other manufacturers could result from transvaginal mesh implants.
If you received a transvaginal mesh implant, and have suffered injuries or suspect that you may have complications as a result, you may be entitled to injury compensation. The Philadelphia products liability lawyers at Galfand Berger can help. With offices located in Philadelphia, Reading, Lancaster and Bethlehem, we serve clients throughout Pennsylvania and New Jersey. To schedule a consultation, call us at 800-222-8792 or complete our online contact form.