Hundreds of women suffering from mesh injuries have filed vaginal mesh lawsuit claims against Johnson & Johnson, C.R. Bard, and other manufacturers. Many other women will likely follow suit as their implants fail. Below, we’ll introduce some of the serious complications experienced by women who underwent transvaginal placement of mesh for POP and SUI repair. We’ll also describe the measures taken to correct the problems.

Transvaginal Mesh Implant Side Effects

Surgeons have installed pelvic mesh implants to repair hernias since the 1950s. They began using the devices to correct pelvic organ prolapse in the 1970s. Back then, the implants were cut to fit the anatomy of the patient, and installed through incisions made into the abdomen.

It wasn’t until twenty years later that surgeons began to install the devices through the vaginal tissue. The first mesh product designed specifically for SUI repair was approved by the FDA in 1996. The first device designed for POP repair was approved in 2002. Both were soon incorporated into “mesh kits” that included various tools for the installation and anchoring of the devices.

A large percentage of the surgery mesh complications that have resulted in lawsuits are associated with the kits designed after 2002. The FDA has received thousands of complaints detailing a range of side effects, including vaginal bleeding, chronic pain, infections, and exposure of the device in the vaginal canal. This latter circumstance, known as erosion or extrusion, was the most commonly reported vaginal mesh complication. In some patients, it has caused severe pain that has lowered their quality of life.

Many women also reported experiencing bowel and bladder perforations during the placement procedure. These injuries were caused by the tools used to implant the mesh device behind the vaginal wall. According to the FDA, at least two women have died as a result of organ and blood vessel perforations.

Correcting Vaginal Mesh Erosion/Extrusion

Erosion occurs as the implant moves through the vaginal tissue. A portion may eventually become exposed in the vaginal canal, causing infection, pain, and vaginal leakage of urine. In many cases, the exposed device can cause irritation to a man during sex.

If mesh erosion occurs shortly after implantation, some doctors prefer to allow the tissue to fully heal before taking corrective measures. The hope is that scar tissue will form and cover the exposed segment over two or three weeks. If this fails to happen, surgery is performed to remove the implant. In cases where its removal is impossible, the exposed portion is cut away.

Addressing Recurrent Urinary Tract Infections

Urinary tract infections (UTIs) are not uncommon following surgery to correct POP and SUI. This is the case regardless of whether the placement of the implant is performed via the vaginal tissue or abdominal incisions. These can usually be resolved with antibiotics.

That said, one of the reported bladder sling surgery complications experienced by women is recurrent UTIs, some of which prove resistant to antibiotics. In such cases, the implant often needs to be removed.

Treating Chronic Pain From Vaginal Mesh Complications

Pain in the vagina, pelvis, back, buttocks, and legs can result from a number of surgical mesh complications. For example, as described earlier, erosion (or extrusion) can result in vaginal pain. Mesh contraction and vaginal shortening – problems reported by the FDA in 2011 – can pose similar results. Infections of the bladder and throughout the urinary tract can cause pain in the pelvis and abdomen.

Sometimes, the pain that surfaces after vaginal placement of mesh occurs because the implant is installed too tightly. In such cases, it must be loosened, which requires surgery. If pain persists past the normal recovery stage, and tension is not the cause, the implant may need to be surgically removed.

If you received a pelvic mesh implant and have suffered pain, bleeding, infection, or erosion, you may be able to file a vaginal mesh lawsuit claim. Contact a transvaginal mesh lawsuit attorney to discuss your case.

Mesh has been used to repair urethral problems associated with SUI since the 1990s. The FDA approved the first mesh device specifically designed for this purpose in 1996. It wasn’t long before reports of complications began to surface. Boston Scientific’s ProteGen Sling, approved by the FDA in 1997, attracted a number of complaints. It was withdrawn from the market less than two years later. Another vaginal sling, called ObTape, likewise drew intense criticism. In 2006, it too was pulled from the market.

These two medical fiascos were merely the beginning. There remain other bladder slings on the market designed for vaginal installation that continue to cause serious injuries. Women who have received one of these implants to relieve symptoms of SUI, and developed vaginal mesh complications, are encouraged to contact a pelvic mesh lawsuit attorney.

