Transvaginal mesh surgical implants have resulted in serious health complications, affecting tens of thousands of women across the country. In many circumstances, women who have undergone vaginal mesh implants are not aware of the serious health risks associated these dangerous medical devices. Complicating matters is that the harm caused by vaginal mesh can take years of recovery, cost tens of thousands of dollars and require the undergoing of multiple medical procedures. What’s more, transvaginal mesh injuries can have a permanent physical and psychological impact. Injured victims are entitled to just compensation for their injuries. If you have been injured, contact a transvaginal mesh attorney for a free case evaluation.
Background and History of Tranvaginal Mesh Injury Claims and Lawsuits
Transvaginal mesh is a product used to reinforce the vaginal wall in cases of Pelvic Organ Prolapse (otherwise known as Pelvic Floor Collapse) and Stress Urinary Incontinence. The product is produced using a polyester or polypropylene material. The product is implanted into the female uterus in order to support the vaginal wall.
In the 1970′s, gynecologist started to use surgical mesh in order to reinforce the vaginal tissue in order to treat or prevent pelvic organ prolapse. Pelvic organ prolapse, occurs when the supporting tissue between organs deteriorates or becomes weak. This commonly occurs after child birth, although there are other causes.
During the early 1990′s, surgeons started to use the surgical mesh, which was originally implanted in order to serve as a supporting mechanism for abdominal hernias, to treat SUI, or stress urinary incontinence. Transvaginal mesh was intended to prevent this issue from occurring. SUI occurs after pregnancy and can cause urinary leaks. As a result, physicians and surgeons used transvaginal mesh as a method to prevent or stop this type of issue. The device was marketed in the as a way to stop and prevent the embarrassing issues of SUI.
In turn, hundreds of thousands of woman signed up or elected to have the implants. In fact it is reported that over 250,000 woman elect to have this procedure conducted annually.
Capitalizing on the demand for the product the manufacturers of the product sold and marketed the product by using the 510(k) approval process. According to the 510(k) process certain classes of medical products can be sold or marketed without FDA approval.
Currently there are three classes of medical devices. Class I devices are those which are considered “low risk”. Manufacturers of such devices are only required to give the FDA a 90 day notice before beginning to market the product. Class II products are those which require special oversight in order to assure consumer safety. Transvaginal mesh was categorized as a Class II product and gained market access through the use of 510(k) process. Class III medical devices are those which lack sufficient evidence to show their safety. These Class III devices require special controls and premarket approval before they are permitted to be sold. Additionally these types of products cannot be use the 510(k) approval process.
This process-510(k)-circumvents or avoids the heavily regulated FDA process. Rather by using 501(k) approval process the marketers of transvaginal mesh, including Johnson & Johnson and others were able to sell the product without stringent oversight. Marketers of the product improperly asserted that their product was substantially similar to the FDA approved product known as ProteGen, thus gaining approval through the 510(k) process. However the FDA approved PorteGen product was subsequently recalled after issues were found, particularly vaginal tissue erosion.
While ProteGen was removed from the market in 1999, other marketers of transvaginal mesh continue to market and sell the product to date. These companies are aware of the potential complications, particularly because they based their model and design after that of ProteGen. To date there are over 150 different transvaginal mesh devices which are approved through the 510(k) process.
Vaginal Mesh Injury Statistics
Transvaginal mesh implants are conducted each year. Important statistics include:
- Statistical data has shown that over 250,000 procedures take place annually.
- There are over 150 different transvaginal mesh devices marketed and sold each year.
- While estimates show that 10% of patients suffer from complications within a single year of surgery, other estimates show complications in as high as 20% of patients.
- Repairing the damage done by these procedures can be both emotionally and physically draining. Surgical procedures are often required to repair and remove the implant and many patients face permanent damage.
- Common issues associated with mesh erosion can be infection, mesh contraction, bleeding, urinary issues and organ peforation.
- In the years 2008-2010 there were over 2,500 reports of complications from tansvaginal mesh made to the FDA and the FDA reported and warned of these issues to health care providers.
- Evidence indicating that transvaginal mesh implants are as effective as other traditional procedures have not been shown. Rather traditional methods are considered a better alternative.
- Studies have shown that the mesh erosion can occur in as little as 3-months after surgery, thus long term exposure can more likely than not cause erosion.
