Physician, Surgeon & Lawyer
Missouri & Nationwide Assistance
Defective transvaginal surgical mesh & sling products
Use of transvaginally implanted surgical mesh / sling products shown to have serious side effect
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Questionnaire
TREATMENT OF PELVIC ORGAN PROLAPSE WITH SURGICAL MESH
Pelvic organ prolapse (POP) occurs when a pelvic organ (like your bladder) slips out of place and pushes against the wall of the vagina. The most common cause of POP is the weakening or stretching of the pelvic muscles due to child birth or surgery. Women who have POP can suffer from pelvic discomfort, interference with sexual, urinary and defecatory functions, as well as other daily activities. This can seriously impact their quality of life.
Transvaginal mesh was introduced to help correct this problem. Although surgical mesh has been used to repair abdominal hernias since the 1950s, the first surgical mesh product specifically designed to treat POP was approved by the FDA in 2002. Surgeons began using surgical mesh to augment transvaginal POP repairs. The mesh is generally configured to match the anatomical defect they are designed to correct. The mesh can be attached to the anterior or posterior vaginal wall or to the top of the vagina with sutures. Most surgical mesh devices used for transvaginal procedures are composed of a non-absorbable synthetic material.
After its introduction in 2002, these products were incorporated into repair "kits" that also included tools to aid in the delivery and insertion of the mesh. Some of these products were sent to the market using the FDA's 510(k) process, which allows a product to bypass the usual rigorous safety testing standards if the product is shown to be "substantially equivalent" to something that is already on the market.
TVM LINKED TO SERIOUS COMPLICATIONS & DEATH
Since 2005, the FDA has received almost 4,000 reports of malfunction, injury or death associated with transvaginal surgical mesh products. Over half of those reports were received between January 1, 2008 and December 31, 2010. The complaints have ranged from vaginal mesh erosion (exposure, extrusion or protrusion); pain (including pain during sexual intercourse), urinary problems, infection, bleeding and organ perforation. There have also been reports of neuro-muscular problems, recurrent prolapse, and vaginal scarring/shrinking, as well as emotional problems that arise from these complications. Many of these conditions required medical intervention, including surgical treatment and hospitalization. There have also been reports of death due to bowel perforations and hemorrhage.
These complications are not generally present in patients who have undergone POP repair without mesh products. Furthermore, there have been no indications that transvaginally placed mesh improves the clinical outcome of a POP repair versus traditional non-mesh repair.
In fact the opposite has been shown. Complications involving transvaginally placed mesh are NOT RARE, and can be life threatening.
HOW WE CAN HELP
At the law office of Brad Bradshaw M.D. J.D., we have extensive background, experience and results in medical legal cases. Why should you choose our firm to represent you? We work on cases throughout the United States, with lawyers in various jurisdictions, and seek to obtain what we believe are the best locations to pursue cases for both settlement and litigation. We work with other law firms to try and maximize our clients' recoveries. Additionally, we have successfully litigated and settled other cases involving both dangerous drugs and defective medical devices.
If you have suffered from complications due to defective transvaginal mesh or other similar products, contact our office for a free consultation. Please call us toll free at 888-775-0000. To expedite review of your potential case, you can complete our questionnaire by clicking here. Please wait at least 15 minutes after submitting the questionnaire before contacting our office. Be sure and let us know if you completed the questionnaire.
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RESOURCES
FDA Safety Communication
FDA Safety Update
ABC News Story
MedPage News Story
FDA Public Health Notice