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Category Archives: Vaginal Mesh

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FDA Proposes Change of Vaginal Mesh Classification

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According to the Federal Register (05/01/2014), “the Daily Journal of the United States Government,” the United States Food and Drug Administration has recently called to reclassify transvaginal mesh in the repair of pelvic organ prolapse, an ailment that affects about 50% of women, even if only to a small extent. The Register states that the… Continue Reading

Investigation Launched into Whether Johnson & Johnson Obstructed Justice and Tampered with Evidence by Deliberately Destroying Records

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Johnson & Johnson (J&J) executives are currently under the microscope as to whether or not they engaged in criminal activity when they “lost” documents critical to lawsuits filed against them. As we noted in previous posts, on February 4th, a federal magistrate judge ruled that Ethicon, a subsidiary of J&J, destroyed or lost documents that… Continue Reading

Ethicon and its Faulty Pelvic Mesh Devices: Destroying Valentine’s Day…and Implicating Documents

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Part I: Destroying Valentine’s Day Two weeks ago was Valentine’s Day— a holiday that is supposed to be full of romance and heartfelt encounters with those you love. For many lucky people, Valentine’s Day was exactly that this year. Countless couples across the country could be seen on dates, filling restaurants, theaters, and dance-halls to… Continue Reading

Verdict in Favor of Ethicon: No Big Win in the Grand Scheme of Things

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Over the course of the past several days, Ethicon, a Johnson & Johnson company, has crowed over the fact that it “prevailed” in a lawsuit regarding the pelvic mesh devices it manufactured and promoted. At first glance, the media headlines regarding Ethicon’s recent “triumph” are confusing, and might even make it seem like Ethicon has… Continue Reading

Study shows: Certain kinds of TVM more dangerous than others

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Pelvic organ prolapse is a common condition among aging women, characterized by the shifting of pelvic organs, which push up against the vaginal walls.  The condition may occur as a result of surgery or childbirth and oftentimes causes pain or discomfort.  One method of treating prolapse is to use a synthetic polypropylene mesh to provide… Continue Reading

Many women require re-operation after TVM use

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Transvaginal mesh (TVM) is a fairly new mesh-augmented suspension system, only becoming commercially available in 2004.  Early studies reported a promising short-term anatomical success rate of 94%.  Further studies were deemed necessary after the Food and Drug Administration reported several adverse outcomes associated with the use of these mesh kits. One such study, titled “Two-Year… Continue Reading

2013 – Study shows some vaginal mesh effective but risky

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Several studies have been conducted, evaluating the effectiveness of transvaginal mesh (TVM) usage in treating damaged vaginal tissues.  Initial studies primarily focused on the anatomical success of TVM, with less emphasis on functional outcome.  Dr. Salil Khandwala conducted a study titled “Transvaginal Mesh Surgery for Pelvic Organ Prolapse: One-Year Outcome Analysis,” published in the journal… Continue Reading

Vaginal mesh ineffective and dangerous, study shows

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Transvaginal mesh (TVM) is a mesh implant used to treat damaged vaginal tissues.  One condition TVM has been commonly used to treat is called pelvic organ prolapse (POP).  POP is characterized by weakening of the tissues that hold the pelvic organs in place, and occurs in 30-50% of women. An observational study, titled “Total transvaginal… Continue Reading

Italian research team finds high rate of complications associated with TVM

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Vaginal mesh in pelvic floor reconstruction has become more and more popular, and this is partially due to the high failure rates associated with older methods.  In an article titled “Rising Use of Synthetic Mesh in Transvaginal Pelvic Reconstructive Surgery:  A Review of the Risk of Vaginal Erosion”, written by the Department of Gynecology and… Continue Reading

Contemporary research highlights TVM dangers

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In the United States alone, over 300,000 pelvic floor reconstructions and urinary incontinence are performed.  Around 29 percent of these surgeries are reoperations.  The high failure rate of older methods gave way to the development of vaginal mesh kits in 2005.  Mesh-augmented vaginal prolapse repairs have shown to improve anatomical outcomes and are associated with… Continue Reading

Research shows significant risks associated with vaginal mesh

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There are many risks involved with re-operation after pelvic floor reconstruction.  Older methods used to treat organ prolapsed repair were associated with high rates of failure, hence newer, more safe methods such as the use of synthetic materials are being used to augment pelvic organ prolapse repair.  In a report titled “Review of  Synthetic Mesh-Related… Continue Reading

