If you are experiencing problems because of mesh please consider
looking to our colleague, Linda Kilpatrick, for more information and support,
Bladder Sling Surgery Blog
See also: Mesh Medical Device News Desk
See also: Mesh Medical Device News Desk
I am
excited to report that I will be doing some follow up stories for an old
friend, Eric Chaffin, of Chaffin Luhana LLP about prolapse and
vaginal mesh complications. Eric is the one who originally approached me about
doing the below vaginal mesh series a couple of years ago
when he was with his old law firm. Eric, and his now law partner, Roopal
Luhana, have their own firm in NYC, Chaffin Luhana LLP. Eric and Roopal were
some of the first attorneys in the country to represent women in the Bard
Avaulta mesh litigation and in Gynecare
mesh lawsuits. They continue to represent women in these medical
device cases, as well as in other vaginal mesh litigations, including
representing women in cases against Boston Scientific and American Medical
Systems regarding allegedly defective vaginal mesh. You can learn more about
the vaginal mesh cases Chaffin Luhana is handling through the vaginal mesh
information website that Chaffin Luhana sponsors. I also hope that
you will visit us soon here at Natural Health News to read the
first of what I anticipate will be a multiple part follow up series regarding
vaginal mesh.
The
following list contains the major products and their manufacturers involved in
this industry. They are used in the surgeries, and are related to many of
the complications associated with these procedures. (Source: Chaffin Luhana)
Vaginal Mesh Devices Implicated
Johnson & Johnson®
·
Ethicon® TVT
·
Gynecare® TVT
·
Gynecare® Prosima
·
Gynecare® Prolift
·
Gynemesh® PS
Boston Scientific®
·
Advantage™ Sling System
·
Obtryx® Curved Single
·
Obtryx® Mesh Sling
·
Prefyx Mid U™ Mesh Sling System
·
Prefyx PPS™ System
·
Arise®
·
Pinnacle®
·
Lynx®
·
Solyx®
C.R. Bard®
·
Avaulta Plus™ BioSynthetic Support
·
Avaulta Solo™ Synthetic Support
·
Faslata® Allograft
·
Pelvicol® Tissue
·
PelviSoft® Biomesh
·
Pelvitex™ Polypropylene Mesh
American Medical Systems®
·
SPARC®
·
BioArc®
·
MiniArc®
·
Elevate®
·
Monarc®
·
Perigree®
·
In-Fast®
·
Apogee®
Informed Consent is a major factor in any surgical procedure. If you would like to get a copy of our newsletter on this topic, please make a donation on the main Natural Health News page and note 'IC' in the note when you order via PayPal.
UPDATE:
19 June, 2011
Several years ago I was commissioned by a consumer injury law
firm to write a series of articles. One of those articles, http://naturalhealthnews.blogspot.com/2009/03/transvaginal-mesh-and-womens-health.html addressed
issues with the transvaginal mesh device. This article is also found on
our other websites, simply4health.org and leaflady.org.
In the past several months I have noticed an increasing number
of TV ads for this device from consumer injury law firms. I have also
noticed a viral spread of this article which has booted the reader ship of my
blog, Natural Health News, by thousands of readers
daily.
This tells me that many women must be very interested in this
topic, either because they have had this surgery and are facing problems, or
they have been advised to have this operation.
Alternatives to the surgery are available options. I hope
to educate you about an important one that can do a great deal to prevent and
correct this condition.
Should you wish a copy of this new article please email us and
request it.
There are herbs and herbal combinations that can be used to help
with incontinence, pain, inflammation and other problems you may be
facing.
Please
consider a donation to Creating Health Institute via PayPal
and help us continue this important work.
You can also support this work by using Goodsearch search and shop for benefit of Creating Health Institute CHI.
We also offer other services, including our Health Forensics program, and products for your health and wellbeing.
As originally written in 2009, in cooperation with Eric Chaffin, this article has created an internet storm -
You can also support this work by using Goodsearch search and shop for benefit of Creating Health Institute CHI.
We also offer other services, including our Health Forensics program, and products for your health and wellbeing.
As originally written in 2009, in cooperation with Eric Chaffin, this article has created an internet storm -
Transvaginal Surgical Mesh Origins
Polypropylene was first developed in the 1950s as a thermoplastic polymer resin of propylene and is made from petroleum. Polypropylene may be molded or extruded into many forms, including fibers for suture material, specially produced mesh and nonwoven sheet applications. Nonwoven polypropylene fabric later began to be extruded from polymer melts rather than from fibers.
Quaternary ammonium biocides are used as a disinfectant and germ killing substance because they disrupt the cell membrane and proteins. QUATS may not, however, be fully effective against Pseudomonas bacteria. Also, researchers have found in laboratory experiments that oleamide, which interacts with neurotransmitters, may leak out of polypropylene plastics.
