Transvaginal Mesh Discussions Part 2: Definitions and Descriptions

By Independent Staff Writer

What is Vaginal Mesh?
Although mesh was originally used in hernia repairs as far back as the 1950’s, it was not until the 1970’s that gynecologists began implanting this metallic or polymeric screen to reinforce and support weakened muscle and tissue and treat pelvic organ prolapse. In the 1990’s surgeons used the mesh to treat stress urinary incontinence although there was no “official” mesh product available at the time—surgeons simply cut the mesh to fit the surgical needs of their patients. Finally in 1996 a mesh kit was FDA approved for stress urinary incontinence and in 2002 the FDA approved a similar kit for pelvic organ prolapse surgeries. There are currently four types of mesh, including a non-absorbable polyester mesh (most commonly used), an absorbable synthetic mesh, a mesh made only of animal tissue, and there are meshes which are a combination of the three types above. Women who undergo surgery involving transvaginal mesh will generally have a spinal or general anesthetic. Incisions will be made inside the vagina, then the mesh implant will be placed under the vaginal skin with the expectation that the body’s own tissues will grow into the mesh in a matter of weeks, and the weakened tissues will be successfully reinforced. 

Bladder Sling vs. Transvaginal Mesh Implant
The bladder sling is used in the treatment of severe urinary incontinence. The materials used in the bladder sling surgery include Teflon, Gore-Tex and fibrous tissues taken from the rectum. The surgery can be done through a small incision in the belly button, vaginally, or abdominally. Many surgeons use the sling procedure for all forms of incontinence which affects some 13 million American adults, most of them women. Just like transvaginal mesh, however, the non-woven mesh bladder slings can not only inhibit the flow of oxygen into surrounding organs, it can block crucial nutrients from making their way past the sling material.  This can, in turn, lead to severe pelvic infections and even damage to surrounding organs. Bladder slings can cause many of the same damages that vaginal mesh can, and can negatively impact your future and quality of life. 

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Transvaginal Mesh Discussions Part 4: Revision Surgery

By Independent Staff Writer


Is Revision Surgery a Possibility in Your Case?
The degree of your symptoms and whether or not the mesh has eroded into the vaginal walls or another surrounding organ will likely determine whether you are a candidate for revision surgery. It is important that you discuss your options thoroughly with your physician before deciding to undergo revision surgery to correct the problems caused by your transvaginal mesh implant. Revision surgery can include removal of the mesh completely or corrective surgery to trim or resize the mesh implant. Revision surgery can lead to excessive scar tissue and in some cases may further aggravate the symptoms and it can be difficult to locate surgeons who are willing to perform the revision surgery. 

Is Revision Surgery Safe?
Any way you look at it, revision surgery is yet another serious surgery, and while generally not as extensive as the original mesh implant, your recovery time and your risks are equal. The surgeon will be required to make incisions, remove the mesh from surrounding tissues or organs, and suture the incisions. There will be swelling and discomfort, from mild to severe for several weeks, and you will be unable to return to work for at least two weeks. If you typically stand on your feet for long periods of time at your place of employment, it could be even longer before you can return. Many women note that with each successive surgery it can take longer to recuperate, and depending on the severity of the erosion or other medical issues, it could require several surgeries to fully correct your problems. Some women have recovery periods of up to six weeks with lifting restrictions even past the six week mark.

Will the Manufacturer of Your Transvaginal Mesh Implant Pay for Revision Surgery?
While those women whose transvaginal mesh implant has caused them significant medical harm could be eligible to file a lawsuit for damages, they will likely be responsible for all costs associated with testing and revision surgery, at least for the time being. If it is determined, however that they have a strong legal position regarding the flawed transvaginal mesh implant, an experienced personal injury attorney will work hard to obtain the maximum award provided for under the law to offset those expenses. While in theory every woman implanted with transvaginal mesh could have a legal claim, there must generally be specific damages to make litigations worth the financial cost and psychological trauma.

Transvaginal Mesh: Are There Safer Alternatives?

By Independent Staff Writer

In light of the recent lawsuits filed against manufacturers of transvaginal mesh implants, many are wondering whether a safer alternative to using the potentially risky mesh exists. Mesh has been used since the 1950’s, primarily for hernia surgeries which are performed abdominally. Surgeons began expanding the use of the mesh to include surgeries on women for pelvic organ prolapse or stress incontinence. Women who had given birth multiple times, undergone a hysterectomy or were in menopause often experienced difficulties when their internal organs prolapsed as a result of the overstretched muscles and ligaments. The mesh once used solely for hernia repair was now being simply cut to a different size or shape and used in these POP and SUI surgeries, where surgeons fashioned the mesh into a support for the prolapsed organ. As time passed, the surrounding tissues would grow into the mesh, creating a permanent solution to keeping the organs in their place.