Stress Urinary Incontinence: Causes And Side Effects

Millions of women suffer from SUI. The condition is defined by the involuntary loss of urine when pressure is placed on the abdomen. This can happen when women laugh, cough, or exercise. The condition’s severity differs by patient.

The leakage is due to a weakening in the muscles that control the flow of urine. Normally, urine is stored in the bladder until a person feels the urge to urinate. At that time, the muscles in the bladder’s wall contract, pushing urine into the urethra. It flows through the urethra and exits the body.

Prior to urination, the urethral sphincter, two muscles that encircle the urethra, tighten around the tube to prevent urine from passing. With SUI, these muscles are incompetent. They cannot tighten sufficiently, and thus allow urine to leak. Women who first notice the problem may start to wear dark clothes, or use sanitary napkins, to hide the effects. But the problem usually worsens with time, and warrants medical treatment.

Bladder Sling Procedure To Correct SUI

It’s important to note that stress urinary incontinence is not caused by a problem with the bladder. The issue is with the urethra – specifically, the inability of the urethral sphincter to seal off the opening of the urethra. The procedure to correct SUI involves installing a sling underneath the tube. The sling functions like a hammock, applying pressure on the underside of the urethra. The pressure prevents involuntary leaks.

Traditionally, the surgical mesh was implanted through abdominal incisions. The procedure later evolved to installing the mesh strip through an incision made into the vaginal wall. The ends were then pulled through abdominal incisions. Today, the device is usually implanted entirely through the vagina. The ends of the mesh strip are anchored into the obturator internus muscles.

The entire operation can usually be completed in less than an hour. However, as noted, the vaginal mesh sling has been linked to serious side effects.

FDA Warns Of Bladder Sling Complications

The FDA became aware of a problem when nine surgical mesh manufacturers forwarded over 1,000 reports of complications. The reported issues were associated with transvaginal mesh placement to correct SUI and pelvic organ prolapse (POP). Women complained about infection, pain, bleeding, and erosion of the device. Many had also experienced a recurrence of their incontinence. In 2008, the FDA noted that although the complications could lead to serious consequences, they were “rare.”

In 2011, a second warning about vaginal mesh placement was issued. In the three-year period leading up to that point, the FDA had received nearly three times as many adverse event reports. Given this dramatic rise, the side effects – pain, bleeding, infection, erosion, etc. – were now defined as “not rare.” This admission spurred hundreds of women to file transvaginal mesh lawsuits against the manufacturers.

If you have suffered from bladder sling complications, we urge you to contact us to discuss pursuing a surgical bladder sling lawsuit settlement. You may be eligible to recover compensation for your injuries and accompanying medical bills. Contact us at your earliest convenience.

Below, we’ll describe the most common problems reported to the Food and Drug Administration over the last several years. The FDA announced in July 2011 that the following complications were “not rare” in cases where mesh was placed transvaginally for POP repair. It was after this disclosure that the number of vaginal mesh lawsuit claims began to rise dramatically.

Surgery Mesh Erosion Through The Vaginal Wall

The FDA reviewed literature regarding the safety and effectiveness of surgical mesh placement through the vagina. The literature covered procedures performed between 1996 and 2011. The agency found that the most commonly reported problem was vaginal mesh erosion (sometimes called extrusion).

Erosion occurs when the mesh device moves through the vaginal wall. In some cases, a piece of the product is exposed vaginally, and can be observed with the unaided eye. It can also be felt – and sometimes will cause discomfort for men – during sexual intercourse. Vaginal mesh extrusion usually causes pain and bleeding. Women may also notice a discharge.

In cases where the piece of exposed mesh is small, the tissue of the vagina may grow over it. Because further extrusion is possible, however, surgeons usually recommend that the device be removed. Unfortunately, the FDA noted in July 2011 that its removal is sometimes impossible, even with multiple surgeries.

Vaginal Mesh Erosion Into The Bladder Or Rectum

Far less common is extrusion of the device into the tissue of the bladder or rectum. These cases are more serious than vaginal mesh erosion. A device that erodes into the wall of the bladder may cause blood to seep into the urine (hematuria) as well as recurring urinary tract infections. If the mesh erodes into both the bladder and vagina, a fistula may form between the organs. This can allow urine to drain into the vagina.

