Loncar Lyon Jenkins is currently filing transvaginal mesh lawsuits on behalf of victims
If you or someone you love were among those needlessly injured as a result of transvaginal mesh, you may be eligible for compensation. Loncar Lyon Jenkins is investigating cases in all 50 states. Contact Loncar Lyon Jenkins immediately for a free, confidential case evaluation using the form on the side or by calling toll free at 800.285.4878. Onglyza heart failure lawsuits are being evaluated on a contingency fee basis, meaning you pay nothing unless a recovery is obtained.
JANUARY 19, 2016 TRANSVAGINAL MESH UPDATE
On January 4, 2016 the U.S. Food and Drug Administration (FDA) reclassified surgical mesh for transvaginal repair of pelvic organ prolapse (POP) from a class II device (moderate-risk) to a class III device (high-risk). This announcement follows on the heels of previous FDA warnings regarding the risks for severe pelvic pain, infection, painful intercourse, bleeding, organ perforation, and urinary problems. The FDA has also issed a second order that will require manufacturers to submit a premarket approval (PMA) application to support the effectiveness and safety of surgical mesh for transvaginal POP repair. Manufacturers have been given 30 months to submit these PMA applications. The PMA application process is the FDA’s most rigorous investigative process where each product will be put under heavy scrutiny. These devices had previously been cleared through the FDA’s 510(k) process whereas manufacturers could bypass clinical trials and rigorous testing. Currently these decisions do not apply to the use of surgical mesh for other medical issues such as stress urinary incontinence.
TRANSVAGINAL MESH LITIGATION
Transvaginal meshes, also known as bladder slings, are medical devices implanted to treat stress urinary incontinence and pelvic organ prolapse. These devices were designed a lifetime but due to high failure rates along with their propensity to erode and cause organ damage, these devices are now having to be surgically removed from patients at abnormally high rate.
Many companies manufacture different transvaginal mesh/bladder sling devices. The meshes used most frequently and most often linked to injuries in women who receive the implanted mesh, are produced by four manufacturers in particular: J&J/Ethicon, Bard, AMS and Boston Scientific. Below you will find information on the transvaginal mesh devices made by each of these companies. All of these devices have caused serious side effects to women that have received them.
Johnson & Johnson
Johnson & Johnson’s Ethicon Women’s Health & Urology division, a New Jersey company, is responsible for manufacturing many transvaginal mesh devices. Brand names of Johnson & Johnson/Ethicon’s transvaginal mesh patches include:
- Ethicon TVT
- Gynecare TVT
- Gynemesh PS
- Prolene Polypropylene Mesh Patch
Bard is another manufacturer of transvaginal mesh patches. This company, based in Georgia, manufactures, distributes, and markets numerous medical devices. Brand names of Bard’s transvaginal mesh patches include:
- Avaulta Plus™ BioSynthetic Support System
- Avaulta Solo™ Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
American Medical Systems or AMS
SPARC® is a type of transvaginal mesh patch produced by Minnesota-based American Medical Systems. SPARC® is designed to treat stress incontinence.
AMS meshes/slings that Loncar Lyon Jenkins is litigating include:
- MiniArc Sling
- Monarc Hamock
With headquarters in Massachusetts, Boston Scientific, who has been making medical devices for over 25 years, is also responsible for making potentially defective and dangerous transvaginal mesh systems effects, some of which could be potentially fatal. Boston Scientific’s transvaginal mesh patch brands include:
- Advantage™ Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
Other mesh manufacturers include TSL Laboratories; Coloplast; Cook Medical/Cook Biotech, Desarrollo e Investigacion Medica Aragonesa, SL “DIMA”; Neomedic; and, Sepcialties Remeex.
The most common transvaginal mesh injuries reported are:
- Internal bleeding
- Vaginal scarring
- Vaginal wall narrowing
- Urinary Problems
- Mesh erosion through the vaginal tissues
- Pain during sexual intercourse
- Recurrence of prolapse, incontinence, or both
For a free legal consultation with a transvaginal mesh lawsuit lawyer serving Dallas, call 800-777-7777
Transvaginal Mesh Devices History
Transvaginal Mesh is a type of mesh that is surgically implanted to help repair stress urinary incontinence (SUI) and pelvic organ prolapse (POP). It was the 1970s, when gynecologists began using the mesh to repair these types of problems that marked the beginning of manufacturing of the specially designed products. And over the years, the mesh products have proved to be quite lucrative for the manufacturers.
Transvaginal meshes, pelvic meshes, bladder slings and bladder meshes are surgically implanted. According to the FDA, the devices have factors that can cause complications. Contributing factors to these complications may include mesh material, the shape and the size of the mesh, patient’s health, estrogen levels and the surgical procedures employed to implant the mesh. Some were recalled because they may exhibit lowered tensile strength, resulting in erosion, bleeding, pain when urinating, painful intercourse, chronic infection, bleeding and pain, and often times the need for revision surgical procedures to remove or replace the mesh implant, or repair the damage caused by the mesh to surrounding tissue.
In 2007 the FDA reported that there were associated complications with the use of Transvaginal Mesh when used for POP repair and that the numbers had risen significantly over past years.
In 2008, FDA alerted the public and healthcare providers about the higher risks associated with Transvaginal Mesh Implants when they issued a public health notification, warning patients and their healthcare providers of the complications which had been linked to the use of mesh implants in women, complications that led to the recall of the Transvaginal Mesh devices by the FDA in September of 2011.
Dallas Transvaginal Mesh Lawsuit Lawyer Near Me 800-777-7777
Reasons for complications associated with Transvaginal Mesh
The use of transvaginal mesh implants can expose the patients to complications that have very high risk when compared to other methods of surgical repair of the vaginal wall and surrounding tissue. This is according to the FDA, which has given this warning since they first stated that transvaginal mesh implants carry increased risks and side effects and that it also has no extra benefits when compared to other type of available surgical repair methods. More than 600 Transvaginal Mesh lawsuits had been filed against the manufacturers of these mesh products as of September 2011. More suits are being filed by women implanted with these products every day.
There is still time to file a lawsuit against the manufacturers of transvaginal mesh implants. This is because every person in the United States has a right to safe and effective medical treatment. Also, if someone is injured from risks that potentially could have been disclosed by the products’ of the manufactures, the person can file a lawsuit.
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Transvaginal Mesh side effects and injuries
Injuries associated with transvaginal mesh, vaginal mesh, pelvic mesh, and bladder sling/mesh include the following;
- Vaginal scarring
- Vaginal infections
- Pain during intercourse
- Vaginal bleeding
- Feeling of fullness or pressure in the lower part of the abdomen
- Urinary problems
- Reoccurrence of pelvic organ prolapse (POP) or stress urinary incontinence (SUI)
- Lower back pain
- Chronic vaginal drainage
- Feeling of protrusion from vagina
- Erosion of vaginal tissue
If you or a loved one were implanted with a transvaginal mesh medical device and have been treated for any of the symptoms above, contact my office as soon as possible at 1.800.285.4878, or use one of the options on the right to speak with a member of our Mass Torts staff.