http://www.yourlawyer.com/topics/overview/mentor_obtape_vaginal_sling Sat, 21 Nov 2009 15:34:59 -0800 pixel-app en http://www.yourlawyer.com/articles/read/16528 Tue, 05 May 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16528 Mentor ObTape.  According to The New York Times, the device has become the subject of numerous lawsuits since Mentor Corporation removed it from the market in 2006.

The Mentor ObTape, used to treat stress urinary incontinence, is designed to replace eroded or weakened muscles in the urethra and is essentially a hammock for the vaginal wall. The vaginal sling technique has been around for about 100 years and is considered the “gold standard” in stress urinary incontinence treatment. Generally, the minimally invasive treatment can be done on an outpatient basis.

Almost as soon as the ObTape was introduced in 2003, patients who received it began to complain of serious complications. The most common of these injuries were vaginal erosions, basically the breakdown of the tissue that makes up the vaginal wall. This is an extremely painful condition that leads to chronic vaginal discharge and infection.  The design of the Mentor ObTape  also caused erosions of the urethra, and it allowed the device to cut into the vaginal wall, causing extreme and painful vaginal extrusions.

Mentor Corp., which was recently acquired by Johnson & Johnson, took the ObTape off the market in 2006.  However, according to The New York Times, to this day the company maintains that there is nothing wrong with the device.  

But earlier this year,  the Food & Drug Administration (FDA) warned that it had received thousands of reports of complications resulting from the use of devices like the Mentor ObTape. Treatment of the complications included IV therapy, blood transfusions, drainage of hematomas or abscesses, and additional surgical procedures, in some cases to remove the mesh, the agency said.

According to The New York Times, the Mentor ObTape was approved through the 510K process, which means it claimed that its product was so similar to ones already on the market it didn’t need complete testing.  A 510K approval - also known as "fast-track" approval - allows a device maker to avoid human clinical trials.

In this case, Mentor claimed the ObTape was similar to two other devices already on the market - Johnson & Johnson’s Tension Free Vaginal Tape System and American Medical Systems’ Sparc Sling System.  According to The New York Times, those devices also underwent 501K approval, based on the assertion that they were similar to Boston Scientific's Protegen sling.  Shockingly, the Protegen sling had been removed from the market in 1999 after the FDA classified it as an “adulterated and misbranded” product, the Times said.

Asked by the Times why it  would clear a product based on a recalled predecessor, the FDA  replied via email  that “Any legally marketed device can serve as a predicate for a premarket submission.”

As we've reported before, many patient advocates question the 501K approval process, and are seeking to have it reformed.  Earlier this year, a report by the Government Accountability Office (GAO) found that many older devices - including some that served as predecessor devices in 501K approvals - had never been proven safe and effective.  In April, the FDA responded to that report, and said it would be reviewing the safety of 25 types of devices not subject to rigorous testing in the past.

]]> http://www.yourlawyer.com/articles/read/15823 Fri, 09 Jan 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15823 Mentor ObTape Vaginal Sling, was withdrawn from the market in 2006 because of a high rate of serious complications.

According to the FDA, in the past three years, it has received over a thousand reports of complications. The most frequent included erosion of the mesh through the vaginal epithelium, infection, pain, urinary problems, and recurrence of the prolapse or the incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in quality of life due to discomfort and pain, including dyspareunia. Treatment of the complications included IV therapy, blood transfusions, drainage of hematomas or abscesses, and additional surgical procedures, in some cases to remove the mesh.

These types of complications are already all-too familiar to victims of the Mentor ObTape Vaginal Sling.  In 2006, the Journal of Urology published a study that examined an unusually high number of complications caused by Mentor ObTape. The study looked at  67 women who had been implanted with the Mentor ObTape Vaginal Sling, and found that more than 13 percent developed vaginal extrusions. Another eight developed a chronic vaginal discharge, and one patient developed an abscess of the left thigh that tracked to the incision site.

The poor design of the Mentor ObTape did not allow surrounding tissue to receive nutrients and oxygen, which impaired healing.  As a result, between 17 and 18 percent of the women who were implanted with a Mentor ObTape Vaginal Sling suffered from complications, with many forced to undergo a difficult surgical procedure to have the device removed. The problems associated with the Mentor ObTape Vaginal Sling were so severe and widespread that finally, in 2006 Mentor Inc. pulled it from the market.

The FDA has warned that clinicians using mesh for treatment of pelvic organ prolapse and stress urinary incontinence should:

• Obtain specialized training for each mesh placement technique, and be aware of its risks.
• Be vigilant for potential adverse events from the mesh, especially erosion and infection, and also from the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
• Inform patients about the potential for serious complications and their effect on quality of life, including scarring and pain during sexual intercourse. Patients should also be informed that implantation of surgical mesh is permanent, and that some complications associated with the mesh may require additional surgery that may or may not correct the problem.
• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if it is available.

