Bladder Sling & Vaginal Mesh

If you or someone you know has been injured by a defective mesh or a bladder sling you should find the best personal injury attorney you can find. RepresentYou.com may be able to help you find a lawyer who has experience in dealing with bladder slings and vaginal mesh.  If you or someone you know have been injured by a transvaginal mesh patch call RepresentYou.com for a free case consultation to see if we can help you find a lawyer who is experienced, insured and has no disciplinary action. RepresentYou.com product liability and personal injury lawyers can take cases on a contingency fee basis. Which means your lawyer can pay all the costs and a fee charged for a lawyer’s services only if the lawsuit is successful or is favorably settled out of court. Contingent fees are usually calculated as a percentage of the client’s net recovery. No Win, No Fee.

Bladder Sling & Vaginal Mesh Problems

The bladder sling and vaginal mesh products have been common in surgery to repair weekend or damaged tissue, this implanted synthetic mesh has sharp edges that are in many cases piercing the surrounding tissue as a result of this the mesh can puncture the bladder,  bowel, uterus and other internal organs. The surgical mesh is also known to move while in someone’s body, this can create life long and serious damage.

Brand Names of Bladder Sling and Vaginal Mesh

Bladder Sling & Vaginal Mesh Lawsuits

Once the mesh is implanted it is very difficult to remove. Even after multiple surgeries doctors are sometimes unable to remove all of the mesh which by that point has become infused to the surrounding tissue, causing life-long problems. In some cases the petroleum based synthetic material has been know to become a hive for bacteria which can further complicate any problems you may have the a sling or mesh implant. In some cases these injuries can take years to develop after the initial surgery.

Sling and Mesh Side Effects and Complications

Bladder Sling & Vaginal Mesh FDA Alert

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

Date Issued: July 13, 2011

Audience:

  • Health care providers who implant surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence
  • Health care providers involved in the care of patients with surgical mesh implanted to repair pelvic organ prolapse and/or stress urinary incontinence
  • Patients who are considering or have received a surgical mesh implant to repair pelvic organ prolapse and/or stress urinary incontinence

Medical Specialties: gynecology, urogynecology, urology, general surgery, internal medicine, family practice, emergency medicine

Device:
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.

Background:
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.

Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.

Purpose:
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.

Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.

The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.

For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.

Summary of Problem and Scope:
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.

From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.

In particular, the literature review revealed that:

  • Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
  • Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
  • There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
  • While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.

The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.

Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.

More Information: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

Bladder Sling & Vaginal Mesh Recall

No the sling and mesh has not been recalled however, the FDA has issued an alert below is the FDA’s activities regarding urogynecologic mesh products.

FDA Activities:
The FDA is working in several areas to assess and improve the safety and effectiveness of urogynecologic mesh products. The FDA will:

  • Convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, on September 8-9, 2011.The panel will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and SUI.
  • Explore regulatory solutions to answer questions about the safety and effectiveness of urogynecologic mesh products that are now being marketed and those that will be reviewed for marketing in the future.
  • Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing any and all data as it becomes available.

More Information: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

Biological Mesh

If you are looking for safe alternatives to mesh or sling some doctors are using a biological mesh, quoted below is some information about biological mesh from the The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.

The use of biological meshes seems to be an innovation that influences all surgical fields. The existing evidence indicates that biological meshes cannot only be applied on the area of hernia repair, but also on cases of abdominal reconstruction and pelvic organ prolapse treatment, especially in the presence of contaminated or potentially contaminated surgical fields. Low risks of graft rejection, complications, and infection seem to be the main advantages of biological meshes in comparison with the synthetic nonabsorbable ones. Nevertheless, the elevated costs suggest that biological mesh implantation should be evaluated in correlation to the needs of each clinical case.

More Information: http://www.ncbi.nlm.nih.gov/pubmed/21140701

Bladder Sling & Vaginal Mesh Lawyers

Like many medical devices, the surgical mesh patch is supposed to help people, but there is a chance that it may just be harming them. If you are one of these people who have been affected by a defective surgical mesh patch, you need to find representation for a mesh lawsuit. RepresentYou.com has access to some of the best surgical mesh attorneys and we may be able to get you in contact with one to help you receive the compensation you may be entitled to. So don’t hesitate and call RepresentYou.com now. At representYou.com we can also provide you with  hernia mesh patch lawyers, surgical mesh patch attorneys, transvaginal mesh patch lawyers and a verity of different recalled medical device lawyers.


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