Transvaginal Surgical Mesh Complications
FDA: Serious Complications of Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
As recent as July 13, 2011 the FDA directed a serious alert to healthcare professionals in gynecology, urogynecology, general surgery, internal medicine, family practice and emergency medicine.
What is surgical mesh? 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.
What does the July 13, 2011 alert warn? An updated safety communication warned healthcare providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options. More importantly, the warning said that with exposure to greater risk comes no evidence of greater clinical benefit or an improved quality of life.
What is Pelvic Organ Prolapse? Pelvic Organ Prolapse or POP occurs when the tissues that hold the pelvic organs in place become stretched or weakened. When these organs become weak they drop and bulge or prolapse into the vagina. While not life-threatening, women with POP frequently suffer pelvic discomfort and disruption of urinary, sexual, and defecating functions — and an overall reduction in their quality of life.
What are symptoms?
- Pressure on your pelvis and vagina
- An annoying to distressing feeling that you haven’t fully empted your bladder
- Recurring bladder infections
- A bulge that protrudes through your vaginal opening but may go away when you lie down
- Loss of urinary control especially after sneezing and laughing
- Urinary leakage and pain during sexual intercourse
What is Trans Vaginal Mesh?
Trans vaginal mesh is a medical device that is implanted into the vagina.
More than 75,000 women received trans vaginal mesh implants last year to strengthen weak pelvic musclesthat fail to support internal organs. Patients claimed the trans vaginal mesh surgeries led to internal injuries. Hundreds of lawsuits have been filed against the trans vaginal mesh makers.
Is trans vaginal mesh safe?
Some doctors would like to see a registry to follow patients who already have implants. Also more clinical trials are needed to establish whether the benefits of trans vaginal mesh outweigh the risks.
While the mesh makers say their medical devices are safe, various surgeons have spoken out that trans vaginal mesh should be used in limited numbers and only by well-trained physicians on a limited number of specifically chosen patients who have a propensity for successful surgery.
Potentially painful and dangerous vaginal mesh surgery side effects have recently been in the news. For many people hearing news about the side effects for mesh lead to a more a basic question: what is vaginal mesh and do I have it?
Vaginal mesh is a medical device used to treat pelvic organ prolapse and stress urinary incontinence. A surgeon inserts the mesh into the vagina to support the bladder or internal organs. The problem with vaginal mesh often occurs when the mesh begins to erode through the vaginal walls and become exposed. Then potentially serious side effects including pain and infection may develop.
Are they still using Transvaginal Mesh?
Yes. Although the FDA has put on a safety alert about transvaginal mesh and hundreds of women have filed lawsuits for pain and suffering from these medical implants – doctors are still using transvaginal mesh and manufacturers are still making the gyno-urological mesh.
Doesn’t it make you wonder how many lawsuits are too many lawsuits?
Doesn’t it make you wonder what has to happen before a transvaginal mesh product is recalled?
Some of the mesh makers agree that – yes – there should be more oversight and more clinical trials but so far that has not happened.
Some of the surgeons associations agree that – yes – there should be more training for complex transvaginal mesh implants but that has not stopped them from continuing to do the surgery.
While many stakeholders agree that there is room for improvement, nobody has hit the pause button in order to improve the product until another transvaginal mesh solution is deemed safer.
According to their doctors, women need transvaginal mesh to be permanently implanted to reinforce their weakened vaginal wall to repair pelvic organ prolapse also known as POP or to support the urethra to treat urinary incontinence.
Pelvic organ prolapse happens when the pelvic organs such as the bladder, uterus and bowel, become so weak that the organs drop from their normal position and bulge or prolapse into the vagina.
Pelvic organ prolapse is not life-threatening. However, women with POP have pelvic discomfort, disruption of their sexual, urinary, and defecating functions, and an overall decline in their quality of life.
On the other hand, Stress Urinary Incontinence or SUI also deals with incontinence or bladder leakage, is caused by insufficient strength of the pelvic floor muscles. While very common, SUI is written off as a natural part of aging. Women of all ages are affected.
If left untreated or dismissed as a “just live with it” condition, SUI will put severe restrictions on a woman’s lifestyle.
In the United States, market data from manufacturers demonstrate that in 2010 approximately 300,000 women underwent surgical procedures to repair pelvic organ prolapse and approximately 260,000 women underwent surgical procedures to repair stress urinary incontinence.
Approximately one out of three pelvic organ prolapse surgeries used mesh and three out of four of these mesh procedures were transvaginal. So do the math, 80 percent were transvaginal mesh surgery.