Rectal mesh erosion is particularly dangerous. It can cause fecal matter to drain outside the rectum, leading to infection. The woman will likely experience severe pain, and may notice the presence of blood during bowel movements. A device that erodes into both the vagina and rectum can cause a fistula to form between them. Stool will thus be able to drain into the vagina.

Both bladder and rectal mesh erosion require that the product is surgically removed. Because of the organs’ positions in the pelvis, abdominal surgery is usually necessary.

Mesh Contraction (Shrinkage)

Contraction of the device means that it shrinks after implantation. The condition is usually accompanied by vaginal shortening, tightening, and pain. Researchers for a study published in the February 2010 issue of Obstetrics & Gynecology stated that mesh contraction is associated with severe vaginal pain and morbidity. It requires removal.

The FDA noted that mesh contraction did not show up in scientific literature prior to October 2008. Thus, they did not report the problem in the public health notification announced at that time.

Pain During Sexual Intercourse (Dyspareunia)

Women who have received mesh vaginally often suffer from pain during sex, a condition known as dyspareunia. In most cases, this is due to extrusion or contraction of the device. Given that the product’s removal is not always possible, dyspareunia may become permanent for many women.

Recurring Vaginal Infections

Infections are attributable to vaginal mesh erosion and contraction. They can be managed with antibiotics, but like dyspareunia, may become a lifelong problem if the device cannot be removed.

As noted earlier, hundreds of vaginal mesh lawsuit claims have been filed against some of the manufacturers. Many more are expected. If you received a vaginal mesh implant and have suffered any of the bladder sling failure complications described above, you may be eligible to file a claim for compensation. Contact a transvaginal mesh lawsuit lawyer to discuss your options.

The manufacturers of the failed implants have come under intense scrutiny and criticism since the FDA’s warning. The agency has ordered 33 companies to track the safety and effectiveness of their devices as part of a postmarket study project. Additionally, hundreds of vaginal mesh lawsuit claims have been filed by women suffering from a variety of injuries. Complaints describe complications such as vaginal pain, recurrent urinary tract infections, pain during sex, and even recurrent prolapse.

Most of the women who have chosen to undergo vaginal over abdominal placement of the implant did so with certain expectations. They believed the procedure would be less painful, pose a shorter recovery period, and yield similar – or even better – results than other forms of treatment. Unfortunately, many have discovered the opposite is true.

Vaginal Mesh Complications: Rare Or Not Rare?

The FDA’s first safety announcement about transvaginal mesh failures was issued in 2008. Prior to that point, it had received over 1,000 reports of adverse events stemming from transvaginal placement of the implant. Despite the relatively high number, the agency noted that complications were rare. That claim has turned out to be untrue.

From the beginning of 2008 through the end of 2010, the FDA received 2,874 additional complaints of surgical mesh complications. To be sure, an increase in the number of adverse event reports is not uncommon after a safety warning is announced. More people become aware that a particular medical device is associated with problems, and file complaints describing their own experiences with it. However, the number of complaints received by the FDA was higher than expected. In 2011, the agency reversed its previous position by noting that the complications were “not rare.”

Does Transvaginal Mesh Placement Lead To Better Results?

Another important detail disclosed by the FDA was that there was no evidence that vaginal placement of the implant provided better results than traditional therapy. Nor was there evidence that patients who underwent the procedure enjoyed a higher quality of life down the road. In fact, the FDA noted that transvaginal placement exposed women to risks that were not an issue with traditional treatment.

These disclosures countered the expectations of many women, who believed vaginal mesh placement for POP repair was their best option. Not only did the procedure introduce new risks, but it failed to offer improved results.

What To Do If You Received A Surgical Mesh Implant

In the event you have already undergone transvaginal POP repair with mesh, it is important to make regular follow-up appointments with your physician. Inform him or her about uncharacteristic spotting or other types of vaginal discharge. Also, notify your doctor if you experience persistent vaginal or pelvic pain, recurrent urinary tract infections, or pain during sexual intercourse.