Vaginal mesh repair in POP often unsuccessful

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In 2011, the International Urogynecological Association published a study called “Prospective Study of Anterior Transobturator Mesh Kit for the Management of Recurrent Anterior Vaginal Wall Prolapse”, where the objective was the assessment of the 2 year outcome of anterior Prolift for patients with recurrent anterior vaginal wall prolapse.  Anterior wall repair is a procedure that… Continue Reading

Study shows: Transvaginal mesh is unsafe

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The objective of a study called “Outcomes and Predictors of Failure of Trocarguided Vaginal Mesh Surgery for Pelvic Organ Prolapse”, written by the department of Obstetrics and Gynecology, Reinier de Graaf Group, and the Department of Obstetrics and Gynecology at  Radboud University Nijmegen Medical Centre in Nijmegen, The Netherlands, was to compare the outcomes of… Continue Reading

Vaginal mesh found to cause complications or fail at high rate

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Pelvic organ prolapse (POP) is a major health issue, especially concerning to older women.  Women who have had multiple children have a 50 percent chance they will one day need corrective surgery, and recurrence rates as high as 70 percent have been seen after traditional vaginal prolapse surgery.  This has caused many doctors to recommend… Continue Reading

“Synthetic Vaginal Mesh for Pelvic Organ Prolapse” Shows: Mesh is Dangerous

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In 2004, the FDA cleared the use of synthetic vaginal mesh delivery systems.  The high failure rates from traditional vaginal colporrhaphy and apical suspension procedures using native tissue is what gave way for the development of the new mesh method.  Familiarity for surgeons with the transobturator region increased as a result of the deployment of… Continue Reading

TVM complications found to be frequent and dangerous

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Over the past 20 years, the use of mesh for correction of sphincteric abnormalities has greatly increased.  High success rates and simpler surgical techniques have helped its overall appeal.  Recently, there has been mounting concern over potential complications with this new procedure.  4,000 reports of TVM complications were submitted to the FDA by 2010-average of… Continue Reading

High rate of POP recurrence associated with vaginal mesh

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It is estimated that 300,000 pelvic organ prolapse related surgeries are performed in the United States every year.  Pelvic organ prolapse is a global wide health issue for women.  High failure rates are seen with anterior surgical repair of cystocele or anterior wall prolapse.  These procedures may constrict and impair vaginal anatomy.  Some doctors recommend… Continue Reading

High rate of complications with TVM use, study shows

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The use of transvaginal mesh for both the repair of prolapsed pelvic organs and incontinence has led to numerous transvaginal mesh lawsuits because of the high failure rate experienced clinically, and vaginal mesh-related infections.  These issues have been recently traced by researchers, who currently believe that the lack of postoperative research done on these products… Continue Reading

2011- Study shows vaginal mesh cost-ineffective

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As nearly 1 in 10 of all women who experience pelvic organ prolapse, numerous efforts have been made to treat its symptoms.  The use of transvaginal mesh has grown substantially in its clinical popularity, leading to its being the preferred method for surgical treatment of pelvic organ prolapse.  However, it has been noted that a… Continue Reading

Many “issues surrounding” the use of TVM

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Vaginal mesh devices have recently been used to vaginal wall prolapse and incontinence in women, but unfortunately they have been proven to be problematic in a number of ways.  Legal issues have been arising as treatment involving the surgical use of vaginal mesh kits have led to complications related to both abnormal injury and inadequate… Continue Reading

Study Shows: Vaginal Mesh Also Unsafe for UI Surgery

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Urinary incontinence plagues people all over the world, leading to experiences of discomfort and stress.  Midurethral mesh slings are now the most popular method for surgically alleviating urinary incontinence.  These mesh slings are the very same synthetic meshes that are used in pelvic floor reconstruction following pelvic organ prolapse.  In recent years, the difference between… Continue Reading

2013 – Transvaginal mesh widely considered unsafe

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Because nearly one tenth of all women worldwide experience pelvic organ prolapse (POP) during their lives, many top medical professionals today strive to develop treatment more reliable than transvaginal mesh (TVM), a treatment option associated with a high rate of failure and complications of vaginal mesh. A current study titled, “Indications, Contraindications, and Complications of… Continue Reading