Posts Tagged ‘complications’

Vaginal Mesh Helpline Helping women Nationwide

Monday, March 26th, 2012

The Vaginal Mesh Helpline is seeing an alarming increase in women and family members calling for both medical and legal help. The reported complications range from mild to very severe and some even life threatening. “They are all very similar”

says Lisa Spitzer MSW who speaks to most of the callers personally “The mesh was usually implanted to help strengthen a weakened pelvic floor” Says Spitzer ” In a women the pelvic floor consists of the bladder, bowel and Uterus, The vaginal wall is an intricate system of muscle and ligaments that can weaken from age, child birth or hysterectomy. Sometimes it is just poor genetics. Many women went in for a hysterectomy and came out with a mesh”” Doctors were lead to believe the mesh was the miracle answer”” very often the mesh was used for very mild SUI”” Women began having complications and infections when the mesh began to fail” The symptoms of a failed mesh which are reported to us include severe razor blade pain or pain that feels like child birth, pain on one side of the body, lower back pain, Spot bleeding, inability to have sexual intercourse, Increased incontinence or problems voiding, Bowel related symptoms or abdominal pain, difficulty sitting and infections.” ” It is important women understand they are not alone”” It is reported over 300,000 women have been implanted with mesh devices”We asked what is the mesh made of ” The mesh is made of a synthetic propylene fiber, a stretchy synthetic material.””When it falls apart and erodes it is very painful” She continues ” Women are angry at their Doctors”” many women are going back to the Doctors that put the Mesh in with no help”” They are being told it is all in their mind, just get used to it, We can try to trim it, It cannot be removed, we do not have your records any longer, try physical therapy, It is your fault for coughing, It is because you smoke and cough, get a colonoscopy, it is a tumor, and everything imaginable other then it could be the mesh failing. In October 2008 the FDA issued a warning regarding the vaginal mesh implants to Healthcare practitioners.

If you or anyone you know has been hurt by any Vaginal Mesh, Call us at: 877 882 0095

For full article see: //world.einnews.com/pr_news/86730936/vaginal-mesh-helpline-helping-women-nationwide

Lawsuit Filed by a Texas Women Alleging Vaginal Harm Caused by Vaginal Mesh Product

Wednesday, August 3rd, 2011

A Texas woman has filed a lawsuit against American Medical Systems (AMS) over problems with vaginal mesh manufactured by the company, which allegedly caused her to suffer a number of serious injures and complications after pelvic organ prolapse surgery.

The complaint was filed last month in Los Angeles Superior Court by Laura Jones, of El Paso, Texas, against AMS and a number of other unnamed manufacturers

The victim, Mrs. Jones, had an AMS vaginal sling implanted in 2009 and subsequently experienced severe pain, urinary problems and had a number of additional surgeries remove the insidious mesh.

For related information see: //www.aboutlawsuits.com/ams-vaginal-mesh-lawsuit-sling-19271

If you or someone you know is facing problems similar to those described, contact us at: 888 422-2882

July 27/11 News: FDA: Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

Wednesday, August 3rd, 2011

Dear Healthcare Practitioner:
This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.
Nature of the Problem
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
Recommendations

Physicians should:

  • Obtain specialized training for each mesh placement technique, and be aware of its risks.
  • Be vigilant for potential adverse events from the mesh, especially erosion and infection.
  • Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
  • Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
  • Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
  • Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

If you or someone you know is facing problems similar to those described, contact us at: 888 422-2882

Transvaginal Placement of Surgical Mesh Products Give Rise to Severe Health Complicaitons

Wednesday, August 3rd, 2011

On October 20, 2008, The FDA issued a dear healthcare practitioner notice, concerning complications associated with transvaginal placement of surgical mesh for certain procedures. The notification indicated that the FDA had received over 1,000 reports from nine surgical mesh manufacturers

Essentially, these mesh devices act like a hammock and are surgically placed transvaginally (along and behind the vagina) to support the uterus, the bladder, and other pelvic organs. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia

Certain products include:

Manufacturer Product Name (Device) Number of MAUDE Events
American Medical Systems SPARC 65
Ethicon Gynemesh PS (K013718) a/k/a/ Prolift Pelvic Floor 123
Johnson & Johnson Tension-Free Vaginal Tape (K974098) Also Medscand Medical Lab (Sweden), Ethicon, Inc., Ethicon Sarl (Switzerland), 495
Mentor ObTape (K031767) 236

If you or someone you know is facing problems similar to those described, contact us at: 888 422-2882

Transvaginal Placement of Surgical Mesh Products Give Rise to Severe Health Complicaitons