If you underwent surgery for POP repair, and are uncertain whether you received surgical mesh, ask your doctor at the hospital in which the procedure was performed. The complications described earlier can appear at any time. You should know in advance whether a mesh implant may be to blame.

Hundreds of thousands of women have chosen to undergo transvaginal mesh surgery for POP. They expected to experience relief from the discomfort caused by prolapsed organs. Instead, many have suffered from serious surgical mesh complications that have lowered their quality of life.

If you underwent vaginal placement of pelvic mesh, and have suffered vaginal bleeding, infection, pain, and other side effects, you may be eligible to file a claim for compensation. Contact an experienced vaginal mesh lawsuit settlements lawyer to discuss your legal options and for the latest surgery mesh recall news.

The FDA issued a safety communication in July 2011 describing complications as “not rare.” In September 2011, BusinessWeek reported that two mesh manufacturers face nearly 500 vaginal mesh lawsuit claims. Currently there is no surgery mesh recall covering all of the different products used in surgical repairs.

To understand the consequences of surgical mesh failures, it’s important to be familiar with the conditions it is used to correct. The most common applications include treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). We’ll describe both conditions in the space below.

Vaginal Mesh Repair For Pelvic Organ Prolapse

The organs in the pelvis, including the bladder, rectum, uterus, and small bowels, are normally contained by muscles and ligaments. With pelvic organ prolapse, this support structure weakens. This allows one or more pelvic organs to fall, bulging against the vagina.

POP can present in several ways depending on the organs that are involved. For example, a prolapsed bladder (called a cystocele) pushes against the anterior (front) wall of the vagina. A prolapsed rectum (rectocele) bulges against the posterior (back) vaginal wall. A prolapsed uterus (uterine prolapse) and small bowel (enterocele) allow the organs to herniate into the top of the vagina.

There are several treatment options available for pelvic organ prolapse, including drug therapy and physical therapy. Severe cases are usually addressed with surgery. A surgeon may remove extra tissue and reposition prolapsed organs. Surgical mesh is installed – either transvaginally or through the abdomen – to help support the organs, and prevent them from falling in the future.

As long as the mesh stays in place, problems rarely occur. However, vaginal placement of surgical mesh for POP repair has been known to cause major complications. The FDA’s 2011 safety communication lists surgery mesh erosion as the most common side effect reported by women. The failed device can erode into and through the walls of the vagina, rectum, bladder, and small intestine. Erosion into the rectum or small bowel is particularly serious since it can cause stool leakage and infection.

Correcting the problem requires a surgical resection of the mesh, and repair of the damaged organ. The FDA notes that some cases of vaginal mesh erosion cannot be resolved, despite multiple surgeries.

Other complications of mesh failure include vaginal bleeding, pain during intercourse (dyspareunia), aching in the lower back, and chronic vaginal infections. Additionally, when the mesh fails, many women experience a recurrence of prolapsed organs.

Vaginal Mesh Repair For Stress Urinary Incontinence

Stress urinary incontinence is characterized by an unintentional loss of urine. The muscles that normally control the release of urine (i.e. the sphincter and detrusor) become damaged or weakened, and fail to work properly. Abdominal pressure – which can be caused by sneezing, laughing, or coughing – forces urine to exit the bladder.

As with POP, there are several methods doctors can use to correct stress urinary incontinence, including medications, pelvic muscle training, and surgery. One of the most common surgical procedures involves the placement of surgical mesh. The mesh is placed midway in the urethra in order to provide support, and prevent unintended leakage of urine.

Here again, the device can erode, causing severe infection and pain. Erosion usually requires the removal of the device.

The majority of the transvaginal mesh lawsuit claims that have been filed thus far focus on complications arising from mesh installation for POP repair. Failure of the device in such circumstances poses serious complications, including erosion into the walls of the vagina and pelvic organs. In cases where the failed device cannot be surgically removed, the patient may be forced to live with chronic pain, recurring infections, and other consequences.

If you received a transvaginal mesh implant and have suffered pain, infections, and other surgery mesh complications, you may be eligible to file a claim for compensation against the manufacturer. Contact a bladder sling lawsuit lawyer to discuss your case.

