The end of July many lawyers will be closing their doors to accepting mesh cases from states with one and two year vaginal mesh implants. N.Y is  a “safe state” with a 3 year staute of limitations but, that does not mean you should wait. We can still help women in the one and 2 year statute states but, do not delay. New York vaginal mesh lawyers are helping victims of the mesh in: New York State including: Albany, Buffalo, Binghamton, Dobbs Ferry, Floral Park, East Rochester, Great Neck, Hempstead, Harrison,  Kingston, Larchmont, Levittown,Manhasset, Oswego, Pelham, Port Chester Rochester, Saratoga Springs, Syracuse,  Utica, Babylon, White Plains, Woodbury, Yonkers, Queens, Brooklyn, Manhattan,  Mount Kisco,  East Hampton, Hampton,  Kingston, Yonkers and all of New York and NYC.

What are the Transvaginal Mesh Complications ?

• Erosion of vaginal tissue can result from a vaginal mesh
• Hardening of the vaginal mesh
• Infection is a serious mesh-patch complication
• Pain and discomfort
• Perforations of the bowel, bladder or blood vessels
• Recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
• Urinary problems and more severe incontinence
• Painful sexual intercourse
• Potential injury to the partner
• Feeling the mesh or pieces of substance in the vaginal canal
• Vaginal mesh erosion
• Increased incontinence
• Lower back pain
• Abdominal pain
• Gastrointesitnal discomfort
• Bladder and or bowel incontinence
• Difficulty voiding and the need for self catherizations
• Vaginal scarring

You must see a urogynecologist and speak to a vaginal mesh lawyer right away.

Vaginal Vaginal Mesh Helpline is reaching out to women in the greater NYC area to help them locate a vaginal mesh lawyer. There are over 300,000 women with a vaginal mesh and our job is to find every single one and make sure they file their mesh lawsuit and find a doctor. It is not a question of money it is a question of protecting other women and standing up for justice.

The mesh isd a Prolene synthetic substance palce in the most intimate part of your body. These mesh were moved thr without sufficient testing and so many women are suffering thru-out the greater NYC areas of Westchester and Rockland counties. The helpline is here ready to help you.

Rockland County help is here for women with a mesh. Westechester county women we are here for you.

Symptoms of a Failed Mesh

• Relentless pain
• Lower back pain
• Pain on one side
• digestive disorders
• Infections
• Mesh erosion
• Bladder, bowel perforation and pain
• incontinence
• troubke voiding
• bleeding

UPDATE 01/04/2012: FDA Update on Surgical Mesh

    Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.

The FDA continues to assess the safety and effectiveness of urogynecologic surgical mesh devices, through:

    Review and analysis of published literature, Medical Device Reports (adverse event reports) submitted to the agency, and post-approval study reports.
    Epidemiological research on safety and effectiveness of surgical mesh, as a part of our effort to better understand possible adverse events associated with surgical mesh for SUI and POP.
    Collaborations with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, as well as the occurrence of and signs and symptoms associated with specific adverse events.
    Collecting and reviewing all available information about currently marketed urogynecologic surgical mesh devices.
    Mandating postmarket surveillance studies (“522 studies”) by manufacturers of urogynecologic surgical mesh devices. On January 03, 2012, the FDA issued:
    88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for POP; and
    11 postmarket study orders to seven manufacturers of single-incision mini-slings for SUI.

The manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices for SUI. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices. For information on the status of the 522 Postmarket Surveillance Studies and the FDA’s authority to order 522 studies, visit the 522 website.

The FDA will provide additional information to the public as it becomes available.

The Vaginal Mesh Helpline hears from women on a daily basis regarding their complications. Based on what we hear the FDA is moving to slow. There are obvious complication with these surgical mesh implants and they are destroying the lives of 1000's of women nationwide.  We encourage wome to seek legal counsel regarding a modified district liltgation for their vaginal mesh and bladder sling implants immediately.

What Reclassification of Vaginal Mesh Products Would Mean
 

Could vaginal mesh products represent “the next medical device controversy”? That was the suggestion of an article over on Business Week. The devices, which have recently been implicated in roughly 600 lawsuits, have been getting a lot of attention lately (along with metal-on-metal implants). In July, FDA warned that there had been a fivefold increase in the number of women suffering complications caused by the devices. The number of lawsuits began to build after FDA made that announcement. (Pensacola, FL) in the Business Week piece.
 
A good analysis of the issue can be found on twitter, of all places. Chris Thierfelder a self-described med-tech innovator based in Santa Barbara, CA explains, in a series of messages, his views on FDA's proposal to reclassify transvaginal mesh products as Class III devices—a move the agency says would better reflect their risk to patients. Thierfelder, however, thinks the move would be severe. Class III devices are usually used for life-or-death scenarios, he points out. Examples of such devices include heart valves and pacemakers.