Complications from Transvaginal Mesh
After decades of using the mesh in transvaginal applications, complications from the mesh began surfacing. After carefully reviewing adverse event reports as well as the handful of studies done on the safety of the mesh implants the FDA issued a safety warning in 2008 declaring that complications from the mesh implants were not as rare as once believed. In the past several years over 4,000 women have reported complications from the mesh, primarily a particularly serious issue known as erosion when the mesh works its way through the vaginal wall and even into other surrounding organs. Other complications include infection, chronic urinary tract infections and pain, ranging from moderate to chronic and severe.

Is There a Safer Alternative?
A wide range of research has been done regarding the benefits of one type of surgery over the other, with most results indicating that the use of mesh implants in POP or SUI surgeries is not superior to more traditional methods. Similarly, an FDA review of the scientific literature regarding vaginal mesh use in surgeries taking place between 1996 and 2011 found that transvaginal repair with mesh improves neither the end result nor the quality of life when compared to traditional, non-mesh repairs. One study, published in The New England Journal of Medicine found that the mesh approach rendered more effective relief of symptoms, however noted a higher incidence of subsequent complications from the mesh surgeries. Over 300,000 POP and SUI surgeries are performed each year in the United States, however many of the women undergoing these surgeries are not fully informed of the alternatives to mesh surgery as well as the possible complications.

Transvaginal Mesh Complications and Corrective Procedures: The Long Road to Recovery

By Independent Staff Writer

In the past few years more and more women are coming forward to report complications—some of them quite severe—which resulted from surgeries involving the use of transvaginal mesh implants. Mesh has been implemented in surgeries as far back as the 1950’s, when it was used in hernia repair over the more traditional suture repair, with excellent results. In fact, when the mesh procedure was used there was a significantly lower recurrence of the hernias.

Doctors soon began using the mesh in other applications such as the repair of pelvic organ prolapse and stress incontinence, simply cutting it to the size needed. Unfortunately, due perhaps to the difference in elasticity between the abdominal area  and pelvic area, many women have reported medical issues following their mesh surgery including severe infections, pain in the pelvic region, adhesions, mesh erosion, chronic urinary tract infections, bowel and bladder injuries, painful scarring, painful sexual intercourse, and even death in a few tragic cases.  Correcting these injuries can require one or more surgeries performed by a surgeon with training and experience in mesh injury surgeries.

Mesh Extrusion or Erosion
The most common complication of the transvaginal mesh placement occurs when the mesh breaks through the incision or the vaginal lining, resulting in bleeding, excess vaginal discharge, recurring urinary tract infections, drainage of urine into the vagina and can even cause pain to a male partner during intercourse. The exposed mesh as well as the surrounding injured vaginal tissue must be removed followed by pelvic reconstructive surgery. Some of the most highly skilled surgeons in the country are implementing a new surgical instrument known as the Plasma Blade in favor of the more traditional scalpel or cauterization devices, however it can be difficult to find a surgeon trained in using this innovative instrument.  

If the mesh has eroded into the bladder, it must first be removed, then the damage to the bladder and the vaginal wall must be repaired, usually through the abdomen with a fairly large incision and a relatively long recovery time. Depending on the extent of the erosion some doctors perform the procedure laparoscopically, which is typically an outpatient surgery done through a mini-incision in the belly button. Performing the repairs in this manner is considered an advanced procedure and should only be attempted by a surgeon who is highly experienced in the technique as well as the necessary pelvic reconstruction. Should the mesh have eroded into the bowel or rectum it is considered a very serious complication.

Transvaginal Mesh: Is an FDA Recall on the Horizon?

By Independent Staff Writer

Even though some consumer advocate groups—such as Public Citizen—have called for the FDA to ban the marketing of transvaginal mesh for use in surgeries such as the repair of pelvic organ prolapse and stress urinary incontinence as yet there has been no definitive conclusions reached as to whether the use of mesh should be permanently discontinued. The FDA has made physicians and the public aware of the potential risks involved in using transvaginal mesh including erosion, contraction or shrinkage of the mesh once it has been implanted, however now must decide whether further action is called for in light of the flurry of lawsuits regarding mesh complications.

It is highly unlikely that the manufacturers of the mesh will issue a voluntary recall, although the FDA may choose to elevate the approval process for the mesh from the moderate risk Class II to the higher-risk Class III. If the mesh device class is reclassified, manufacturers will face a much tougher process when gaining FDA approval and will also be required to conduct human trials.  A Class III is the highest risk category for medical devices however the FDA could conceivably bump up the existing class level without recalling existing devices. Finally, the FDA could issue sterner warnings regarding the mesh devices to both physicians and patients while allowing the device to keep the same approval process, meaning that new mesh products which are substantially equivalent to already-approved ones would be granted approval.