Following on the heels of the FDA’s announcement, several transvaginal mesh lawsuit claims were filed throughout the U.S. The number of lawsuits continues to grow. To understand the motivation behind them, it’s important to be familiar with the injuries reported by women who have undergone vaginal mesh surgery for POP and SUI repair.

Overview Of POP And SUI

Pelvic organ prolapse occurs when the organs in a woman’s pelvis drop (or prolapse) from their positions. The condition is caused by a laxity in the muscles and ligaments that normally hold the organs in place. When the bladder, rectum, or small bowel fall, they press against the wall of the vagina. If the uterus falls, it drops into the vaginal canal. Pelvic mesh is placed through the vaginal wall to provide support for the fallen organs and prevent further damage.

Stress urinary incontinence is also due to muscular laxity. The muscles of the urethral sphincter – a valve that constricts to prevent the passage of urine – weaken. As a result, sudden pressure (e.g. a cough, laugh, etc.) can cause an involuntary urine leak. A bladder sling is transvaginally placed to provide support to the urethra.

Vaginal Bleeding And Urinary Tract Infections

Bleeding is a common problem that can occur if the vaginal tissue fails to hold the pelvic mesh in place. The device may move through the tissue (a condition called erosion), causing hemorrhaging. The bleeding may become persistent, in which case prompt medical care should be sought.

Many women have also suffered recurring urinary tract infections. These too might stem from migration of the device through the vaginal tissue. Bacteria may spread to the bladder and kidneys, leading to infections in both areas. If substantial bacteria enter the bloodstream, it can be life-threatening.

Painful Sensation During Sexual Intercourse

Known as dyspareunia, pain during sex is common with women who have received a mesh implant through the vaginal wall. In most cases, it is due to erosion, or extrusion, of the implant. A segment of the device can often be seen in the vaginal canal, and felt by a woman’s sexual partners during intercourse. The pain is often so severe that many women have been forced to abandon sex altogether.

Shrinkage (Contraction) Of Surgical Mesh

There have been numerous reports that the medical device shrinks after it is installed. Its contraction can lead to shortening and tightening of the vagina, both of which can cause severe vaginal and pelvic pain. The pain is usually constant, and only disappears after the device has been removed.

Organ Perforation During Vaginal Mesh Surgery

The FDA mentioned in its 2011 safety announcement that perforations of the bowel, bladder, and blood vessels had occurred in some patients during surgery. In two cases, the patients died. The cause of the perforations may be related to the space limitations of the area in which the device is implanted.

Surgical Mesh Complications Include Implant Erosion

As described earlier, erosion refers to the migration of the device through the body’s tissues. According to the FDA, this problem is the most frequent pelvic mesh complication reported. Most cases involve the implant moving through the vaginal mucosa toward the vaginal canal. Occasionally, however, the mesh device will move in the other direction, into the prolapsed organ.

For example, if the bladder has fallen from its place, the implant may erode into it. In addition to pain, the patient may notice blood in her urine. She might also develop a severe urinary tract infection. If the rectum is prolapsed, the implant may migrate through its tissue. This can cause serious infection, especially if stool is allowed to escape.

Most vaginal mesh complications following bladder sling surgery recovery can be resolved by removing the implant. In some cases of erosion, however, doing so may not be possible.

If you received a mesh implant and have suffered pain, bleeding, infection, or erosion, you may be able to file a vaginal mesh lawsuit. Contact a bladder sling lawsuit attorney to discuss your case.

The number of reports describing serious pelvic mesh complications has escalated in recent years, particularly so after a warning was issued by the FDA in 2008. This has prompted the agency to not only look more closely into the risks, but to reevaluate the process by which the devices were approved. Below, we’ll explain the reasons for which mesh is implanted, and describe the most common problems reported by women. You’ll also learn about the process of filing a transvaginal mesh lawsuit claim in the event you experience complications.

Transvaginal Placement Of Mesh To Repair POP And SUI

Mesh is surgically implanted to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The former condition occurs when muscles in the pelvic floor weaken, allowing one or more organs in the pelvis to drop from their normal positions. These organs, which may include the bladder and rectum, bulge into the vaginal wall. In the case of uterine prolapse, the uterus drops into the vaginal canal.

