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.
Cook Medical and Allegations Against
In or about 1999, Cook Group, Inc., by and through its subsidiary Cook Biotech, Inc., began to market and sell products for the treatment of medical conditions in the female pelvis, primarily pelvic organ prolapse and stress urinary incontinence. Cook sought and secured 510K clearance on the following medical devices indicated and/or sold for the repair or restoration of stress urinary incontinence: Surgisis Biodesign Urethral Sling on September 23, 1999 and Surgisis Biodesign Tension-Free Urethral Sling on April 9, 2002.
Cook sought and secured 510K clearance on the following medical devices and/or sold for repair or restoration of pelvic organ prolapse: Surgisis Biodesign Anterior Pelvic Floor Grafts; and Surgisis Biodesign Posterior Pelvic Floor Grafts; and Surgisis Biodesign Vaginal Erosion Repair Graft.
Cook’s products were derived largely from hernia mesh products and are utilized in the treatment of medical conditions in the female pelvis, primarily pelvic organ prolapse and stress urinary incontinence. Cook, in fact, has made the following assertion regarding its product. Surgisis design is not a new graft or mesh but a whole new category in the evolution of tissue repair. A breakthrough technology, it incorporates the best attributes of biologic graft, resistant to infection and complete remodeling, with the added benefits of moderate price, ease of use and widespread availability.
Cook has further asserted about their biodesign products “in unlike synthetic mesh, nothing is left permanently in the body to cause problems down the road.” On August 20, 2011, Cook issued a communication to the FDA in advance of the September 2011 advisory committee hearings regarding the investigation into the risks associated with mesh for stress urinary incontinence and pelvic floor repair and/or pelvic floor prolapse. In its communication, Cook asserted regarding its non-cross linked biologic matrix that “any inflammation is localized in regions where small remnants of the synthetic suture used to affix the graft remain.”
Contrary to Cook’s assertions that its products are resistant to infection, result in complete remodeling, are limited in inflammatory response to areas where synthetic sutures are/were utilized during surgery and will not cause any problems down the road, the following non-inclusive literature suggests otherwise:
- In November of 2005, results from a study were published in the International Journal of Obstetrics and Gynecology relating to the comparison of the host response, architectural integration and tension strengths of polypropylene to portion small intestine, submucosa-derived implants including Cook’s Products. Implants from the SIS group showed a short term increase of thickness in the first 14 days. Formation of adhesions was significantly more extensive in the SIS group at 90 days. Tension strength increased over time in both groups but was significantly lower in the SIS group. Implants in the SIS group showed inflammatory response.
- In October of 2008, results from a study were published in the Archives of Gastroenterology relating to the comparison of the repair of induced abdominal wall defects with Cook’s Surgisis Mesh and Covidien, Inc.’s Parietex. Both meshes induced skin erosions. There were paraneal adhesions to the surface of both types of meshes after 30 and 60 days. Meshes shrink and correspond to 1/3 of the original size and parietex caused less inflammatory process at the histologic evaluation.
- In November of 2008, results from a study were published in Urology relating to reports of intense local and inflammatory reactions in patients undergoing pubovaginal sling or tape using a small intestinal graft. After implantation of 16 standard pubovaginal sling or tension-free tape procedures for stress urinary incontinence, using the Cook 4-ply stratasis or 8-ply stratasis-TF system, 31.3% had intense pain after surgery. One patient had undulation of the mons pubis that required surgical drainage. One patient had vaginal inflammation, with expulsion of graft material. Other patients had intense sheaf inflammation as confirmed on CT scan. This study confirmed previous case reports of inflammantory complications of small intestinal submucosa leading to the institution and cessation of use of Cook’s Products.
- In January of 2009, results from a study were published in the Journal of Biomedical Materials Research Part B relating to the evaluation of Cook’s Surgisis Gold to other materials including CR Bards, Permacol, Epicon’s prolene mesh and life cells alederm in the context of human cells. The result of the study indicates that Surgisis Gold to inferior in aiding in the growth and activity of human cells than other products.
- In October of 2011, results from a study were published in the Archives of Gastroenterology relating to the comparison of different biologic materials regarding relevant implant integration, shrinkage and foreign body reaction. Relating to Cook’s Products the integration of its product was insufficient and could detach easily from the underlying tissue, the penetration of fiber blasts and vessels was limited, foreign body reaction was pronounced, leading to persistent inflammation, and shrinkage was excessive in comparison to all other products.
- In February of 2012, results from a study were published in Hernia relating to the comparison of different biologic meshes including Cook’s Surgisis Gold regarding the relative performance and efficacy as between two non-cross linked meshes and two cross-linked prosthesis. Major complications seen with Cook’s Products included that it appeared to be wrinkled and faulted by excessive shrinkage eliciting severe adhesions and a pronounced local inflammation characterized by foreign body giant cells.
- In September of 2012, results from a study were published in Biomaterials relating to the clinical performance of biomaterials in the context of competing leukocyte activation by commercially available biologic surgical materials and define the extent manufacturing variables influence downstream response. The data demonstrated that Cook’s Products showed excessive leukocyte activation and was significantly more pro-inflammatory as compared to other products analyzed. High degrees of leukocyte activation led to poor material and patient compliance accelerated degeneration and graft rejection.
Cook’s Products have been and continue to be marketed to the medical community and to patients as safe, effective and reliable medical devices implanted by safe and effective minimally invasive surgical techniques for the treatment of medical conditions primarily pelvic organ prolapse and stress urinary incontinence. Marketing campaigns have included but are not limited to direct consumer advertising, aggressive marketing to healthcare providers at medical conferences, and include the provision of valuable consideration and benefits to healthcare providers. Cook has utilized documents, brochures, websites, and telephone information lines often exaggerating and misleading the expectations as to the safest and utility of their medical products. Contrary to their representations and marketing, lawsuits have been filed alleging that Cook’s pelvic mesh products have high failure, injury and complication rates, fail to perform as intended, require frequent and often debilitating re-operations, and have caused severe and irreversible injuries, conditions and damage to a significant number of women.
It is alleged that Cook has consistently under reported and withheld information about the propensity of its mesh products to fail to cause injury and complications and have also misrepresented the efficacy and safety of its products through various means and media actively and intentionally misleading the FDA, the medical community, patients and the public at large.
Feasible and suitable alternative designs as well as suitable alternative procedures and instruments for implantation and treatment of stress urinary incontinence, pelvic organ prolapse and other conditions have existed at all times relevant as compared to Cook’s pelvic mesh products. In fact, it is alleged that Cook has at all times provided incomplete, insufficient, and misleading training and information to physicians in order to increase the number of physicians utilizing their mesh products and thus increased the sales of the products. More so, there are a number of injuries and conditions including complications that can be suffered due to Cook’s medical products including but not limited to colon mesh erosion, mesh contraction, infection, distilla, inflammation, scar tissue, organ perforation, blood loss, neuropathic and other chronic nerve damage and pain, nerve damage, pelvic floor damage, pelvic pain, urinary and fecal incontinence, prolapse of organs, and intensive medical treatment including but not limited to operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue and nerve damage, pain control, injections into various areas of the pelvis, spine and the vagina, and operations to remove portions of the female genatalia.
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 :
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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.