Vaginal mesh currently fall under the Class II designation, which is designed to represent products with a moderate risk. Reclassifying them would bar the products from eligibility for the 510(k) approval process. In addition, achieving Class III approval requires controlled, clinical data to be gathered before the product is available for open market use. That can takes years to acquire.

Thierfelder looks at the base numbers: For vaginal mesh, there were roughly 1500 failures per 75,000 devices over three years. The majority of incidents could be corrected while the patient was under sedation.

An article on CommonHealth explains that many pelvic surgeons don’t agree with FDA’s proposal to reclassify the vaginal mesh as a Class III device. “We have some significant disagreement with the conclusions reached [by FDA] and concerns regarding the message that it is sending to our patients, the healthcare community, and unfortunately to the legal community as well,” states a letter that was signed by more than 600 pelvic surgeons.

Mesh has the advantage of being inexpensive and generally effective. Thierfelder calls it “a [relatively] low-risk, low-cost solution to a quality-of-life problem. On the other hand, Class 3 devices are usually used for life-or-death situations.  “Classifying mesh as class 3 would wipe out a very effective method for treating a big problem. What fills the void?” he writes. He compares the use of the mesh with traditional surgery, which has a "debatably higher rate of more severe complications."

In the end, Thierfelder sums up his position like this: “In the end, re-classification of devices is very hazardous, and should be taken in the broader context…Not that business is greater than safety, but be mindful," he concludes.

That's a convincing argument. And one of the most thorough ones on the issue I've seen, well, anywhere. In case you use twitter, I recommend following Thierfelder at @Hamlet.

—Brian Buntz

Update:

Thierfelder has left a comment to this post (see below), explaining there were some other points that weren't mentioned above.

In essence, he explains that consumers who have suffered complications from the devices have the right to be upset. He adds that some earlier versions of the devices were "not so good"; current versions are much safer. In addition, physicians would have likely benefitted from more in-service training, which may have led to a decrease in complications. More data on the safety of the devices also would have been helpful: "[Only in the last couple of years have we started figuring out who's a good candidate. There's new data, no thanks to industry," he adds.

In the end, he says that industry can self-correct but that is is unlikely for it do so quickly enough.

Vaginal Mesh Helpline is taking calls from women nationwide daily regarding their vaginal mesh complications

Prolene mesh and your prolapse surgery – erosions, sex, and the latest data. The transvaginal mesh is made of a prolene substance which is creating problems in woman with the various transvaginal mesh patch implants. The following information on the prolene mesh substance is of interest and being passed along for our readers. In doing so we hope to offer informations,support and help to women who have been suffering form these vaginal mesh products. Many of our callers and followers do not really understand what these mesh products are. They merely followed the advise of their physicians to relieve discomfort and improve theor quality of life. Hope has  turned to pain and women worldwide have stories to tell about their transvaginal Mesh.

The following is by Lauri Romanzi on the prolene mesh

Prolene Mesh and Pelvic Organ Prolapse
Cystocele, rectocele, erosions, sex, mesh shrinkage, folding and thickening,transvaginal mesh

Prolene mesh is the product name for a permanent plastic mesh with many implantation applications in reconstructive surgery. Prolene mesh is used to fix large and small abdominal hernias, inguinal hernias, hernias of the diaphragm; it’s used to resuspend kidneys (nephropexy) rectums (rectopexy), uteri (aka uterus’ plural) (sacrohysteropexy), prolapsed vaginas after hysterectomy (sacrocolpopexy), chin augmentations (mentoplasty), chest wall repair in certain thoracic surgeries, (abdominal hernias (inguinal, umbilcal, ventral) and both male and female urethral sling operations for stress urinary incontinence, to name a few.

Over the last 8-10 years, the use of prolene mesh for vaginal prolapse surgery has expanded to include cystocele and rectoceele repair, In an effort to standardize application and, arguably, make it easier for gynecology, urogynecology and urology surgeons to use the mesh, and, definitely, to market the new pelvic organ prolapse mesh kits effectively, Prolene mesh companies have tweaked mesh pore size (degree of laciness), thickness, and density; they’ve mixed it with other graft materials, impregnated it with various materials, each in an effort to reduce horrific complications and claim clinical superiority. The industry cannot advertise or market superiority without data, so they sponsor scientific clinical trials hoping for favorable data that will legally permit them to claim product  superiority in marketing activities, via studies paid for in part or in full by the companies manfacturing the mesh, often but not always recruiting surgeons who work as paid advisors and consultants, much the same way pharmaceutical companies use paid advisors to participate in clinical drug trials. I know, I’ve been, at various points in my career, one of those advisor/consultants. It is a very fine ethical tightrope clinicians walk when participating at that level. The perks are large. The rewards many. It’s an elite group of clinical industry insiders that trumpet the merits of these meshes. Those surgeons publishing outside of the advisory board arena compete for journal space along side industry funded trials.