Stress urinary incontinence is a condition in which the muscles that control the flow of urine weaken. As a result, activity that exerts sudden pressure against the bladder (e.g. a sneeze, cough, etc.) produces an involuntary leak. SUI is often accompanied by some form of prolapse.

Pelvic mesh is implanted to provide support to the vaginal wall and prolapsed organs. Years ago, the device was placed through abdominal incisions. Today, a majority of women opt for vaginal placement; the device is implanted through incisions made into the anterior or posterior vaginal wall.

Vaginal Mesh Complications Reported By Women

From 2005 to 2007, the FDA received over 1,000 reports of problems that occurred following vaginal placement of mesh. This spurred the regulatory agency to issue a public health notification in 2008. From 2008 to 2010, they received an additional 2,874 reports describing “adverse events.” Although an increase in complaints is expected after an initial warning, the FDA admitted concern that the number was so high.

Women and their physicians reported that surgical mesh implanted transvaginally often led to urinary dysfunction, vaginal bleeding and discharge, infection, and pain during sex (known as dyspareunia). Some women suffered bladder and bowel perforations caused during surgery. Others experienced neuromuscular problems that led to muscle weakness and muscle pain.

Still other women reported that the bladder sling had begun to move through the vaginal wall, often to the point of being viewable in the vaginal canal. This problem is known as erosion, and can often cause pain that becomes debilitating. The only solution is to remove the device, which the FDA has noted is sometimes impossible.

Stages Of A Vaginal Mesh Lawsuit Claim

While each bladder mesh lawsuit is unique, most begin with a complaint made to the company that designed the device. The complaint may include a claim that the product was negligently designed; the company failed to monitor literature regarding mesh side effects; or they violated laws designed to protect the public’s safety.

If the mesh manufacturer denies its role as described in the complaint, an investigation is conducted. During this stage (called discovery), exhaustive research is performed to uncover every relevant detail about the bladder sling. This stage of the lawsuit may include interviews, depositions, and motions to induce the mesh manufacturer to provide information.

In the event that a vaginal mesh lawsuit settlement cannot be agreed upon, the case may be presented to a judge and jury. A ruling made in your favor will detail the compensation to which you are entitled for your injuries. This includes compensation for lost wages, costs related to hospitalization and treatment, and pain and suffering.

If you received a pelvic mesh implant and have suffered vaginal bleeding, pain, or other complications, you may be eligible to file a claim against the manufacturer. Contact a transvaginal mesh lawsuit lawyer to discuss your case and for the latest bladder sling recall news and information.

The complications reported to the FDA have been wide-ranging and serious. In some cases, they are unresolvable. While there has been no transvaginal mesh class action lawsuit filed in the U.S., hundreds of cases have been filed individually. We’ll explain some of the factors that have prompted these lawsuits below.

Broad Range Of Vaginal Mesh Failure Side Effects

Pelvic organ prolapse and stress urinary incontinence affect millions of women. Both conditions can be treated in various ways. When surgery is an option, the procedures are usually invasive. Transvaginal placement of surgical mesh was introduced as a less-invasive approach to treating POP and SUI. Patients were told they could expect a faster recovery, less postoperative pain, and less scarring. While these benefits were realized (due to the nature of minimally-invasive surgery), many women developed severe complications after the procedure.

Some patients have reported vaginal bleeding. Others have suffered from recurring vaginal infections. Still other women have experienced pain during sexual intercourse as well as intermittent pain unrelated to sexual activity. Side effects from transvaginal mesh placement also include difficult bowel movements, pain in the lower back, and a sensation that something has been pushed from the vagina.

Following the Food and Drug Administration’s 2008 safety notification about vaginal mesh complications, the agency reviewed literature involving the procedure and its effects. They noted the most common issue reported was mesh erosion. The medical device, after it had been installed transvaginally, often eroded into, and through, the wall of the vagina. The FDA also noted that surgery to address surgery mesh erosion and remove the medical device was sometimes unsuccessful. That is, the defective pelvic mesh could not be withdrawn in some cases.

High Rate Of Bladder Sling Complications

All medical devices are susceptible to possible failure. Manufacturers are expected to minimize the risk, thereby lowering the failure rates for their respective products. The failure rate that accompanies transvaginal mesh placement for POP repair is reportedly higher than average.