Polypropylene Knitted Mesh (PPKM) fabrics are comprised of monofilament yarns, which are engineered for the manufacturing of textile fabrics. The polymer and manufacturing processes that are used produce fabrics with properties that are ideally suited for the manufacturing of medical device applications. Medical applications include hernia mesh patches, stress urinary incontinence (SUI) slings, and vaginal prolapse suspenders.
Nonwoven polypropylene fabric has been used for similar applications.
Problems with polypropylene fabrics have led to warnings being issued for various products made from nonwoven material and in some cases, the manufacturers have stopped marketing the products
According to adverse reports submitted to the FDA from nine different manufacturers, more than 1,000 people have suffered severe complications from surgical mesh implants. The reports include infection, pain, urinary problems and bowel, bladder or blood-vessel perforations. The repaired prolapse may have recurred or incontinence increased. Additional surgeries to remove mesh have been required because of vaginal erosion.
Transvaginal Surgical Mesh to Treat SUI
Sudden Urinary Incontinence (SUI) is estimated to affect as many as 11 million women in the United States. It is generally defined as the sudden, involuntary loss of urine when a patient is laughing, sneezing, coughing or exercising. SUI is caused by anything that may have led to serious pelvic muscle strain or weakness such as vaginal childbirth. It can be exacerbated by estrogen and other hormonal imbalance accompanying menopause.
Nearly 40% of all adult American women will experience various degrees of SUI during their lifetime. Symptoms can range from occasional leakage of a few drops of urine to complete loss of urine under certain conditions of stress. Although nonsurgical methods such as dietary changes, bladder retraining, Kegel exercises, biofeedback, pessaries, electrostimulation, and drug therapies have been used successfully to treat these women, many patients eventually require surgical repair to relieve their symptoms.
Historically, and for many decades, the Kelley plication or the Marshall-Marchetti (Krantz) procedures have been the main hospital based surgical treatments for reinforcing the bladder neck in order to prevent unintentional urine loss.
Other surgical techniques have been used to correct pelvic organ prolapse (POP), a related condition.
Transvaginal Surgical Mesh to Treat POP
The problem of incontinence for women from various causes becomes more common after pregnancy and in menopause, when surgery can be recommended after other non-intrusive treatments are not found effective.
These conditions are referred to as Pelvic Organ Prolapse(POP).
POP is the term that describes a condition when a pelvic organ drops from its normal location and pushes against the walls of the vagina. This generally occurs when muscles that hold pelvic organs in place are weakened or stretched by childbirth or surgery. POP can lead to symptoms that include pain, discomfort, loss of bladder control and constipation.
Mentor Sling
One popular product, known as the transobturator vaginal sling, was made by Mentor Corporation. This product was more commonly called “OB Tape.”
Mentor manufactured an OB Tape vaginal sling that was not recalled, but the company stopped marketing it in the spring of 2006. The product used a nonwoven material which made it different in design than most other mesh devices. The nonwoven fabric is alleged to have blocked oxygen and nutrients, substantially increasing the risk of problems such as infection. This impedance potentially can cause serious problems with the device that may not appear for months, or even years following implantation surgery.
The complication rate could very easily reach 20% of all patients who used the Mentor sling.
At least 35,000 women may have been treated with the OB Tape vaginal sling between 2003 and 2006 to treat female stress urinary incontinence (SUI). The bladder sling is designed to prevent involuntary leakage that occurs when pelvic muscles supporting the bladder and urethra are stressed or weakened. A number of women have filed Mentor sling lawsuits.
A study published in the Journal of Urology in October 2006 highlighted the risk of complications associated with the OB Tape sling. More than 13% of the women who received the Mentor Sling for incontinence allegedly have suffered vaginal extrusions. Many more cases reported women who suffered chronic vaginal discharge and abscesses.
Symptoms of OB Tape Sling injury may include but are not be limited to:
· High fever
· Vaginal Pain
· Pelvic Pain
· Pain During Sex
· Chronic Infections
· Perineal Cellulitis
· Severe Pain in the Back, Hips and Legs
If you have had this surgery and are experiencing any of these or other symptoms not listed here, immediately contact your health care provider.
If you have suffered an injury or Mentor sling side effects from surgery involving the use of a Mentor sling, and would like to learn about your legal rights and pursuing a Mentor sling lawsuit, you can find information at Consumer Injury Lawyers.
Other Transvaginal Surgical Meshes
Another product, Gynecare’s Prolift Sling, created serious problems that required additional surgery that has caused permanent injury. The Avaulta Bard surgical mesh, which is used to treat POP and SUI have also been the subject of Avaulta transvaginal mesh lawsuits. It has led some consumer advocates to call for an Avaulta transvaginal mesh recall.
If you have had a prolene mesh pelvic floor repair system and have suffered complications, you may have a viable product liability claim. In October 2008 the FDA transvaginal mesh alertwas issued for at least nine manufacturers of vaginal sling products.
Overall use of these surgical mesh products has been associated with severe and debilitating injuries including vaginal extrusions, urinary tract erosions, infection and nerve pain. Other known complications include, but are not limited to, mesh erosion, mesh shrinkage, granuloma from tissue injury or dyspareunia (pain with sexual relations).
