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, C.R. Bard, Boston Scientific, Coloplast, and Johnson & Johnson / Ethicon. 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.
TVM Lawyer and TVM Side Effects
Transvaginal Mesh Implant Injuries: The Common Side Effects
Synthetic mesh devices are implanted transvaginally using surgical procedures to provide support to and uplift prolapsed pelvic organs in women. However, the side effects and complications caused by these devices in patients using them overshadow their efficacy. The FDA has put transvaginal mesh implants into “Class II” category which is assigned to medical devices with the potential to cause intermediate risk in users. The MedWatch system was flooded with more than 2,900 reports of injuries caused by transvaginal mesh implants between 2008 and 2010 after the federal regulator admitted potential side effects of these devices. A number of independent research studies have also highlighted irreversible complications associated with these vaginal mesh implants.
Studies on Transvaginal Mesh Implant Injuries
- Findings of a research reported in August 2010 that Gynecare Prolift transvaginal mesh implants, the most sold brand of mesh devices, did not offer any significant benefit over traditional methods to treat pelvic organ prolapsed. The report published the American Journal of Obstetrics and Gynecology highlighted that 15 percent women implanted with them experience these devices complained of erosion within a short period of time.
- In August 2011, another report in the journal disclosed that these transvaginal mesh implants led to reoperation and additional surgeries in more than 12 percent of users. The report was based on a two-year study carried on by European researchers.
- Public Citizen demanded withdrawal of transvaginal mesh implants in August 2011 citing complications, such as urinary problems, recurring of prolapsed, pelvic organ punctures, infections, and other side effects. According to its “Do Not Use” advisory, mesh implants “needlessly expose patients to serious, life-altering complications.”
- In December 2011, the Committee on Gynecologic Practice, a body representing all associations of gynecologists and obstetricians in the country asked medical practitioners to restrict the use of mesh implants to the most essential cases. It cited high risk of mesh shrinkage and complications leading to health hazards in users as the reason.
- In early 2012, a group of House Democrats demanded a Congressional hearing on the side effects of transvaginal mesh implants.
FDA Warning on Injuries
In 2008, the FDA admitted of receiving hundreds of consumer complaints about adverse complication risks caused by mesh implants. In the next two years the number of complaints increased fivefold forcing the FDA to review all mesh implant surgeries done since 1996.
The FDA issued an alert in July 2011 on the side effects of vaginal mesh implants. The key points mentioned in the alert highlighted
- Risk of pelvic organ punctures caused by vaginal mesh implants
- Risk of additional surgeries caused by erosion of vaginal mesh implants
- Risk of irreversible and permanent complications caused by vaginal mesh implants
- Risk of infections and complications not present in other type of treatment
- No significant benefit over non-mesh surgeries
- Mesh implant-induced pain and shortening of vagina
The FDA asked all 33 manufacturers of vaginal mesh implants to restart safety assessments and clinical trials on the side effects reported by independent sources and consumers. The order issued in January 2012 called for 88 post-marketing studies on vaginal mesh implants and 11 post-marketing studies on mini-slings used in pelvic organ prolapse surgeries.
The order led to market withdrawal of a number of Gynecare mesh implants after Johnson and Johnson subsidiary Ethicon recalled them from the market saying that retesting and post-marketing studies are commercially unviable. Gynecare mesh implants has 70 percent market share in the United States.
Reported Transvaginal Mesh Implant Injuries
Transvaginal mesh implants can cause medium to sever complications that are irreversible and can impact the quality of life of users. The most reported injuries include the following.
- Mesh implants cause chronic pain that even continues after their removal. Women implanted with these devices reportedly experienced pain during sex. Shrinkage of mesh devices also leads to shortening of the vagina and constant pain.
- Early erosion of the mesh exposes the devices and they can be visible on the pelvic surface. Erosion also leads to failure of the device and requires reoperation of patients to fix their pelvic floor prolapse.
- Women implanted with transvaginal mesh devices are more likely to suffer from infections and complications that are not present in those undergoing alternative treatments.
- Common complications caused by these mesh implants include car discomfort, perforation of bladder, vagina, uterus, urethra, and pelvic membrane, vaginal bleeding, and scar pelvic tissue development.
- Chronic infection caused by the mesh implants includes inflammation of pelvic organs.
- At least 10 percent of women implanted with devices have complained of failure of devices within a year of the implant surgery. Erosion is found to be most important cause of device failure.
- Perforation of vaginal wall is another major side effect of vaginal mesh implants. A number of patients had to undergo additional surgeries to treat impact of surgical excision on other organs.
- Abdominal pain and urinary problems are among the most reported mesh implant side effects.
- Failure of mesh implants caused by erosion results in recurrence of pelvic organ prolapse.
Our team of attorneys are currently representing more than 100 women who claim to have suffered similar injuries as a result of using pelvic mesh products. Please continue reading for more help.
Do You Qualify for a Transvaginal Mesh Lawsuit?
Recently, the public has become aware of serious health complications suffered by women after undergoing surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI) with transvaginal mesh devices. According to the U.S. Food & Drug Administration (FDA), between January 2008 and December 2010, there were nearly 3,000 adverse event reports involving transvaginal mesh devices. Specifically, there were 1,503 reports of complications involving POP repair and 1,371 reports linked to surgery for SUI. Our team of lawyers are representing women who experienced both complications.
Side effects reported in transvaginal mesh recipients include:
- Infections
- Internal bleeding
- Vaginal scar tissue
- Vaginal wall narrowing
- Painful urination
- Fistulas
- Mesh shrinkage
- Mesh migration
- Urinary problems
- Punctures to the bladder, blood vessels, bowels or other organs in the lower abdomen
- Mesh erosion into the vagina, bladder, intestines, and uterus
- Pain
- Painful sexual intercourse for both partners
- Recurrence of incontinence
- Recurrence of both POP and SUI, or both
Numerous lawsuits have been filed over these complications, in part because studies have shown that transvaginal mesh offers no real benefit over safer, more traditional methods of treatment. Making matters worse, in many cases the POP or SUI the implant was supposed to fix in the first place returns. Transvaginal mesh manufacturers took advantage of the FDA’s highly criticized 510(k) approval process, which allows medical devices to be sold on the market without ever being safety tested in humans. Now, thousands of innocent women are paying the price.
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, Johnson & Johnson’s Ethicon, and Coloplast.
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, Coloplast, 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
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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.