Tuesday, August 2nd, 2011

On October 20, 2008, The FDA issued a dear healthcare practitioner notice, concerning complications associated with transvaginal placement of surgical mesh for certain procedures. The notification indicated that the FDA had received over 1,000 reports from nine surgical mesh manufacturers

Essentially, these mesh devices act like a hammock and are surgically placed transvaginally (along and behind the vagina) to support the uterus, the bladder, and other pelvic organs. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia

Certain products include:

Manufacturer Product Name (Device) Number of MAUDE Events
American Medical Systems SPARC 65
Ethicon Gynemesh PS (K013718) a/k/a/ Prolift Pelvic Floor 123
Johnson & Johnson Tension-Free Vaginal Tape (K974098) Also Medscand Medical Lab (Sweden), Ethicon, Inc., Ethicon Sarl (Switzerland), 495
Mentor ObTape (K031767) 236

If you or someone you know is facing problems similar to those described, contact us at: 888 422-2882

July 27/11 News: FDA: Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

Tuesday, August 2nd, 2011

Dear Healthcare Practitioner:
This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.
Nature of the Problem
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
Recommendations

Physicians should:

  • Obtain specialized training for each mesh placement technique, and be aware of its risks.
  • Be vigilant for potential adverse events from the mesh, especially erosion and infection.
  • Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
  • Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
  • Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
  • Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

If you or someone you know is facing problems similar to those described, contact us at: 888 422-2882

Lawsuit Filed by a Texas Women Alleging Vaginal Harm Caused by Vaginal Mesh Product

Tuesday, August 2nd, 2011

A Texas woman has filed a lawsuit against American Medical Systems (AMS) over problems with vaginal mesh manufactured by the company, which allegedly caused her to suffer a number of serious injures and complications after pelvic organ prolapse surgery.

The complaint was filed last month in Los Angeles Superior Court by Laura Jones, of El Paso, Texas, against AMS and a number of other unnamed manufacturers

The victim, Mrs. Jones, had an AMS vaginal sling implanted in 2009 and subsequently experienced severe pain, urinary problems and had a number of additional surgeries remove the insidious mesh.

For related information see: //www.aboutlawsuits.com/ams-vaginal-mesh-lawsuit-sling-19271

If you or someone you know is facing problems similar to those described, contact us at: 888 422-2882

Lawsuit Filed by a Texas Women Alleging Vaginal Harm Caused by Vaginal Mesh Product

Friday, July 29th, 2011

A Texas woman has filed a lawsuit against American Medical Systems (AMS) over problems with vaginal mesh manufactured by the company, which allegedly caused her to suffer a number of serious injures and complications after pelvic organ prolapse surgery.

The complaint was filed last month in Los Angeles Superior Court by Laura Jones, of El Paso, Texas, against AMS and a number of other unnamed manufacturers

The victim, Mrs. Jones, had an AMS vaginal sling implanted in 2009 and subsequently experienced severe pain, urinary problems and had a number of additional surgeries remove the insidious mesh.

For related information see: //www.aboutlawsuits.com/ams-vaginal-mesh-lawsuit-sling-19271

If you or someone you know is facing problems similar to those described, contact us at: 888 422-2882

July 27/11 News: FDA: Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

Friday, July 29th, 2011

Dear Healthcare Practitioner:
This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.
Nature of the Problem
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
Recommendations

Physicians should:

  • Obtain specialized training for each mesh placement technique, and be aware of its risks.
  • Be vigilant for potential adverse events from the mesh, especially erosion and infection.
  • Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
  • Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
  • Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
  • Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

If you or someone you know is facing problems similar to those described, contact us at: 888 422-2882

Transvaginal Placement of Surgical Mesh Products Give Rise to Severe Health Complicaitons

Friday, July 29th, 2011

On October 20, 2008, The FDA issued a dear healthcare practitioner notice, concerning complications associated with transvaginal placement of surgical mesh for certain procedures. The notification indicated that the FDA had received over 1,000 reports from nine surgical mesh manufacturers

Essentially, these mesh devices act like a hammock and are surgically placed transvaginally (along and behind the vagina) to support the uterus, the bladder, and other pelvic organs. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia

Certain products include:

Manufacturer Product Name (Device)   Number of MAUDE Events
American Medical Systems SPARC   65
Ethicon Gynemesh PS (K013718) a/k/a/ Prolift Pelvic Floor   123
Johnson & Johnson Tension-Free Vaginal Tape (K974098) Also Medscand Medical Lab (Sweden), Ethicon, Inc., Ethicon Sarl (Switzerland),   495
Mentor ObTape (K031767)   236

If you or someone you know is facing problems similar to those described, contact us at: 888 422-2882

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