]]> http://www.yourlawyer.com/articles/read/15370 Wed, 22 Oct 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/15370 Transvaginal placement of surgical mesh has caused serious complications, the Food & Drug Administration (FDA) warned yesterday.  According to the agency, treatment of these complications can be painful and require further surgery (some for mesh removal), intravenous therapy, blood transfusion, or hematoma/abscess drainage.  The FDA has advised that clinicians should receive specialized training for the transvaginal placement of mesh products and be vigilant for adverse events.

The transvaginal placement of surgical mesh is used to treat Stress Urinary Incontinence (SUI), an embarrassing loss of bladder control that afflicts 13 million people. The disorder occurs mostly in women, and is caused by weak muscle tone that can result from child birth, old age and other conditions.  

This procedure is also used to treat Pelvic Organ Prolapse (POP), a condition that occurs in women when the pelvic floor muscles become weak or damaged and can no longer support the pelvic organs. While POP is not considered a life threatening condition it may cause a great deal of discomfort and distress.

Problems with this treatment have been reported before.  In 2006, the Journal of Urology published a study that examined an unusually high number of complications caused by one type of surgical mesh, the Mentor ObTape Vaginal Sling. The study looked at  67 women who had been implanted with the Mentor ObTape Vaginal Sling, and found that more than 13 percent developed vaginal extrusions. Another eight developed a chronic vaginal discharge, and one patient developed an abscess of the left thigh that tracked to the incision site.

The poor design of the Mentor ObTape did not allow surrounding tissue to receive nutrients and oxygen, which impaired healing.  As a result, between 17 and 18 percent of the women who were implanted with a Mentor ObTape Vaginal Sling suffered from complications, with many forced to undergo a difficult surgical procedure to have the device removed. The problems associated with the Mentor ObTape Vaginal Sling were so severe and widespread that finally, in 2006 Mentor Inc. pulled it from the market.

Now the FDA is warning that the transvaginal placement of other surgical mesh products has caused similar problems.  According to the agency, during the last 3 years, 9 surgical mesh manufacturers have submitted more than 1000 reports of complications that have included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.  The FDA said that bowel, bladder, and blood vessel perforations have also been reported. In some cases, vaginal scarring and mesh erosion have led to significant discomfort and pain, significantly decreasing the patient's quality of life.

According to the FDA, specific characteristics of patients at increased risk for such complications have not been determined. The agency said that contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

To lessen the chances that the transvaginal placement of surgical mesh will result in complications, the FDA said physicians should:

• Obtain specialized training for each mesh placement technique, and be aware of its risks.
• Be vigilant for potential adverse events from the mesh, especially erosion and infection.
• Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
• Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
• Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

]]> http://www.yourlawyer.com/articles/read/14346 Tue, 06 May 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14346 Mentor’s ObTape Vaginal Sling is a medical device meant to stop the uncontrollable flow of urine as a result of urinary stress incontinence, a medical condition affecting about two million American women.  Patients with urinary stress incontinence are no longer able to control or stop urine flow, which often happens in the years following childbirth.  Approximately 35,000 women were implanted with Mentor Corporation’s ObTape and, now, women are reporting that the tape has deteriorated in their bodies and is making them ill and causing severe pain and other complications.

ObTape is a piece of mesh that is inserted as a type of sling that tapes up the bladder to prevent leaking. The Mentor ObTape Vaginal Sling is designed to replace eroded or weakened muscles in the urethra and is essentially a hammock for the vaginal wall.  The vaginal sling technique has been around for about 100 years and is considered the “gold standard” in stress urinary incontinence treatment.  Generally, the minimally invasive treatment can be done on an outpatient basis.

Meanwhile, one woman who has filed a lawsuit against Mentor Corporation, reports that following implantation of the mentor ObTape Vaginal Sling, the tape moved out of place and started to disintegrate inside her.  When she became ill, doctors removed the sling, piece by piece, which left her with a large leg wound.  Also, a medical study examined 67 patients and found that over 13 percent of patients experienced similar complications as well as impaired healing, vaginal extrusion, and urinary tract erosion that causes extreme vaginal pain, discharge, and infections, not to mention that the sling did not correct the original problem in many of the woman.   Another eight developed a chronic vaginal discharge and one patient developed an abscess of the left thigh that tracked to the incision site.  The study compared these patients to 56 others who had received another brand of vaginal sling.  None of those patients experienced the complications seen with the Mentor ObTape Vaginal Sling.

