Kentucky Couple Files Vaginal Mesh Lawsuit in Federal Court
Fraudulent concealment and negligent misrepresentation are some of the allegations levied against Ethicon, Gynecare, Inc. and Johnson & Johnson in a vaginal mesh lawsuit filed by a Kentucky couple.
On July 6, 2012, the plaintiffs filed a legal complaint against the medical device manufacturers in the U.S. District Court for the Northern District of California San Francisco Division. The Kentucky wife joined thousands of women who stated that they suffered serious bodily injuries as a result of receiving a defective vaginal mesh implant.
Transvaginal mesh complications
Transvaginal mesh products were developed to treat women suffering from medical conditions such as pelvic organ prolapse and stress urinary incontinence. The FDA granted approval for surgical mesh products through its controversial 510(k) process. Under section 510(k) of the Food, Drug and Cosmetic Act, the FDA will approve a medical device as long as it is substantially similar to other devices already placed in the market. The approval process doesn’t require the manufacturer to conduct safety clinical studies prior to distributing the devices.
On October 20, 2008, the FDA issued a Public Health Notification after more than 1,000 complaints were submitted within a three-year period to the agency regarding the vaginal mesh devices. According to the FDA’s Manufacturer and User Facility Device Experience database, the defendants’ vaginal mesh products were listed in some of the complaints. Three years later, the FDA stated that surgical mesh products were a subject of serious concern. Based on an analysis of the complaints filed with the FDA and a review of the scientific studies conducted on the devices, the agency concluded that patients suffering from medical complications wasn’t a rare occurrence.
Physicians and researchers attributed the high failure rate of the surgical mesh devices to a number of factors. The immune systems of some patients had an adverse reaction to the polypropylene material used in the devices. And the design of the products caused major nerve damage in some women. Other medical complaints linked to the device include mesh erosion, infections, inflammation, organ perforation, urinary incontinence, and pain during sexual intercourse.
Causes of action against vaginal mesh manufacturers
The recent vaginal mesh lawsuit claims that Ethicon falsely promoted its products as a safe and effective treatment for pelvic organ prolapse and stress urinary incontinence. According to court documents, the faulty design of the surgical mesh products caused severe bodily injuries to patients rather than sufficiently treat their pre-existing medical conditions. The plaintiffs contend that the manufacturers also knew about the substantial danger the products posed to patients based on the results of scientific studies and FDA complaints, yet an adequate warning was not issued to consumers or healthcare providers.
Patients, consumer advocates and medical professionals have been requesting a transvaginal mesh recall for several years. After numerous lawsuits were filed against Ethicon and the surgical mesh complaints increased, the drug manufacturer decided to remove the products from the market in June 2012. Even though Ethicon and Johnson & Johnson stopped distributing vaginal mesh products, they never issued a recall.
Plaintiff suffers injuries from vaginal mesh implant
The plaintiff had a medical condition known as cystocele – where the bladder isn’t able to stay in its proper position due to weak vaginal walls. This condition often results in urinary incontinence, pain and discomfort. On February 25, 2009, a transvaginal mesh device was implanted to strengthen her vaginal walls and alleviate the condition. As a result of receiving the surgical mesh, the plaintiff claims to have suffered from debilitating complications including continual bladder infections, tissue damage, and chronic pain. She underwent multiple surgeries and received other forms of treatment for her injuries.
The transvaginal mesh side effects lawyer stated that his client not only sustained physical pain and suffering, but also endured severe mental distress. The lawsuit requests compensatory and punitive damages that were incurred as a direct result of the plaintiff’s injuries. The woman’s husband is seeking compensation for loss of consortium and loss of marital support, as well as other damages.