We Represent Hundreds of Victims of Transvaginal Mesh Injury Nationwide 1-855-MESH-LAW
Now Accepting Claims for Transvaginal Surgical Mesh Injuries
Approximately 750,000 transvaginal surgical mesh patches were implanted each year. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place.
An initial recall was announced in December 2005, but additional mesh products were not added to the recall until March 2006 and January 2007. The FDA has classified the mesh since the product carries a reasonable probability of causing serious adverse health complications, including death because of the piercing of the broken mesh or coils through body organs.
Common complications are as follows:
If you have suffered any of these complications listed or any other that is not, please fill out the claim form on the side of this page and one of our attorneys will evaluate your case.
You should be aware that sometimes injuries related to mesh are mistaken for other types
of injuries. In particular, one of the injuries common to some mesh products used to treat stress
urinary incontinence – damage to nerves as a result of the procedure used to implant the mesh
product – is often mistaken for unrelated back, thigh or hip pain. If you experience pain in any
of these areas following surgery for stress urinary incontinence or if you experience tingling,
numbness, sexual, bowel or bladder dysfunction, it is very important that you discuss your
symptoms with your doctor.
The third vaginal mesh trial recently concluded with a West Virginia jury finding in favor of the plaintiff, Donna Cisson. Mrs. Cisson was implanted with a Bard Avaulta pelvic organ prolapse mesh kit. Mrs. Cisson was forced to suffer through corrective surgeries and permanent pelvic floor pain. The jury awarded Mrs. Cisson $250,000.00 in compensatory damages and $1.75 million in punitive damages. Prior to Mrs. Cisson's trial, two previous verdicts were reached in the Scott and Gross cases. In the Christine Scott case, she sued Bard relating to the implantation of an Avaulta pelvic organ prolapse kit. The case went to trial in California and jury awarded 5.5 million in damages with 60% of the liability assigned to Bard and 40% assigned to Ms. Scott's implanting surgeon. In the Linda Gross case, she sued Ethicon/Johnson & Johnson relating to the implantation of the Prolift pelvic organ prolapse device. Mrs. Gross was forced to endure eighteen corrective surgeries as a result of the defect in the Prolift and has been left with permanent, debilitating pain. The case went to trial in Atlantic County, New Jersey state court and the jury awarded $3.35 million in compensatory damages and $7.76 million in punitive damages. The Cisson, Scott and Gross verdicts have all been appealed by the defendants.
Composix Mesh Patch Has Been Recalled
The Composixl Mesh Patch is manufactured by Davol, Inc., a subsidiary of C.R. Bard, Inc. The following products have been recalled:
FDA News Release
The U.S. Food and Drug Administration issued an updated safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.
The safety communication also says that with the exposure to greater risk comes no evidence of greater clinical benefit such as improved quality of life.
Pelvic Organ Prolapse (POP) occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.
Surgery to repair POP can be performed through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy.
”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
In 2010, there were at least 100,000 POP repairs that used surgical mesh. About 75,000 of these were transvaginal procedures.
The FDA issued a safety communication in 2008 due to increasing concerns about adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has continued to climb. From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007. The reports don’t always differentiate between transvaginal and abdominal procedures.
The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.
The FDA also conducted a review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries. The agency review suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks, compared to patients who undergo POP repair with stitches alone. While mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries.
FDA recommends that health care providers:
• Recognize that in most cases, POP can be treated successfully without mesh;
The FDA recommends that patients:
• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
The FDA also announced that an outside panel of experts in obstetrics and gynecology will meet on Sept. 8-9, 2011, to discuss the safety and effectiveness of surgical mesh used to treat POP and stress urinary incontinence (SUI), a leakage of urine during physical activity. The panel will discuss the risk of transvaginal POP repair, clinical studies that may be necessary to address risks and benefits of this type of surgery, and the FDA’s interim recommendations for health care professionals and patients.
“Input from the clinicians, manufacturers and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for POP and SUI repair, including any changes that would improve our oversight,” Maisel said.
Today’s safety communication is limited to the transvaginal placement of mesh to repair POP. It does not address the safety and effectiveness of mesh used to treat SUI or mesh implanted abdominally.
For more information:
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
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