Some believe Mentor misled the Food & Drug Administration (FDA) when it applied for what's called 510K status, which means it claimed that its product was so similar to ones already on the market it didn't need complete testing.  Many believe the FDA was not as diligent as it should have been with the Mentor ObTape Sling.

Dr. Jaime Sepulveda is a national expert in pelvic floor medicine and reports he has always been skeptical about Mentor's ObTape because, unlike similar products on the market, it had different dimensions and hole sizes and it should have received separate Food and Drug Administration (FDA) approval.  The non-woven design of the Mentor ObTape Vaginal Sling blocked much-needed oxygen and nutrients while woven vaginal slings produced by other companies allow oxygen and nutrients to pass through.

Currently, there are a variety of lawsuits against the Mentor Corporation as more women come forward claiming that ObTape migrated inside their bodies, disintegrated, and required surgical removal.  Mentor no longer makes ObTape and within three years of the Mentor ObTape Vaginal Sling going on the market in 2003, the defective medical device was removed.

]]> http://www.yourlawyer.com/articles/read/13333 Thu, 15 Nov 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13333 Mentor ObTape Vaginal Sling has caused serious injuries to thousands of women.  Now, four  women who are suing the maker of the Mentor ObTape Vaginal Sling have come forward about the debilitating injuries this defective medical device causes, and how those injuries continue to negatively impact their lives.  

The Mentor ObTape Vaginal Sling was first marketed by Mentor Inc. in 2003. The device was meant to treat stress urinary incontinence, an embarrassing loss of bladder control that afflicts 13 million people. The disorder occurs mostly in women, and is caused by weak muscle tone that can result from child birth, old age and other conditions.  But almost as soon as it was introduced, patients who received the Mentor ObTape Vaginal Sling began to complain of serious complications. The most common of these injuries were vaginal erosions, basically the breakdown of the tissue that makes up the vaginal wall. This is an extremely painful condition that leads to chronic vaginal discharge and infection. The design of the Mentor ObTape Vaginal Sling also caused erosions of the urethra, and it allowed the device to cut into the vaginal wall, causing extreme and painful vaginal extrusions.

The defective Mentor ObTape Vaginal Sling has spawned lawsuits across the country.  Now, several women from Atlanta have sued Mentor over the injuries they suffered as a result of the Mentor ObTape Vaginal Sling.   Their suits claim that the mesh on the sling disintegrated, and some pieces became embedded in the vaginal wall or migrated to other parts of their bodies.   At a news conference last week, the women said that the Mentor ObTape Vaginal Sling caused them to suffer from chronic pain, infections, abscesses, bloody discharges and cellulitus.   One plaintiff said she was forced to undergo surgeries every other day over a three week period to allow doctors to remove infected tissue.   Another of the women described how she experienced a “blow out” of blood and other tissue from her upper thigh where pieces of the Mentor ObTape Vaginal Sling’s mesh had spread, causing an infection.  

The reason that the Mentor ObTape Vaginal caused such serious injuries was because of its poor design. Most of the other vaginal slings on the market are made with a woven, or mesh design. This allows surrounding tissue to receive nutrients and oxygen. The Mentor ObTape Vaginal Sling did not have this design, and this caused impaired healing. As a result, between 17 and 18 percent of the women who were implanted with a Mentor ObTape Vaginal Sling suffered from complications, with many forced to undergo a difficult surgical procedure to have the device removed. The Atlanta women, and thousands of others like them, thought the Mentor ObTape Vaginal Sling would be the answer to the embarrassing problem of urinary incontinence.  Instead, it ended up creating far more serious problems.

]]> http://www.yourlawyer.com/articles/read/13236 Mon, 22 Oct 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/13236 Mentor ObTape Vaginal Sling was removed from the market in 2006, just three years after being introduced.   The defective design of the Mentor ObTape Vaginal Sling made it far more prone to complications than other similar devices.  These complications often required patients to undergo multiple invasive surgeries, but even with competent medical care, the implantation of a Mentor ObTape Vaginal Sling often left patients with permanent serious injuries.  

The Mentor ObTape Vaginal Sling was first marketed by Mentor Inc. in 2003.   The device was meant to treat stress urinary incontinence, an embarrassing loss of bladder control that afflicts 13 million people.   The disorder occurs mostly in women, and is caused by weak muscle tone that can result from child birth, old age and other conditions.  There are a number of vaginal slings on the market, and they all work much the same way.  They basically act as a hammock to support the bladder and reinforce the muscles that control the flow of urine from the body.  The vaginal sling technique has been around for about 100 years, and is considered the “gold standard” in stress urinary incontinence treatment.   Generally, the minimally invasive treatment can be done on an outpatient basis.

