FREE CASE EVALUATION: 1-800-632-1404
Tens of thousands of women receive a transvaginal mesh (TVM) device each and every year from numerous suppliers: American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson. Thousands of women have been injured through no fault of their own, including vaginal erosion, pain, urinary problems, bleeding, infection and more. Our attorneys are representing women in all fifty states and Canada who have been injured. For a free case evaluation, call 1-800-632-1404.
We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.
FDA Issues Mandate
The FDA issued a mandate this week requiring the manufacturers of transvaginal mesh (TVM) products, including American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson, to study the risks and complications of device usage. As a service to the public at large, these are four separate news sources reporting on this pandemic that is affecting thousands of women.
Increased reports of complications have prompted the US Food and Drug Administration (FDA) to order new postmarket surveillance (522) studies of surgical mesh implants used to treat pelvic organ prolapse and stress urinary incontinence.
The FDA is also considering reclassifying urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse from Class II to Class III, a higher-risk category that would require clinical trials before approval.
Under the new FDA order, manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for prolapse and single-incision mini-sling devices for stress incontinence. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices.
The FDA said it continues to assess the safety and effectiveness of urogynecologic surgical mesh devices through the following additional actions:
- Review and analysis of published literature, Medical Device Reports submitted to the agency, and post-approval study reports
- Epidemiologic research on safety and effectiveness of surgical mesh
- Collaborations with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, as well as the occurrence of and signs and symptoms associated with specific adverse events
- Collecting and reviewing all available information about currently marketed urogynecologic surgical mesh devices.
This issue has been reported by Modern Medicine.
To date, the FDA has not released these mandates, but as soon as they are issued, you can be assured this website will post for the world to see.
Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.
If you need help from a transvaginal mesh device injury, call us today for help.
The Problem
In 2008, the FDA first released concerns about the safety of transvaginal placement of mesh. From 2008 to 2010, the FDA received three to five times as many adverse reports associated with mesh used for pelvic organ prolapse repair than what agency received from 2005 to 2007 (nearly 1,000 reports of adverse events were received from 2005-2007).
Many of these patients complain because of erosion or contraction of the mesh material (which has been described as being of a similar material as Rubbermaid storage containers). The erosion leads to bleeding, severe pelvic pain, painful (or impossible) sexual performance and a recurrence of urinary problems.
In July 2011, the Food and Drug Administration (FDA) issued an update related to what it called ‘serious complications’ related to the use of vaginal mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is now known that complications linked to transvaginal placement of surgical mesh in SUI and POP patients are not rare and can require multiple surgeries to correct problems related to the use of surgical mesh. In fact, the FDA now says that additional surgeries may actually not be able to repair damage caused by implantation of the mesh.
In other words, the side effects of the mesh placement may be permanent. These complications from transvaginal placement of surgical mesh include:
- -Erosion of the implanted mesh
- -Infection and/or bleeding
- -Pain, including pain during sexual intercourse
- -Problems with organs near the implantation site
Helping You
You may have experienced mesh erosion, bleeding, urinary infections, vaginal scarring, pain during sexual intercourse, failure to conduct sexual intercourse and more. A physician may have tried to remove the mesh and been unable to do so. You may be in excruciating pain, and need help. We are offering free case evaluations to the general public across the United States and Canada. Manufacturers we consider include American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.
If you received a transvaginal mesh / sling and have been injured, you may be entitled to monetary compensation. Problems include pain, inability to have intercourse,bleeding, mesh growth into the body, mesh erosion, and more. Problems could be irreversible. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.
We are accepting case evaluations nationwide and in Canada, as well. Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :
CALL: 1-800-632-1404
EMAIL: clicking here
FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:
NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.