Transvaginal mesh is an implantable synthetic device that is used for the treatment of pelvic organ prolapse (POP). Multiple medical manufacturing companies have marketed this medical device including Johnson & Johnson, American Medical Systems, Bard and Boston Scientific. However, since the release of the use of the product many women are experiencing complications that include erosion of the vaginal mesh, vaginal scarring, infection, urinary problems, painful sexual intercourse, pain, bleeding and additional corrective surgeries. In some of these situations the mesh can be surgically removed but sometimes removal is not possible.
The approval process that the mesh was submitted to before being marketed was minimal and Consumer Reports has spoken out against the FDA approval process. The medical device may have been surgically inserted without any formal testing. As many as 10% of recipients may have experienced some form of complications. More than 75,000 women receive a transvaginal mesh device every year to treat pelvic organ prolapse, stress incontinence, or similar pelvic issues.
More than 650 patients have filed vaginal mesh lawsuits. Read more about vaginal mesh complications at LegalView.
Transvaginal mesh is a synthetic mesh that is implanted through the vagina for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Several vaginal mesh products have been subjected to multiple lawsuits following formal FDA reports warning consumers of the danger of the medical device. The mesh received approval from the United States Food and Drug Administration (FDA) through a series of loopholes that allow devices to marketed if they are similar to other products already on the market.
Women have listed mesh shrinkage, bleeding, infection, painful urination, painful sexual intercourse, and reoccurrence of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) following treatment with the synthetic transvaginal mesh.
The most common reported complication is mesh erosion which is when the device erodes into surrounding tissues.
By the age of 80, almost 10% of women will undergo surgery for POP.As many as 10% of those women will experience complications.
- Cystocele
- Enterocele
- Rectocele
- Urethrocele
- Uterine prolapse
- Vaginal vault
Cytocele is when the bladder protrudes into the vagina. This condition may cause discomfort and problems with emptying the bladder.
Enterocele is when the small intestine protrudes into the vagina.
Rectocele is when there is a tear in the rectovaginal septum and rectal tissues bulge from the vagina. Symptoms may cause pressure in the vagina, the feeling that the rectum has not been emptied after a bowel movement, difficulty passing stool, discomfort or pain during evacuation or intercourse, and/or constipation.
Urethrocele is when the urethra prolapses through the vagina. Symptoms may include stress incontinence, increased urinary frequency, difficulty emptying the bladder and/or pain during sexual intercourse.
Uterine prolapse is a prolapse of the uterus. Uterine prolapse happens when the ligaments holding the uterus become weak and the uterus cannot stay in its normal position.
Vaginal vault is an expanded region of the vaginal canal at the end of the vagina. This may occur following a hysterectomy.
Recent FDA reports suggest that some treatment options for female genital prolapse may have harmed the recipients. Many women who have received transvaginal surgical mesh have experience several complications including: pain, infection, bleeding, and most commonly, mesh erosion.
Pelvic organ prolapse is a condition where the muscles and ligaments supporting a woman’s pelvic organs weakenout of place. A vaginal prolapse can happen after menopause, childbirth or a hysterectomy.The common symptoms include: loss of bladder control, difficulty emptying your bladder, increased feeling of the need to urinate, pelvic or vaginal heaviness, bulging, fullness and/or pain, recurring bladder infections, excessive vaginal discharge, and pain during sex.
POP can get worse over time. One way to fix it is by surgery where vaginal mesh is inserted to support the organs. Only cases that cause severe discomfort or pain need to be treated with surgery. If you have mild symptoms there are other options available to help with POP such as kegel exercises and vaginal pessaries.
Two Canadian women who received vaginal mesh surgeries in 2006 recently filed a class action lawsuit in association with the complications they suffered after they were implanted with the vaginal mesh devices. Last June the United States’ Food and Drug Administration released a statement saying that vaginal mesh complications after surgery were not uncommon. They also stated that vaginal mesh was not superior to other treatment options for vaginal prolapse and stress urinary incontinence.
They two women suffered from intense pain following their surgeries that implanted the vaginal mesh. One of the women actually had to quit her job because she could not stand for long periods of time due to the excruciating pain. Complications are experienced in as many as 10% of women who have transvaginal mesh. Side effects include mesh erosion and or mesh shrinkage. Both of these side effects can cause extreme pain, discomfort, painful intercourse, and even additional surgeries.
February 5, 2013 was set as the first transvaginal mesh lawsuit that will go to trial against C.R. Bard Inc. This is the first date set for over 600 transvaginal mesh lawsuits against the manufacturers. The lawsuit claims the device caused organ damage.
Currently there are about 1,000 liability lawsuits against four of the medical device makers that have been filed over transvaginal mesh devices. Woman claim that the device caused them to experience side effects such as pain during intercourse and loss of bladder control.
