What is Pelvic Organ Prolapse?
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs (bladder, the uterus, the rectum, the top of the vagina and the bowel) in place become weak or stretched. The organs can then bulge or prolapse into the vagina and sometimes prolapse past the vaginal opening. More than one organ can prolapse at a time and the prolapse is commonly caused by childbirth, a hysterectomy or after menopause. Thirty to fifty percent of women may experience POP at some point in their lifetime. POP can be uncomfortable and/or painful but it isn’t usually a big health problem. In some women, it does not progress and it can get better with time.
Some common symptoms of pelvic organ prolapse can include pressure from pelvic organs pressing against the vaginal wall, a feeling of fullness in the lower belly, the feeling that something is falling out of the vagina, pain in the lower back, the need to urinate frequently and incontinence.
Vaginal Mesh Brands
On July 13, 2011 the FDA issued a second warning for health care providers and patients who implant surgical mesh to repair pelvic organ prolapse (POP). The first warning came in October of 2008 when the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina.
The FDA warned that their were serious health concerns associated with the surgical implantation of transvaginal mesh. The FDA also stated that the serious complications associated with surgical mesh are not rare and that it has not been proven that POP repair with mesh is more effective than other forms of repair of POP. The FDA is continuing to look into the side effects and complications of using surgical mesh. The most common complication that women exhibit it erosion of mesh through the vagina. Mesh erosion can require multiple surgeries to repair and can be extremely painful for some women. In some cases, even surgeries cannot resolve complications.
The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh. Here a are list of brands of vaginal mesh that the FDA is looking into:
• Advantage™ Sling System
• Lynx™ Suprapubic Mid-Urethral Sling System
• Obtryx® Curved Single,
• Obtryx® Mesh Sling,
• Prefyx Mid U™ Mesh Sling System,
• Prefyx PPS™ System
Transvaginal mesh is a medical device that surgically implanted to repair damaged tissue that may result after childbirth or menopause. It can be made from a porous absorbable or non-absorbable synthetic material or absorbable biologic material. The mesh is surgically implanted to reinforce the weakened vaginal wall to repair POP.
Preventing Pelvic Organ Prolapse
Pelvic organ prolapse is a common condition in older women. It is most often a result from childbirth, labor and/or menopause. Although one may not be able to prevent the damage caused during childbirth, there are ways to slow the progression of the prolapse.
Maintain a healthy weight. Extra pounds may increase the risk of prolapse.
Correcting constipation. Constipation can weaken and damage the tissue and muscles in the pelvis.
Avoiding heavy lifting and jumping.
Strengthening pelvic muscles. Do Kegel exercises every day.
Quit smoking. Having a chronic cough can cause or speed pelvic organ prolapse.
Taking estrogen can help preserve and strengthen the tissues of the pelvis. (Talk to your doctor about this one!)
Type of childbirth-in some cases doctors may be able to reduce pelvic floor injuries by minimizing forceps deliveries and by selectively recommending elective cesarean delivery.
Questions to Ask Your Doctor About Vaginal Mesh Surgery
Before going through any surgery it is important to ask your doctor important questions that are associated with the risk of that surgery. Vaginal mesh is no exception. Women should be aware of the risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP).
The FDA has recently issued warning regarding the complications that arise following vaginal mesh surgery. Women who have mesh surgery may have an increased risk to other mesh-related complications-including repeat surgeries.
Women should ask their doctors about all POP treatment options.
Here are some example questions to ask your doctor:
Why is surgical mesh being chosen for me to repair my POP?
Are there alternatives to surgical mesh repair for POP? Non-surgical options?
What results have your other patients had with surgical mesh?
How many other surgical mesh procedures have you performed?
What can I expect to feel after surgery and for how long?
Which side effects should I expect after the surgery? Which are typical which are not? Which should I report to you?
Should a complication arise, who will treat it? A specialist? You?
What if the surgery doesn’t correct my problem?
Treatment Options for POP
For many women pelvic organ prolapse or POP is a serious issue. POP often occurs after childbirth, a hysterectomy or menopause. If a woman has no or mild symptoms she does not need treatment if she does not do anything that might worsen the prolapse. To avoid prolapse women can lose weight if necessary, avoiding lifting heavy objects, and quit smoking. Prolapse doesn’t always worsen over time, so there is not a need to seek surgical treatment unless symptoms worsen or are painful.
Pelvic organ prolapse surgery is the only definite way to relieve less mild symptoms and improve pain. However, to avoid surgery or delay surgery there are less invasive treatments available.
One option is Kegel exercises. Women with prolapse that have no symptoms can practice Kegel exercises to prevent the prolapse from progressing. Kegel exercises can strengthen the pelvic floor through a serious of exercises. In Kegel exercises the pelvic floor muscles are squeezed at the same time. Women should avoid contracting stomach muscles as this does not help to prevent prolapse. For real prevention 30–40 pelvic contractions should be done each day. These can be divided throughout the day. Each contraction should last for 3–5 seconds.
