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.
Congress Involved with TVMs
In March 2005, Johnson & Johnson began marketing Gynecare Prolift, a transvaginal mesh in theUnited States. By law, before a medical device is marketed, it must be approved by the FDA. The manufacturer must get the device approved by the through a premarket application (PMA) process or through the 510(k) process. Gynecare Prolift received FDA approval only in 2008. Johnson and Johnson claimed that it did not need FDA approval because the device was based on similar devices already in the market.
Medical Device Amendments of 1976 established three risk classes for all medical devices, Classes I (for example, stethoscopes, crutches, cold packs), II (for example, hearing aids, powered wheelchairs, many lab tests), III (for example, infant breathing monitors, replacement heart valves, bone cement). Class I devices are subject only to minimal regulation. Class II devices can be marketed without advance approval but are subject to more rigorous controls. Class III devices devices must obtain FDA approval through a rigorous PMA process before marketing the device. In a PMA, the device manufacturer must provide FDA with a reasonable assurance that the device is both safe and effective, a process somewhat akin to an NDA submission.
Eventually, FDA was to generate specific marketing requirements for all types of devices, both new devices and those on the market prior to 1976. However, many medical devices on the market today have not received premarket approval because FDA has lacked financial and other resources to both handle the increasing number of PMA submissions and to promulgate new PMA requirements. As a result, the 510(k) premarket notification process is still often the means by which new medical devices, including Class III devices, are approved for the market. Most device manufacturers do not complain about this situation since, compared to the PMA, the 510(k) notification process takes much less time to prepare, requires much less information, gets processed very quickly, and has a low rejection rate.
New legislation called the Safety of Untested and New Devices Act is being introduced to deal with this loophole. The transvaginal mesh is one of the many medical devices that received approval through the 510(k) process and is seen as the catalyst behind the new legislation.
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.