Common injuries and medical complications associated with Transvaginal Mesh Implants: TVM Side Effects
Mesh implants can result in serious medical complications some common injuries include the following:
- Erosion of the Vaginal Mesh through the vaginal mucosa
- Severe pain and discomfort during sexual intercourse
- Vaginal Infections and vaginal bleeding
- Urinary and bladder control issues
- Vaginal Contraction and shrinkage
- Bowel incontinence
Lawsuits for Defective Transvaginal Mesh
Those injured as a result of such implants are without a doubt entitled to compensation for their injuries. The scope of injuries can be serious to moderate. However the psychological impact and the potential financial cost may warrant the filing of a vaginal mesh injury lawsuit.
Transvaginal mesh lawsuits are filed under a product defect theory. A product liability claim for transvaginal mesh requires a qualified product liability attorney. In order to bring a cause of action for a defective product the injured party needs to show the following elements:
- Defendant or manufacturer of the product was engaged in business of selling such a product;
- The product was used in its intended or foreseeable manner, causing injury;
- Product was defectively designed;
- Defendant was responsible for designing the product defectively; and
- Because of the defective design injuries occurred.
This is one of many different methods of establishing a cause of action for your case. It is also possible to assert a cause of action of a negligent design of the product or event a breach of an implied warranty. These different theories should all be consulted with a qualified transvaginal mesh attorney.
What to do if you have sustained complications and injuries from Vaginal Mesh Defects
There are number of steps which should be taken if you feel that your injuries are a result of a transvaginal mesh implant. First, you should contact your physician and get a proper opinion; often times they can determine the cause of your discomfort. Second, gather all necessary files including your medical information, communications between your physician and other information you have which you feel may be relevant. Third, contact a transvaginal mesh attorney. Seeking legal representation is important. Companies responsible for the manufacturing and distribution of these products will not settle with you directly. Rather you need an attorney to handle your case and obtain a viable settlement for your injuries.
Filing a Lawsuit for the Death of a Family Member from Transvaginal Mesh Implants: In some instances serious side effects associated with Transvaginal mesh implants, will result in death. Relatives of victims have the right to monetary recovery based on a Wrongful Death cause of action against manufacturers and distributors of medical implants. Jurisdictions across the United States have various restrictions regarding individual who may be permitted to file a wrongful death claim. For instances, under California Wrongful Death Code of Civil Procedure Section 377.60-377.62 a cause of action for wrongful death can be asserted by the decedent’s surviving spouse, domestic partner, children, and issue of deceased children, or, if there is no surviving issue of the decedent, the persons, including the surviving spouse or domestic partner, who would be entitled to the property of the decedent by intestate succession.
Do I have a Transvaginal Mesh Injury Claim – Vaginal Mesh Defect Attorneys
Downtown L.A. Law Group deals with product liability cases and Class II medical device defects. If you have been injured contact our offices today for a free case evaluation. We will conduct a thorough analysis and review of your claim. Our attorneys can help you better understand your case and help you obtain the compensation you deserve.
List of Tranvaginal Mesh Producers and Manufactures:
The following is a list of mesh device manufacturers. If you have sustained complications resulting from any of these mesh devises contact our law firm.
American Medical Systems: Visit This Page for more information on American Medical Systems (AMS) Vaginal Mesh Litigation
- Bio Arc
- Monere subfascial hammock
- Intepro Y Sling
- In-Fast Ultra
- Elevate with Intepro
- American Medical Systems AMS SPARCO
- Advantage Fit
- Advantage Sling System
- Lynx Suprapubic Mid-Urethral Sling System
- Obtryx Curved Single
- Obtryx Mesh Sling
- Pinnacle Pelvic Floor Repair Kit
- Pinnacle Pelvic Floor Repair Kit II
- Polyform Synthetic Mesh
- Prefyx Mid U Mesh Sling System
- Prefyx PPS System
Johnson & Johnson also called Ethicon: Visit this page For more information on Ethicon Vaginal Mesh Lawsuits
- Gynecare Prolift Kit
- Gynecare Prolift + M Kit
- Gynecare TVT Secure
- Gynecare Prosima Pelvic Floor Repair
C.R. Bard: Visit this page For more information on C.R. Bard Inc. Vaginal Mesh Litigation
- Avaulta Plus BioSynthetic Support System
- Avaulta Solo Synthetic Support System
- Faslata Allograft
- Pelvicol Tissue
- PelviSoft Biomesh
- Pelvitex Polypropylene Mes
- Ugytex and Ugytex Dual Knot Mesh
Other Vaginal Mesh Producers
- Tyco – IVS Tunneller
When you contact our Law Firm a Transvaginal Mesh Injury Attorney will immediately field your call and provide you with a detailed in depth consultation regarding any possible claims against medical device manufactureres. Our phone number is (855)385-2529.