In August 2010, a study was published in the medical trade journal Obstetrics & Gynecology. Researchers had intended to conduct clinical trials on vaginal mesh placement for prolapse repair. They reported that they were forced to stop one trial due to the device failing in over 15 percent of cases. The main cause of failure was mesh erosion.

The FDA indicated that abdominal placement of mesh for POP repair may result in fewer complications compared to vaginal placement of mesh.

Lack Of Clinical Trials Prior To FDA Approval

Another factor that has contributed to the hundreds of pelvic mesh lawsuit claims is the manner in which the devices were approved for sale. Rather than being forced to undergo rigorous testing via clinical trials, they gained approval through the FDA’s 510(k) premarket notification process. Manufacturers such as Ethicon (a subsidiary of Johnson & Johnson) and C.R. Bard had only to prove their products were similar to those that were already approved. This is known as proving “substantial equivalence.”

The Wall Street Journal reported in September 2011 that the FDA was considering a reclassification of surgical mesh to the Class III high-risk category. This action comes on the heels of injuries and deaths stemming from complications with the product. The agency’s decision, however, does not excuse the manufacturers from responsibility for failing to ensure the public’s safety. To that end, many of the lawsuits that have been filed claim the manufacturers were negligent.

If you underwent surgery mesh placement for POP or SUI, and have suffered complications, you may be eligible for compensation for your injuries. Contact a transvaginal mesh lawsuit attorney to discuss your options and the latest vaginal mesh recall news.

In July 2011, the FDA released a safety communication that strongly cautioned the public about the problems associated with transvaginal mesh placement. Soon after, the first group of bladder sling lawsuit claims were filed against a small group of mesh manufacturers. It is useful to be familiar with the recent history of mesh complications, warnings from the FDA, and the lawsuits they motivated. We’ll cover this history below.

Pelvic Organ Prolapse And Stress Urinary Incontinence

Pelvic organ prolapse is a condition in which the muscles and ligaments supporting the bladder, rectum, small intestine, and uterus become stretched or weakened. This laxity causes one or more organs to fall from their positions, and bulge into the vagina. Symptoms depend on the type of prolapse (i.e. which organ has “fallen”) and its severity. The patient may encounter urinary problems, lower back pain, pelvic pressure, constipation, and pain during sex.

Stress urinary incontinence is caused by a weakening of the sphincter muscle and muscles of the pelvic floor. This allows an involuntary flow of urine triggered by pressure in the region. Such pressure may be caused by a sneeze, laugh, or cough. A urine leak can also be prompted by lifting heavy items and even sexual intercourse.

With POP, mesh is placed vaginally to help repair the wall of the vagina, and support the fallen (prolapsed) organs. With SUI, a bladder sling can be installed to support the urethra, applying pressure to prevent the involuntary loss of urine.

A Recent History Of Mesh Bladder Sling Complications

The public was first informed about problems stemming from vaginal placement of mesh for POP and SUI repair in 2008. Between 2005 and 2007, the FDA had received over 1,000 reports of device failures and other complications. Patients who had undergone vaginal placement reported experiencing vaginal pain and infection, erosion of the device through the vaginal wall, and problems related to urinary function. Some women also experienced scarring along the wall of the vagina. These details were disclosed in a public health notification issued by the FDA in October 2008. Complications were considered “rare.”

Between 2008 and 2010, the FDA received 2,874 additional reports of bladder sling complications. Most were associated with the repair of pelvic organ prolapse, though a large number stemmed from the repair of stress urinary incontinence. The same problems described in the agency’s previous announcement were present in these reports. The details were disclosed in the safety communication issued in July 2011. Complications were now considered to be “not rare.”

During this time, the August 2010 issue of Obstetrics & Gynecology published a study titled, “Vaginal Mesh for Prolapse: A Randomized Controlled Trial.” The researchers’ goal was to compare outcomes between traditional surgery and vaginal placement of mesh for POP repair. The clinical trial had to be abandoned before it could be completed. The women in the study suffered too many complications, including a 15.6% incidence rate of surgery mesh erosion.