FDA Safety Recommendations
Currently the FDA has issued safety recommendations and warnings regarding the use of transvaginal mesh implants including:

• Patients who have pelvic organ prolapse surgery using mesh may be subject to complications which are not experienced by those undergoing more traditional forms of POP surgery without mesh.

• Placement of the transvaginal mesh patch may be life-altering for some women, and the chronic levels of pain can sometimes continue even after the mesh is surgically removed.

• Mesh-associated complications are not rare—approximately ten percent of women who undergo pelvic organ prolapse surgery with mesh experienced some level of erosion within the first year following the surgery.

• Erosion is the most common complication, and of the women who experienced erosion of the mesh into the vaginal wall or other organs, more than half required surgical excision of the mesh with some requiring multiple surgeries.

• Many women have reported mesh contraction which results in chronic vaginal pain or vaginal shortening.

• When mesh is used in stress urinary incontinence surgeries recurrence of the SUI is more common than in traditional repair which doesn’t use mesh.

• When mesh is used to perform a pelvic organ prolapse surgery abdominally, it appears to have lower rates of complications as compared to transvaginal surgery with mesh.

• As far as effectiveness, the FDA states that transvaginal repair with mesh does not appear to provide any added benefits compared to more traditional surgeries without mesh.

The FDA goes on to state, however that so far the adverse events which resulted from transvaginal mesh surgeries were both inconsistently defined and reported, that very few of the existing studies extended longer than two years, and that the studies which exist tend to be poorly designed, poorly conducted and fail to account for variable patient follow-up length. The results from the few studies which exist reflect both primary and repeat prolapse repairs which could skewer the overall results.

Transvaginal Mesh Lawsuits: What You Need to Know

By Independent Staff Writer

If you are a woman who has had a surgery in the past for stress urinary incontinence or pelvic organ prolapse, and you think your surgeon might have used a mesh implant during that surgery, you need to know the facts surrounding the mesh products. While highly similar mesh products have been used in surgical applications for decades—primarily in hernia surgeries—it was not until 1996 that mesh was approved for use in SUI surgeries and 2002 when the mesh was FDA approved for use in POP surgeries. Up until that time surgeons simply adapted the mesh used in hernia surgeries to suit other surgical applications.

Flaws in the Approval Process?
The mesh was able to be implanted into the vaginal wall without the necessity of prior controlled human studies through a sort of governmental loophole known as a 510(k) clearance approval. This type of less-stringent approval process allows a quicker approval without the necessity of clinical trials for medical devices which are substantially equivalent to already-approved devices. What was not anticipated, however, was the differences in pelvic region tissue as opposed to abdominal tissue. The fragile tissues in the pelvic region tend to be much more flexible, therefore the relatively inelastic mesh which works well in the abdomen tends to pull at the surrounding areas and erode through the more delicate tissues. 

Mesh Manufacturers on the Hook?
The transvaginal mesh surgeries are performed on as many as 70,000 women each year, leaving these women vulnerable to potential complications. The manufacturers of the mesh implants are currently the target of over 4,000 lawsuits under the belief they sidestepped their legal duty to ensure the mesh products were properly designed, tested and manufactured. Although some consumer advocate groups are calling for a recall of all mesh products when used in implantation in the vaginal wall, the American Congress of Obstetricians and Gynecologists have yet to reach a final conclusion as to whether mesh use in this application should be entirely discontinued. The FDA, while recognizing the risks of vaginal mesh are presently considering several options with an ultimate goal of protecting women from harm. The Journal of Obstetrics & Gynecology published the results of a randomized controlled trial in August of 2010 regarding the use of mesh for pelvic organ prolapse. At three months, there was a 15.6% vaginal mesh erosion rate with “no difference in overall objective and subjective cure rates.”

Transvaginal Mesh: A Brief History of the Problematic Implant

By Independent Staff Writer


While the past three years have brought an influx of complications and problems related to the transvaginal mesh implant, the device has actually been in use for over half a century. Surgical mesh made of metallic or polymer screens was developed for use in abdominal hernia surgeries in the 1950’s, however gynecologists soon saw the advantages of using the mesh in the surgical repair of stress urinary incontinence and pelvic organ prolapse. These problems are relatively common among women who have had children, undergone a hysterectomy or are post-menopausal. During such events, the muscles and ligaments which surround the pelvic organs can weaken, allowing those organs to slip out of their natural place, or prolapse.