A few times a year, I and a few colleagues comb the literature for the Journal of Sexual Medicine, fashioning reviews of research with a sexual function implication. This month, I found three that “turn me on” – 2 of which focus on Prolene mesh for vaginal implantation in pelvic organ prolapse surgery for cystoceles (dropped bladders) and rectoceles (back wall vaginal hernias).

Here are the two trials on 2 different Prolene mesh kits: AMS Perigee and Gynecare Prolift.

The first study, using Prolift, found that young sexually active women were more likely to suffer vaginal erosion of mesh, literally mesh showing where the vaginal skin over it has eroded away. A bit of a problem, if your young, like sex, have prolapse, and use Prolene mesh, at least with this particular kit, to have it fixed. Prolene mesh in the vagina creates a mechanical risk of sexual dysfunction; your sex life could, quite literally, hit the skids. Forget carpet burns, we’re talking penis-meets-sand paper. Woops.

The second study, using a different brand of Prolene mesh vaginal prolapse kit for dropped bladder (cystocele) repair called Perigee, claims a close-to-zero mesh erosion rate, each erosion “minimal and easily remedied” with a bit of tinkering in the office. The investigators report some interesting ongoing changes in the sonographic appearance of the mesh once implanted in the vagina. In this study, Prolene mesh demonstrated folding in a few, and continued to shrink or shorten and thicken more and more at each of three sonograms done in the first year after implantation. Makes you wonder how it’s behaving after, say, 5  or 10 years.

I’ve said before and I’ll say again here, Prolene mesh ribbons for uterine suspension, vaginal cuff suspension after hysterectomy and female urethral sling operations for urinary incontinence have been around a long time and really do seem, in my experience and in my opinion, to work very well with low rates of minimally bothersome, easy to fix complications. BUT I’ve seen nightmares with Prolene mesh kits used for cystocele and rectocele repair – full recurrence of the prolapse, sometimes worse that before surgery, along with horrific, painful, bleeding mesh  vaginal or bladder erosions, kinking of ureters (the tubes that drain urine from your kidney to your bladder) glued to the mesh requiring ureteral re-implantation into a diffierent part of the bladder (this is big surgery, not a quickie), in addition to mesh bundles eroding into the vagina creating bleeding vaginal wounds that make sex impossible. Explanting (removing it in full) Prolene mesh from the anterior and posterior walls of the vagina is no easy task.

The Vaginal mesh helpline listens to women daily with horror stories of the complications of the mesh. Tell us your stories.We want to hear from you iin: Auburn AL; Birmingham AL; Dothan AL; Gadsden AL; Huntsville AL; Mobile AL; Montgomery AL; Muscle Shoals AL; Tuscaloosa AL; Anchorage AK; Fairbanks AK; Juneau AK; Flagstaff AZ; Sedona AZ; Mohave County AZ; Phoenix AZ; Prescott AZ; Show Low AZ; Sierra Vista AZ; Tucson AZ; Yuma AZ; Fayetteville AR; Fort Smith AR; Jonesboro AR; Little Rock AR; Bakersfield CA; Chico CA; Fresno CA; Humboldt County CA; Inland Empire CA; Long Beach CA; Los Angeles CA; Mendocino (new) CA; Merced CA; Modesto CA; Monterey CA; O.C. 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We have attorneys in: Alabama Al Alaska Arizona Az Scottsdale Arkansas California Ca Colorado Co Connecticut Conn Delaware De D.C. Florida Fl Georgia Ga Hawaii Idaho Illinois Ill Indiana Iowa Kansas Kentucky Louisiana La Maine Maryland Massachusetts Mass Michigan Mi Minnesota Minn Mississippi Ms Missouri Mo Montana Nebraska Nevada Nv New Hampshire New Jersey N.J. New Mexico. N.M New York N.Y Brooklyn Queens Staten Island Long Island Westchester North Carolina North Dakota N.C Ohio Oh Oklahoma Ok Oregon Pennsylvania Pa Rhode Island RI South Carolina S.C South Dakota S.D Tennessee Tenn Texas TX Utah Ut Vermont Virginia Washington Wa West Virginia Wisconsin Wyoming.