Another alternative is a vaginal pessary — a device similar to a diaphragm or cervical cap that’s inserted in the vagina to help support the pelvic area.
Women should consult their doctors before making any decisions based upon their health.
Pelvic Organ Prolapse
Pelvic organ prolapse also known as POP can occur when the muscles and ligaments supporting a woman’s pelvic organs weaken and the pelvic organs slip out of place. A vaginal prolapse can happen after menopause, childbirth or a hysterectomy.
Common symptoms of POP 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 and surgery is one way to fix it. 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.
Once a rarely discussed problem, POP, has now become a priority in women’s health. Today, physicians regularly screen patients for symptoms. By the age of 80, almost 10% of women will undergo surgery for POP.
The FDA has issued specific warnings regarding some of these surgeries. To learn more visit http://vaginalmesh.legalview.info/
Transvaginal Mesh Procedures Receive More Attention After FDA Warnings
After the FDA issued new safety information regarding transvaginal mesh implants the Surgical procedures that use this medical device to treat pelvic organ prolapse (POP) have been getting some attention. The warnings highlighted serious risks of complications following surgery that included pain, infection, bleeding, pain during sex, organ perforation, and urinary problems.
This procedure was approved by the FDA in 2004 after passing through some loopholes and not going through testing as a result of being similar to another medical device that was already on the market. However, evidence is mounting that there are serious risks involved and alternative treatments need to be sought. The FDA has cited medical research conducted over the last few years that show the dangers and complications of using transvaginal mesh.
Many studies find that there may be some benefit to the transvaginal mesh procedure in some cases, but that the rate of vaginal mesh erosion is high—occurring in about 15.6% of cases. Research has also found that major complications involving mesh erosion can cause patients significant pain. About 10% of women who undergo transvaginal POP repair with mesh experienced mesh erosion in the first 12 months following surgery. About half of these women had to undergo a second surgery and maybe even additional surgeries after that.
The use of transvaginal mesh has not proved more effective or better at treating POP than traditional non-mesh repair. It is recommended that patients discuss options with their doctors to decide which procedure is best for them.
OB and Gynecological Device Panel to Meet Regarding Mesh
The obstetrics and gynecology devices panel will meet next month to discuss and make recommendations regarding the safety issues that have arisen regarding vaginal mesh products. The panel will also discuss the effectiveness of the medical device following the FDA’s issued warning. The transvaginal mesh is inserted surgically and used for repair of pelvic organ prolapse (POP). The FDA will also attend this meeting to seek expert opinion about the device regarding the risks and benefits. Recent adverse events include vaginal erosion leading to pelvic pain and dyspareunia.
The committee will be asked to provide scientific advise and give clinical input on regulatory strategies for the transvaginal mesh including labeling improvements and postmarket surveillance studies.
Mesh not the best solution for vaginal prolapse
Transvaginal pelvic organ prolapse (POP) is a condition where organs can pass through the vaginal opening. Not only can one organ fall through but multiple can also pass through at the same time. Surgery is used to repair the walls of the vagina and vaginal mesh is one type of surgical performance that can be used to create support for the organ. However, the FDA has found that there are many complications that arise from surgical implantation of vaginal mesh.
Vaginal mesh is a medical device that is used to repair weakened or damaged tissue. The mesh can be made of synthetic materials, either absorbable or non-absorbable.
The FDA began issuing warnings as early as 2008. Linking complications that may be directly linked to vaginal mesh implantation. This summer the FDA issued an updated warning with an even stronger message. The new report is based on a review of published medical reports dated between 1996 up to 2011.
The FDA found that surgical mesh used to help POP surgery was not better than non-mesh repair and may even be harmful. There were a number of cases where the mesh eroded and caused pain, infection, bleeding, pain during sex, organ perforation, and urinary problems.
Who’s Monitoring This? (Vaginal Mesh)
Vaginal mesh has been used for years, and women have had problems for years. But the FDA just recently issued a warning for the surgical implantation of vaginal mesh kits for the common side effects that women get after surgery. Women undergo surgical procedures using mesh to repair pelvic organ prolapse or POP, but now it seems more problems are arising.
In 1976, when the FDA was given responsibility for medical devices, like vaginal mesh kits, Congress allowed that those medical devices that were already on the market could stay on the market without testing. Medical devices could also be cleared for the market if they were similar to existing products.
As a result, many medical devices have been on the market with the FDA’s approval just based on the fact that older similar devices cleared testing. Vaginal Mesh was put on the market in 1996, and was not subject to these tests because there was a similar devices before that went through the testing. This is still the process in place today. And today, there are numerous injuries caused by the vaginal mesh kits.
This process is only set in place to be an expedited approval process. There should be more that a medical device should go through before it is available to the public.