Doctors sometimes use transvaginal mesh (TVM), a mesh device placed transvaginally, to treat conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Since TVM’s release on the market, tens of thousands of lawsuits have been filed against various manufacturers after women began coming forward with severe complications from the medical device.
What types of complications is TVM causing?
Women have come forward with multiple painful and serious complications after undergoing surgery with TVM. “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” stated William Maisel, M.D., M.P.H., chief scientist at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. Below are just some of the side effects that have been reported.
- Erosion through vaginal epithelium
- Debilitating pain
- Urinary problems
- Injuries to nearby organs
- Prolapse and incontinence
- Bowel, bladder, and blood vessel perforation
“In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia,” the FDA noted. The complications are painful and can be permanent, and significantly hinder victims’ lives.
What are victims doing about it?
Unfortunately, far too many women have suffered major complications as a result of TVM. Victims are coming out of the woodwork and suing for recovery. While no amount of money will erase their pain or undo their hardship, many victims are in dire need of funds to seek treatment for the host of complications from which they are suffering. By filing a suit, they may recover their medical expenses, as well as other damages such as for lost wages, pain and suffering, and reduced quality of life.
To date, lawsuits have been filed against several TVM manufacturers, such as:
- Boston Scientific Corp.
- Johnson & Johnson’s Ethicon division.
Because so many lawsuits for TVM complications have arisen, manufacturers are facing mass tort claims – including one of the biggest U.S. mass torts in history, according to Reuters. Many of the companies have settled with victims and issued substantial checks. Other cases have gone to court and victims have won millions of dollars in damages. Many more lawsuits are expected as victims around the country continue to complain of complications.
How does TVM cause injuries and complications?
Transvaginal mesh can cause injury during the procedure itself, as a result of coming into contact and damaging nearby organs and structures within the body, and as a result of chemical reactions catalyzed by the mesh.
TVM is a synthetic material, essentially a foreign object that the human body may not assimilate well. One TVM patient, Lana Keeton, became exceptionally knowledgeable on this topic during the process of suing Johnson & Johnson in 2007 after she almost died from complications.
While she ultimately lost the suit in federal court because she could not prove causation, she has since become a major advocate for TVM patients like herself. She has compiled a great deal of research on mesh and created an online information and support group, Medical Mesh, which thousands of women have joined.
“Despite extensive studies written by experts about the horrific complications of synthetic surgical meshes, transvaginal mesh is still being used. Commercialization of surgical mesh by multi-billion dollar pharmaceutical giants has substituted ‘surgical mesh kits’ for good surgical skills,” Keeton noted.
She noticed a common denominator in many of the women experiencing complications: migraines, allergies, and autoimmune disorders. After conducting large amounts of research, Keeton found a link between autoimmune diseases and a chemical found in the mesh. “I discovered that this mesh is flawed on every level—physical, chemical, and how it is processed. A lot of manufacturing flaws are inherent and I know that from working in the steel industry,” she said.
Because most TVM is petroleum-based, a chemical that does not belong in the human body, the body tries to expel it in any way it can. “The human body cannot expel synthetic surgical mesh. Medical device manufacturers know this, yet use of synthetic surgical mesh is a fatally flawed concept which remains unchallenged,” Keeton lamented.
What are some possible grounds for suing a TVM manufacturer?
There are three different legal theories which may form the basis to file a suit against a TVM manufacturer.
- Breach of warranty
- Negligence: You have to prove the manufacturer was somehow careless, made mistakes, or committed wrongdoing in the manufacturing, promotion, or production of the product. For example, if they knew about but hid serious inherent risks of their mesh products, that would be grounds for a negligence suit.
- Strict liability: You do not have to prove manufacturer negligence; only that the product itself is faulty. If you can prove that the product was defective or unreasonably dangerous, you might be able to successfully pursue your case against the manufacturer.
Most cases against TVM manufacturers are based on negligence or strict liability.
Proving liability and building a strong case is an extremely complex and arduous feat – especially when it involves going head-to-head with Big Pharma and medical manufacturing giants. Contact a personal injury attorney at Cordisco & Saile LLC that handles cases of this nature to help you navigate your claim.
Do I have a valid suit so I can seek recovery for my injuries?
In order to have a valid suit, you not only have to be able to prove the manufacturer’s negligence or that the product was defective, but you must also establish “causation.” Causation is a fundamental element of a personal injury case in which you prove that the manufacturer’s negligence or the defective device actually caused your injuries.
A good number of women have lost their cases against TVM manufacturers because they have been unable to successfully prove that there is a link between TVM and the harm they have suffered. Speculation and hearsay is not sufficient; you must have medical proof and testimonies from medical field experts to substantiate your case and establish causation.
You will need to start working with a Bucks County personal injury attorney as early on as possible to collect data, talk with experts, and compile a storehouse of proof to satisfy causation and show the courts the damage this dangerous product has done to you.
What do I do if I think I have been injured by transvaginal mesh?
If you are experiencing pain and other symptoms you think are related to your TVM, get a medical evaluation and seek treatment right away. Keep records of all of your appointments, evaluations, diagnoses, and treatments, and jot down notes and input from your doctors on each visit. Also, begin an injury journal to document your symptoms and pain levels each day. All of these items can support your case if you decide to move forward with a lawsuit.
Speak with an attorney at Cordisco & Saile LLC for legal representation and help pursing the money that you are entitled to for your harms. Call Cordisco & Saile LLC to schedule a free legal consult. Contact our office at 215-642-2335 to discuss your case today.