On May 12, 2011, the New England Journal Of Medicine published a study titled, “Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse.” Colporrhaphy is a surgical procedure to repair the vaginal wall in cases of rectal and bladder prolapse. Researchers found a much higher likelihood of organ perforation during vaginal mesh surgery. Additionally, many of the women who underwent transvaginal placement required follow-up surgeries to address prolapse recurrence and mesh erosion.

In September 2011, the FDA convened a group of experts to discuss whether transvaginal mesh products should be reclassified as Class III medical devices. This classification is applied to devices that pose a risk high enough to warrant clinical trials.

Given the above history, it is unsurprising that hundreds of surgical mesh lawsuit claims have been filed. If you underwent transvaginal placement of pelvic mesh, and have suffered vaginal bleeding, infection, pain, and other side effects, you may be eligible to file a claim for compensation. Contact bladder sling lawsuit lawyer to discuss your case. Please contact us for the latest bladder sling recall and litigation news and updates.

The Food and Drug Administration has been aware of the problems caused by transvaginal placement of mesh for treating POP for years. They released a safety warning about the device in 2008, mentioning the agency had received over 1,000 reports of complications during the preceding three years. Today, the FDA is considering reclassifying surgical mesh to require that it undergo a more rigorous approval process. This has not stopped hundreds of women from filing vaginal mesh lawsuit claims, seeking compensation for their injuries.

FDA’s Position On Surgery Mesh Complications Changes

When the FDA released their initial safety warning on October 20, 2008, their position was cautionary, but reserved. They claimed that the complications stemming from transvaginal mesh placement for pelvic organ prolapse posed serious consequences, but were “rare.” The agency recommended that doctors seek special training for mesh placement and be watchful of potential side effects.

On July 13, 2011, the FDA’s original safety warning was updated with new language regarding the risks involved with vaginal placement of surgical mesh. It now stated that serious side effects stemming from the procedure were “not rare.” The update also notes that the number of adverse events reported to the agency following the original warning tripled.

There is also very little evidence that placing pelvic mesh transvaginally is safer or more effective than repairing pelvic organ prolapse via traditional methods. A review of scientific literature published between 1996 and 2011 revealed little proof that vaginal placement improved the patient’s “quality of life over traditional non-mesh repair.” The FDA repeated their recommendations to doctors, and encouraged them to seek other methods for repairing POP.

Possible Change To Transvaginal Mesh Classification

Due to the numerous complications that women have reported after undergoing vaginal mesh placement, the FDA is considering a broad reclassification for the device. In the past, the product was able to gain FDA approval through the agency’s controversial 510(k) premarket notification process. This process allows manufacturers to bring medical devices to market with very little testing. The requirement is that they must be able to prove their products are “substantially equivalent” to others that are already being legally marketed.

A lack of clinical trials increases the likelihood that a given medical device will cause complications. The FDA’s 510(k) approval process is thus widely-regarded as needing reform. Despite this, the agency notes in a September 2011 report regarding obstetrics and gynecology devices that they are not proposing a formal reclassification of pelvic mesh products. They are merely considering it as a way to improve the devices’ safety and effectiveness. Reclassifying these products as Class III medical devices would preclude them from the 510(k) approval process.

Side Effects Lead To Transvaginal Mesh Lawsuits

According to a September 8, 2011 article in BusinessWeek, Johnson & Johnson and C.R. Bard currently face nearly 500 pelvic mesh lawsuits. A few lawsuits are also being pursued against other manufacturers. Given that 75,000 women opt to have the device implanted transvaginally each year, this number is expected to grow.

Some lawsuits argue that the manufacturers of surgical mesh should have tested their devices more thoroughly before introducing them to an unsuspecting public. Other plaintiffs claim they were not properly informed by the manufacturers regarding the potential side effects caused by the devices.

While some surgery mesh complications can be resolved through surgery, many are virtually untreatable due to erosion of the device through the vaginal wall. Many women have been forced to endure vaginal infections, bleeding, pain during sexual intercourse, and other issues.

If you received a pelvic mesh implant and have suffered surgery mesh erosion or other side effects, you may be eligible for compensation for your injuries. Contact a transvaginal mesh lawsuit lawyer to discuss your options.