So, how do you know if you have the bad mesh?
Based on data from 110 studies including 11,785 women, approximately 10 percent of women who had the mesh surgery experienced mesh erosion within one year of surgery.
If you feel fine and are not suffering any side effects or pain, you may not have the bad mesh. Many of the painful side effects occur within one or two years.
- You probably have the bad mesh if the mesh erodes through your vagina.
- You probably have the bad mesh if you suffer from painful urinary problems and the pelvic organ prolapse or stress urinary incontinence has returned.
- You probably have the bad mesh if both you and your sexual partner have painful intercourse.
There are other symptoms of bad mesh but these are the most prevalent.
The warning updated a previous 2008 warning that informed patients and physicians of the potential risks associated with transvaginal mesh devices and clarified that the FDA no longer considered transvaginal mesh complications to be rare.
Additionally, the FDA announced that the incidences of transvaginal mesh complications are higher than the incidents of complications for other types of surgery to repair pelvic organ prolapse or treat stress urinary incontinence.
How Common are Transvaginal Mesh Complications?
From January 1, 2008 – December 31, 2010 the FDA received 2,874 reports of transvaginal mesh complications. That is in addition to the more than 1,000 reports received from 2005 – 2007.
Risks Associated with Transvaginal Mesh Devices
The identified risks include, but may not be limited to:
- Internal bleeding
- Vaginal scarring
- Vaginal wall narrowing
- Urinary problems
- Mesh erosion in to vaginal tissue
- Pain during intercourse
- Recurrence of pelvic organ prolapse and/or stress urinary incontinence.
The FDA Recommendations
The FDA has not yet banned transvaginal mesh devices. However, the agency is urging doctors to recognize that in most cases pelvic organ prolapse can be treated without transvaginal mesh and to make sure their patients are fully informed of the risks they face. The FDA is also recommending that patients talk to their surgeons about options, be diligent about follow up care, and recognize the signs of a potential side effect so that they can seek prompt treatment.
If you have, or are considering, a transvaginal mesh device to treat pelvic organ prolapse or stress urinary incontinence, we urge you to heed the FDA warnings and talk to your doctor.
Uses of Transvaginal Mesh
In 2011, the FDA updated its 2008 warning abouttransvaginal mesh devices to inform women and their doctors about the serious risks associated with these medical devices. In order to understand whether you may have a transvaginal mesh or be at risk of getting a transvaginal mesh, it is important to understand when these devices are used.
As of October 2011, transvaginal mesh devices are still FDA approved to treat two conditions: pelvic organ prolapse and stress urinary incontinence.
Transvaginal Mesh Devices and Pelvic Organ Prolapse (POP)
Pelvic organ prolapse occurs when the pelvic organs weaken and slip out of place. This may occur after childbirth, menopause, a hysterectomy or at another time. The specific organs involve many include one or more of the following: bladder, urethra, uterus, vagina, small bowel or rectum.
The condition can be painful and significantly impact a woman’s quality of life. If the symptoms of pelvic organ prolapse are mild then no surgical treatments may be recommended. However, if the symptoms interfere with a woman’s quality of life then surgery may be recommended. Transvaginal mesh surgery is only one type of surgery that may be used to treat pelvic organ prolapse.
Transvaginal Mesh Devices and Stress Urinary Incontinence (SUI)
Stress urinary incontinence is the involuntary release of urine from the body. It may occur when a person laughs, exercises, sneezes or coughs, for example. Women who experience stress urinary incontinence often have weakened sphincter and/or pelvic muscles. The condition may occur because of a previous surgery, injury, as a side effect of some medications, or as a consequence of pregnancy and childbirth. The risk increases with multiple pregnancies and births.
Treatment often depends on how much of an impact the urinary incontinence if having on the patient’s quality of life. Treatment options include behavior changes, exercise, medication and in some cases surgery. Transvaginal mesh surgery is one surgical option for women with stress urinary incontinence, but it is not without risks.
To learn more about treatment for pelvic organ prolapse or stress urinary incontinence, please speak with your physician about your options.
What to expect after Transvaginal Mesh surgery
There has been a lot of transvaginal mesh news recently about the possible complications aftertransvaginal mesh surgery. After reading about all adverse effects of transvaginal mesh surgery you might be concerned about what you should expect after your own surgery.