The United States’ Food and Drug Administration ruled in June of 2011 that the vaginal mesh complications were not uncommon. They also decided that the vaginal mesh was not better than the more traditional treatments for pelvic organ prolapse and stress urinary incontinence. According to many women vaginal mesh surgery has done little to solve their problems of pelvic organ prolapse or stress urinary incontinence. Women have been left with the symptoms of the original condition as well as new symptoms such as erosion and infections.
A common treatment option for POP (pelvic organ prolapse) or SUI (stress urinary incontinence) is tranvaginal mesh surgery. POP and SUI can be caused by weakened pelvic muscles due to multiple childbirths, hysterectomy surgeries, or even obesity. The treatment is meant to relieve the patient from symptoms, yet the mesh is now causing complications in up to 10% or recipients.
Vaginal mesh was introduced as a surgical treatment option for POP and SUI. Many women who have undergone vaginal mesh surgeries are experiencing mesh erosion and or mesh shrinkage as a side effect. Mesh erosion is when the vaginal mesh moves from the spot where it was implanted, and mesh shrinkage is a change in size of the mesh device. Both of these side effects can cause extreme pain, discomfort, painful intercourse, and even additional surgeries.
These two not uncommon symptoms have pushed patients to assert their rights in court against the makers of the mesh devices. The manufacturers knowingly marketed these medical devices without proper testing. Numerous lawsuits have been filed by different women across the U.S.
Read more about vaginal mesh injuries, mesh erosion, and mesh shrinkage at LegalView.
Several manufacturers that are common household names marketed transvaginal mesh implants without having tested them. Among these manufacturers are medical device giants such as Johnson & Johnson and Boston Scientific. The products were allowed to be marketed because they were similar to another product that had already been tested. However, recent data shows that as many as 10% of women who have received these implants are experiencing complications.
The FDA’s approval process has been placed under scrutiny after several devices have been recalled. The current protocol allows companies to introduce products without testing if they are similar to devices already for sale. This is not the first time that FDA has faced criticism. In 2010 J&J was once again in the limelight after withdrawing hip prosthetics that experienced a higher-than-expected failure rate.
The number of deaths, injuries or malfunctions tied to vaginal mesh for prolapsed organs has increased since the release of the product. The FDA has looked at reclassifying the mesh as “high-risk” due to this increase in numbers. In addition to J&J other manufacturers such as Murray Hill and C.R. Bard Inc. (BCR) have been urged to look into the damage and complications related to the products.
Patients have been taking matters into their own hands as well. Hundreds of lawsuits have been filed against all of the manufacturers of the mesh. Read more about vaginal mesh complications at LegalView.
Pelvic organ prolapse, otherwise known as POP, is when a woman’s pelvic organs protrude through the vaginal opening due to multiple childbirths or a hysterectomy. The organs that can prolapse are the bladder, urethra, uterus, vagina, small bowel, and/or the rectum slip can also slip out of place. Thousands of women have used transvaginal mesh as a form of treatment for POP but recent findings show that the benefits of using the mesh do not outweigh the costs. As many as 10% of women have experienced complications as a result of the mesh.
Listed below are alternative treatment options for pelvic organ prolapse.
- Prescribed medications. Medical professionals may advise patients to take estrogen replacement therapy (ERT) if they believed the pelvic organ prolapse may be a cause of low estrogen.
- Physical therapy. Medical professionals may recommend physical therapy in patients to strengthen the muscles of the vaginal wall. The stronger muscles may reverse the prolapse. These can be done through a series of exercises or by electrical stimulation.
- Pessaries. Pessaries are a removable plastic, rubber or silicone device that can be used to help treated pelvic organ prolapse. The pessary can be placed temporarily or permanently and is used to support the pelvic organs
Please consult your doctor before choosing a treatment option so that the correct option may be selected for your symptoms.
Boston Scientific, a medical device maker faces up to 300 lawsuits from transvaginal mesh cases. Similar stories are also be reported with their rival manufacturers as well. The transvaginal mesh is used to help with pelvic organ prolapse or incontinence but seems to be hurting its recipients more then helping them.
The lawsuits could cause a multimillion-dollar problem for the manufacturing companies. The lawsuits have followed a FDA reversal last year that stated that multiple women have been experiencing similar issues after having the mesh implanted. The number of women experiencing complications with the mesh inserts can be as high as 10 percent.
Boston Scientific has not made any comments in conjunction with the litigation but has stated that the mesh is still a treatment option for patients and that they will continue to work with the FDA to ensure that appropriate information about the mesh products is provided to patients and their doctors.
Some patients are questioning whether or not they were informed of the potential risks. Patients claim that the complications were underreported.
These lawsuits can have a huge financial impact on the manufacturers and it one way of drawing attention to risks of the transvaginal mesh.