FDA Approves Surgical Mesh for Abdominal Surgeries
Surgical mesh was originally approved for abdominal applications; since pelvic organ prolapse surgeries were performed abdominally in the 70’s, the mesh appeared to be a good solution for POP surgeries as well. Prior to the development of mesh, hernia repair was performed using suture techniques which garnered recurrence rates from 24-54%. Once the mesh began to be widely used to repair hernias, the recurrence rates dropped to 10-20%, however placement and fixation of the mesh was crucial for a positive outcome. In the late 1980’s surgeons began positioning the mesh with an overlap of 5 cm in all directions around the hernia defect, and the recurrence rates dropped as low as 3.5%.

Transvaginal Use of Mesh
Following several decades of success in using the mesh implants, the 1990’s brought such great advances in surgical techniques as well as in the mesh technology itself that gynecologists began using the mesh in both SUI and POP transvaginal surgical procedures. At this time there was still no “official” surgical mesh product available for these procedures, therefore the surgeons simply cut the mesh themselves whenever they used the abdominal mesh in vaginal applications. Manufacturers of the mesh saw an opportunity, and began producing kits which included both the mesh as well as tools which supported the surgical delivery and insertion.

FDA Approval for Transvaginal Use
Actual FDA approval of the mesh for transvaginal surgeries did not take place until a mesh developed by Boston Scientific was approved in 1996 for use in stress urinary incontinence surgeries. Unfortunately, the year following that approval saw problems with this particular mesh product with over 120 patients reporting serious side effects. Even though Boston Scientific’s ProteGen was voluntarily pulled from the market in 1999, the manner in which FDA approval was granted allowed subsequent products to be approved using the ProteGen as a predicate device.  Even though surgeons had been using mesh in pelvic organ prolapse surgeries for many years, it was finally granted FDA approval for this particular application in 2002.

Unexpected Problems Arise
Although for the most part the mesh products worked well in the areas of the abdomen which were limited in flex, the pelvis has a much different physiology. Pelvic regions such as the vagina tend to be highly flexible and much more delicate than the abdomen, and the stiff, inelastic mesh did not work as well with the fragile tissues. In many cases the mesh would shrink and become rigid, pulling at the delicate surrounding areas and even eroding through the tissue walls.

Transvaginal Mesh and the FDA: How the Food and Drug Administration

By Independent Staff Writer 

Surgical Procedures Using Mesh

Mesh has been widely used in a variety of surgeries since the 1950’s, and was originally approved for use in abdominal hernia surgery.  Surgeons began altering the size and shape of the mesh devices, using them in women’s surgeries for pelvic organ prolapse and stress urinary incontinence. It was not until 1996 that the mesh was approved specifically for SUI surgeries and 2002 when it was approved for POP surgeries. 

Mesh Complications

The FDA issued their first public health alert in 2008 detailing the potentially serious complications associated with the transvaginal placement of surgical mesh when used to repair pelvic organ prolapse or stress urinary incontinence. The agency then updated the original warnings stating that mesh complications in transvaginal repair of pelvic organ prolapse were actually not all that rare. They continued the warning by stating that when compared to traditional, non-mesh repairs for pelvic organ prolapse, there are no apparent benefits to using mesh.

To date, the FDA has received as many as 4,000 reports of serious complications associated with the mesh implant, particularly when used in the transvaginal repair of pelvic organ prolapse. These reported complications cover the period from January, 2005 through December, 2010, with almost three-fourths of those in the past three years. Many believe the numbers will continue to climb; a 2009 review in the International Urogynecology Journal stated the complication rate from use of vaginal mesh was from 7%-25% with those who smoked increasing that already high risk of complications as much as three times. 

Clinical Trial Stopped

Following the FDA’s warnings, a 2010 clinical trial which compared traditional surgical procedures used in repairing pelvic organ prolapse to transvaginal mesh procedures was halted before completion due to complications in over 15% of the patients whose surgery included mesh. The primary complication was mesh erosion, a serious and even potentially fatal medical injury which typically requires one or more surgeries to correct and repair. Regarding this study one of the lead authors of the report stated that in the end not only were there more complications, but the mesh didn’t prove to work any better than traditional surgery. 

Is Inappropriate Selection of Patients an Issue in Mesh Damages?

Some believe that one of the primary problems in the mesh controversy is the criteria used to select patients for the transvaginal mesh surgery which repairs pelvic organ prolapse.  Because the mesh device seemed so promising for women suffering from pelvic organ prolapse it may have been inappropriately used for younger, active women who could have received greater benefits from alternative types of non-vaginal surgery. Mesh surgeries are more appropriate for use in older, less sexually active women who either cannot undergo abdominal surgery or who has suffered a recurrent prolapse after a past surgery.