Generally, you might expect to be discharged with pain medication and/or an antibiotic after your surgery. Within 2 -4 weeks you may be cleared to resume moderate activities and most women are able to resume their normal activities within 6 weeks of surgery.
However, even if you are feeling good 6 weeks post-surgery, it is important to keep up with regular checkups to make sure that there you do not suffer from any complications. Complications from transvaginal mesh surgery may be painful and dangerous. Talk to your doctor about the potential symptoms of bad vaginal mesh repair and what to do if you experience pain, discomfort, bleeding or other symptoms after surgery.
Patients who undergo POP repair with mesh are subject to mesh-related complications that are not experienced by patients who undergo traditional surgery without mesh.
Adverse events associated with transvaginally placed mesh can be life-altering for some women. Pain may continue despite mesh removal. Mesh-associated complications are — not — rare. The most common mesh-related complication experienced by patients undergoing transvaginal POP repair with mesh is vaginal mesh.
Based on data from 110 studies including 11,785 women, approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within one year of surgery.
More than half of the women who experienced erosion from non-absorbable synthetic mesh required surgical excision in the operating room. Some women required two to three additional surgeries.
Mesh contraction, causing vaginal shortening, tightening, and/or vaginal pain in association with transvaginal POP repair with mesh, is increasingly reported.
What’s available for POP treatment options?
If the symptoms are not too advanced, you will be advised to do Kegel exercises to strengthen your pelvis muscles. Other non-surgical options are estrogen therapy because estrogen helps keep pelvic muscles strong or using a vaginal diaphragm or large tampon to support the bladder and push it back into place.
Surgery to repair Pelvic Organ Prolapse can be performed through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy.
Doctors seem to prefer the transvaginal method. However, if you still want to get pregnant, avoid surgery although a Caesarian delivery is still possible. Vaginal surgical solutions are never guaranteed. While some may last for years, there is a great risk for recurrence because of the forces of gravity resulting in the stretching of tissues.
A small incision is made in the vaginal area and two small incisions are made through the skin in the groin area. Next, the transvaginal mesh extends from one incision toward the second incision to create a hammock of support around the urethra. The mesh sling is designed to add support and stabilize the urethra. With the “hammock” in place, normal urinary function may be restored. The mesh tension is adjusted so that the leakage of urine is reduced. After the positioning of the mesh, the small incisions in the groin area and the top of the vaginal canal will be closed and bandaged.
How big are the problems associated withtransvaginal mesh patches?
Consider this: In the United States, market data from manufacturers indicate that in 2010 approximately 300,000 women underwent surgical procedures to repair POP and approximately 260,000 underwent surgical procedures to repair stress urinary incontinence.
According to industry estimates, approximately one out of three POP surgeries used mesh patches and three out of four of the mesh POP procedures were done transvaginally. Over 80 percent were done transvaginally with mesh patches.
The potential for problems is great.
What are some transvaginal surgery mesh patch brands?
The mega medical device manufacturers are all represented:
Johnson & Johnson Calls for More Safety Studies
Now that the Transvaginal Mesh lawsuits have been filed and public awareness has been raised about this important issue, Johnson & Johnson has told the FDA that it supports additional safety studies being done and labeling changes to warn of potential risks. So far, the company does agree that their transvaginal mesh products should be classified as high risk or face more regulatory controls.
Brand names of Ethicon’s/ Johnson & Johnson transvaginal mesh patches include:
*Gynecare TVT Sling
*Gynecare Prolift Mesh
*Gynecare Prolene Mesh
Prolene Polypropylene Mesh Patch Secur
Growing Concern About Bard Transvaginal Mesh Products
In October 2008 and again in July 2011 the FDA warned women and their doctors of the potential dangers associated with transvaginal mesh implants. While the devices have not yet been recalled by the FDA, the concern about the risks are mounting.
Brand names of Bard’s transvaginal mesh patches:
BioSynthetic Support System,
Avaulta Solo™ Synthetic Support System,
*Pelvitex™ Polypropylene Mesh
Brand name of American Medical Systems: SPARC®*
Transvaginal mesh side effects have been identified by the FDA and reported in the media. As the number of reported injuries continues to grow, it is important to recognize the manufacturers and brand names of vaginal mesh.
Brand name for Boston Scientific transvaginal mesh patches:
Advantage™ Sling System
Lynx™ Suprapubic Mid-Urethral Sling System
Obtryx® Curved Single
Obtryx® Mesh Sling
Prefyx Mid U™ Mesh Sling System
Prefyx PPS™ System
* Mentioned in existing lawsuits