But almost as soon as it was introduced, patients who received the Mentor ObTape Vaginal Sling began to complain of serious complications.  The most common of these injuries were vaginal erosions, basically the breakdown of the tissue that makes up the vaginal wall.  This is an extremely painful condition that leads to chronic vaginal discharge and infection.  The design of the Mentor ObTape Vaginal Sling also caused erosions of the urethra, and it allowed the device to cut into the vaginal wall, causing extreme and painful vaginal extrusions.

A study published in the October 2006 Journal of Urology discussed the widespread nature of the injuries caused by the Mentor ObTape Vaginal Sling. Of 67 women who had been implanted with the Mentor ObTape Vaginal Sling, more than 13 percent developed vaginal extrusions.   Another eight developed a chronic vaginal discharge, and one patient developed an abscess of the left thigh that tracked to the incision site.  The study compared these patients to 56 others who had received another brand of vaginal sling.  None of those patients experienced the complications seen with the Mentor ObTape Vaginal Sling.

The reason that the Mentor ObTape Vaginal Sling had such a high complication rate was because of its poor design.   Most of the other vaginal slings on the market are made with a woven, or mesh design.  This allows surrounding tissue to receive nutrients and oxygen.  The Mentor ObTape Vaginal Sling did not have this design, and this caused impaired healing.   As a result, between 17 and 18 percent of the women who were implanted with a Mentor ObTape Vaginal Sling suffered from complications, with many forced to undergo a difficult surgical procedure to have the device removed.   The problems associated with the Mentor ObTape Vaginal Sling were so severe and widespread that finally, in 2006 Mentor Inc. pulled it from the market.

But that did little to help the estimated 35,000 women who received the Mentor ObTape Vaginal Sling between 2003 and 2006.  Many of those women still suffer from serious crippling injuries caused by the device.   Unfortunately for them, the complications caused by the Mentor ObTape Vaginal Sling are often far worse the disorder it was supposed to fix.

]]> http://www.yourlawyer.com/topics/overview/mentor_obtape_vaginal_sling Mon, 22 Oct 2007 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/mentor_obtape_vaginal_sling Mentor ObTape Vaginal Sling The Mentor ObTape Vaginal Sling is a medical device manufactured to surgically treat female stress urinary incontinence.  Stress urinary incontinence affects about 13 million people, mostly women.  The embarrassing loss of bladder control caused by this condition can have a huge impact on a patient’s quality of life.

The Mentor ObTape Vaginal Sling transobturator device is an artificial structure that is designed to replace eroded or weakened muscles in the urethra. A vaginal sling is essentially a hammock for the vaginal wall, which is secured under the bladder to help support it.   The intention is to reinforce the muscles that control the flow of urine from the body.  The vaginal sling technique has been around for about 100 years, and is considered the “gold standard” in stress urinary incontinence treatment.   Generally, the minimally invasive treatment can be done on an outpatient basis.

But the Mentor ObTape Vaginal Sling did not work as intended.  Many women have had adverse reactions to the device including impaired healing, vaginal extrusion and urinary tract erosion that manifested itself in extreme vaginal pain, vaginal discharge, and infections.   The non woven design of the Mentor ObTape Vaginal Sling blocked much needed oxygen and nutrients while woven vaginal slings produced by other companies allow oxygen and nutrients to pass through.

ObTape Vaginal Sling Removed from Market
Not long after it was introduced, patients with the Mentor ObTape began to exhibit serious complications, including vaginal extrusion and urinary tract erosion, extreme vaginal pain, vaginal discharge, and infections.   A study published in the October 2006 Journal of Urology discussed the widespread nature of the injuries caused by the Mentor ObTape Vaginal Sling.  The study involved 67 women who had been implanted with the Mentor ObTape Vaginal Sling.  Of those, more than 13 percent developed vaginal extrusions.   Another eight developed a chronic vaginal discharge, and one patient developed an abscess of the left thigh that tracked to the incision site.  The study compared these patients to 56 others who had received another brand of vaginal sling.  None of those patients experienced the complications seen with the Mentor ObTape Vaginal Sling.

Within 3 years of the Mentor ObTape Vaginal Sling going on the market in 2003 the defective medical device was removed. The impact the OB Tape Vaginal Sling had on the lives of those women who were experienced complications was devastating as many experienced crippling pain and permanent scarring (vaginal erosion) damage from the procedures involved in the insertion and necessary removal of the device. The device failed to treat the female urinary stress incontinence in many women that it was implanted in. 

Mentor ObTape Vaginal Sling Lawsuit Lawyers
If you or a loved one has had the Mentor ObTape Vaginal Sling implanted and had complication you may be entitled to compensation.  Please contact our experienced defective medical device attorneys for a free Mentor ObTape Vaginal Sling lawsuit case review by calling 1-800-LAW-INFO or by filling out the form to the right.]]>