Transvaginal Mesh
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The FDA Warns of Serious Complications with Transvaginal Mesh Patches
In 2008, the FDA warned doctors that transvaginal placement of surgical mesh products generated more than 1,000 reports of adverse events. And late last year the The American College of Obstetricians and Gynecologists published the results of a two-year clinical study that found "no difference in overall objective and subjective cure rates" between women who received vaginal colpopexy repair with the mesh and those who received the treatment without mesh. The report also found that women who received the mesh experienced "a high vaginal mesh erosion rate".
In fact, the researchers brought the clinical trial to an early close in late 2009 because the side effects being reported were too severe to continue research. Over 15 percent of women in the study experienced erosion.
Some women have experienced painful mesh erosion, in which the skin splits and the mesh protrudes, and contraction of the mesh, leading to vaginal shrinkage.
Several manufacturers market vaginal mesh, including Ethicon/Gynecare/Johnson, Johnson and C.R.Bard, Inc and the Mentor Corporation.
OVERVIEW:
As the number of transvaginal mesh lawsuits against mesh manufacturers grew, so did the pressure for the FDA to do something. Surgical procedures became more common as more women came forward to report complications. These procedures included drainage of abscesses and hematoma, IV therapy, blood transfusions, and mesh removal.The FDA issued an update to the previous notification in July of 2011. In it, the FDA reversed the previous finding of rare complications by stating that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” This followed a review of the literature, which found increased risks associated with transvaginal mesh, no evidence of added benefits in comparison with non-mesh techniques and the newly identified complication of mesh contraction. Even with this knowledge, the FDA did not initiate a transvaginal mesh recall.
How can you seek compensation?
An Experienced Law Firm Can:
- Help you recover medical expenses and lost income from all responsible parties.
- Help you obtain records, case information, legal documents and photographs related to your case.
- Track down witnesses that must be found and asked for testimony regarding your Personal Injury case.
- Guide you through each step of the legal process and will help minimize potential disruptions to your life so you can focus on your recovery.
- Provide expert witnesses that have testified in similar Personal Injury cases that will help with your settlement.
- Help educate you about your case and the state laws involved.
- Make sure that your Personal Injury case is filed within the statute of limitations for your state.
- Transvaginal Mesh (TVM) litigation is complicated and can involve large sums of money. A personal injury lawyer can make sure that you get compensation.
- Can usually tell within a few minutes whether they can help you, and if they can't, maybe direct you to someone who can.
Request a free evalualtion now to begin the process.
Our firm works on a contingency basis which means you will not be asked to pay any money out of pocket.
This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.
This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.
Transvaginal Mesh Side Effects
In 2008, the FDA issued a public health notification concerning the serious complications associated with transvaginal mesh. The FDA reported over 1,000 reports in three years of complications, including:
- Chronic pain
- Infection
- Perforation of the bladder, blood vessels and bowels during the Insertion procedure
- Erosion through the vaginal epithelium
- Urinary problems
- Recurrence of incontinence or prolapse
- Pain during sex and resulting loss of libido
- Vaginal scarring
The Four Issues Revealed by the FDA Review On Transvaginal Mesh
- Transvaginal mesh POP repair increases patient risks not found in traditional non-mesh POP repair.
- Transvaginal mesh surgery carries a higher risk of mesh complications than abdominal mesh surgery for POP repair.
- There is no evidence that using transvaginal mesh to support either the top or back wall of the vagina has any benefit to the patient over non-mesh treatment.
- There may not be any better symptomatic results when using transvaginal mesh to strengthen tissue between the bladder and vagina compared to traditional non-mesh POP repair.
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