The Transvaginal Mesh Implant: A Cure or a Curse?
Transvaginal mesh implants have raised more questions than answers in the quest for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP.) These are conditions associated with weakened pelvic muscles which cause leakage of urine or the protrusion of organs in the abdomen through the vagina or rectum.
Considering the serious nature of the SUI and POP complications, the innovation of Transvaginal mesh, a device intended for treatment, was a breakthrough; or so healthcare practitioners initially thought. Unfortunately, it turned out to be a device that complicated and compounded these conditions further. The device led to such serious issues that painful revision surgeries were necessary for some patients.
Description of the Transvaginal Mesh Implant
Polypropylene is the main material used in Transvaginal mesh implants. It is a kind of plastic that is used to manufacture the non–absorbable synthetic Transvaginal mesh implant. Other types of the device include the composite, biologic and the absorbable synthetic Transvaginal mesh implant.
The mesh is usually net-like in structure. It is referred to as Transvaginal because of the system used to implant it; through the vagina. While the device can be inserted abdominally, when it is inserted through the vagina, it is usually more accurate and efficient.
A surgeon will usually make two incisions, one through the vagina and the other in the abdominal region. Depending on the design of the Transvaginal mesh implant, the incisions may vary between two and three. The procedure is not considered a high risk surgery.
Unfortunately, the Transvaginal mesh implant has caused severe complications in most patients. It leads to erosion of the mesh, pain, bleeding, perforation of organs near the mesh, hindered normal activity such as walking and sexual intercourse and other severe health problems.
Transvaginal Mesh Implant Brands
The first Transvaginal mesh implant to be approved by the US Food and Drug Administration (FDA) was the ProtoGen, a product from Boston Scientific. It was approved in 1996. Shortly after the approval of this Transvaginal mesh, Johnson & Johnson’s subsidiary company, Ethicon had their Transvaginal device approved by the FDA. It sold under the brand name Gynemesh PS. It was the first Transvaginal mesh implant of its kind to be dedicated to solving pelvic organ prolapse (POP) disorders.
Soon after the production, marketing and sale of these products, the ProtoGen was recalled due to a series of complaints about its side effects. Other manufacturers never bothered to find out why a similar product was recalled. Or did they know and chose to ignore the warning instead?
The manufacturers continued to sell their Transvaginal mesh implant brands but now sold them as a kit. The kit came with special tools and instructions for insertion for the surgeon and the transvaginal mesh implant. The first kits were approved for sale in 1997 and were specially designed to manage SUI disorders. They were branded by American Medical Systems and sold under the brand name AMS Apogee. Soon after, kits intended to manage POP disorders were released by the American Medical systems company and sold under the brand name AMS Perigee.
Other brand names of Transvaginal mesh implants from AMS include AMS BioArc, AMS Elevate, Monarc, Mini-Arc, Straight-In mesh and SPARC.
Other companies or corporations that sell Transvaginal mesh implants include Bard that trades under the brand names of Avaulta and Uretex. Ethicon (a subsidiary of Johnson & Johnson) is another manufacturer, selling under the brand name of Gynecare Systems.
Boston Scientific Corporation sells its Transvaginal mesh implants under several brand names. The brand names include: Prefix PPS Systems, Obtryx Curved Single, Advantage Sling System, Obtryx Mesh Single, Uphold Vaginal Support Systems, Lynx Suprapubic Mid-Urethral Sling System and Mid U Mesh Sling System.
Covidien Company, which was originally Tyco Healthcare, sells its Transvaginal mesh implants under the brand name IVS Tunneller. There are other Transvaginal mesh implants sold under various brand names from other manufacturers in the market.
What Specialists in Transvaginal Mesh Implant Procedures Have to Say
A doctor who specializes in the revision surgeries that follow the first implant surgery of the transvaginal devices is usually referred to as a Urogynecologist. These doctors specialize in pelvic floor abnormalities such as SUI and POP.
An article featured in the American Journal of Obstetrics and Gynecology stated that the ProtoGen, prior to its clearance, had never been clinically implanted on a human vagina. This article was authored by Wall L. Lewis, a licensed Urogynecologist.
Shortly after the research, doctors independently carried out their own clinical trials and tests and understood the risks associated with these Transvaginal implants. This was when the FDA paid close attention to the safety of the device. The risks associated with the device were serious and could not be ignored anymore if the public’s health was to be safeguarded.
This led to the FDA issuing warnings to the public on using the device. Consumers were urged to consider other treatment options before deciding on a Transvaginal mesh implant.
The Basis of Transvaginal Mesh Implant Lawsuits
After undue pain suffering, a member of the public decided to sue for Damages. In 2012, Christine Scott and her spouse sued C. R. Bard Inc. for Damages. The jury voted in their favor and they were awarded $5.5 million for her injuries. Shortly after, Linda Gross sued Ethicon for damages and was awarded $ 11 million dollars because of having to undergo 18 revision surgeries.
These lawsuits are the bellwether cases for pending Multidistrict Litigations in West Virginia. They are cases based on a product causing harm to a consumer because of the company’s negligence.
In these cases, both parties claimed that the companies did not put the safety of the consumer before their economic interests and instead went on to sell them faulty Transvaginal mesh implants that they knew would have serious complications. While it is easy to insert the product, it is nearly impossible to remove the transvaginal mesh once it fuses with tissues and organs, thus sentencing consumers to a life of misery and repercussions they never bargained for.
Financial Compensation for Damages Caused by the Transvaginal Mesh Implant
If you have been negative impacted by one of these devices, you may qualify for financial compensation. Do not hesitate to contact our product injury attorneys for legal assistance today! Complete the form on this page today or call to speak with a legal expert today. The registration and evaluation processes that are carried out to find out whether you qualify are completely free of charge. Fees are only when you receive a payment from the manufacturer of the Transvaginal mesh implant.