Product and procedure failure with the tape sling products have required additional surgeries to remove the mesh, along with an increased risk of more injury.
If you have suffered an injury from any surgery involving the use of the surgical meshes referred to in the above article and would like to learn about your legal rights, you can find information from Consumer Injury Lawyers, a consumer advocacy legal website that provides helpful information to consumers about various drugs and medical devices, including for example information about the recent reports of zinc poisoning caused by denture cream, including information about denture cream lawsuits such as how to file a Fixodent lawsuit orPoligrip lawsuit.
This article is part of a consumer health education series written by Gayle Eversole, DHom, PhD, MH, NP, ND, of Creating Health Institute, in collaboration with Bernstein Liebhard, LLP.
The views expressed in this article are solely those of the author, Gayle Eversole.
Subsequent articles about transvaginal mesh since my original article was published in 2009 -
Related article 2011
Polypropylene was first developed in the 1950s as a thermoplastic polymer resin of propylene and is made from petroleum. Polypropylene may be molded or extruded into many forms, including fibers for suture material, specially produced mesh and nonwoven sheet applications. Nonwoven polypropylene fabric later began to be extruded from polymer melts rather than from fibers.
Quaternary ammonium biocides are used as a disinfectant and germ killing substance because they disrupt the cell membrane and proteins. QUATS may not, however, be fully effective against Pseudomonas bacteria. Also, researchers have found in laboratory experiments that oleamide, which interacts with neurotransmitters, may leak out of polypropylene plastics.
Polypropylene Knitted Mesh (PPKM) fabrics are comprised of monofilament yarns, which are engineered for the manufacturing of textile fabrics. The polymer and manufacturing processes that are used produce fabrics with properties that are ideally suited for the manufacturing of medical device applications. Medical applications include hernia mesh patches, stress urinary incontinence (SUI) slings, and vaginal prolapse suspenders.
Nonwoven polypropylene fabric has been used for similar applications.
Problems with polypropylene fabrics have led to warnings being issued for various products made from nonwoven material and in some cases, the manufacturers have stopped marketing the products
According to adverse reports submitted to the FDA from nine different manufacturers, more than 1,000 people have suffered severe complications from surgical mesh implants. The reports include infection, pain, urinary problems and bowel, bladder or blood-vessel perforations. The repaired prolapse may have recurred or incontinence increased. Additional surgeries to remove mesh have been required because of vaginal erosion.
Transvaginal Surgical Mesh to Treat SUI
Sudden Urinary Incontinence (SUI) is estimated to affect as many as 11 million women in the United States. It is generally defined as the sudden, involuntary loss of urine when a patient is laughing, sneezing, coughing or exercising. SUI is caused by anything that may have led to serious pelvic muscle strain or weakness such as vaginal childbirth. It can be exacerbated by estrogen and other hormonal imbalance accompanying menopause.
Nearly 40% of all adult American women will experience various degrees of SUI during their lifetime. Symptoms can range from occasional leakage of a few drops of urine to complete loss of urine under certain conditions of stress. Although nonsurgical methods such as dietary changes, bladder retraining, Kegel exercises, biofeedback, pessaries, electrostimulation, and drug therapies have been used successfully to treat these women, many patients eventually require surgical repair to relieve their symptoms.
Historically, and for many decades, the Kelley plication or the Marshall-Marchetti (Krantz) procedures have been the main hospital based surgical treatments for reinforcing the bladder neck in order to prevent unintentional urine loss.
Other surgical techniques have been used to correct pelvic organ prolapse (POP), a related condition.
Transvaginal Surgical Mesh to Treat POP
The problem of incontinence for women from various causes becomes more common after pregnancy and in menopause, when surgery can be recommended after other non-intrusive treatments are not found effective.
These conditions are referred to as Pelvic Organ Prolapse(POP).
POP is the term that describes a condition when a pelvic organ drops from its normal location and pushes against the walls of the vagina. This generally occurs when muscles that hold pelvic organs in place are weakened or stretched by childbirth or surgery. POP can lead to symptoms that include pain, discomfort, loss of bladder control and constipation.
Mentor Sling
One popular product, known as the transobturator vaginal sling, was made by Mentor Corporation. This product was more commonly called “OB Tape.”
Mentor manufactured an OB Tape vaginal sling that was not recalled, but the company stopped marketing it in the spring of 2006. The product used a nonwoven material which made it different in design than most other mesh devices. The nonwoven fabric is alleged to have blocked oxygen and nutrients, substantially increasing the risk of problems such as infection. This impedance potentially can cause serious problems with the device that may not appear for months, or even years following implantation surgery.
The complication rate could very easily reach 20% of all patients who used the Mentor sling.
At least 35,000 women may have been treated with the OB Tape vaginal sling between 2003 and 2006 to treat female stress urinary incontinence (SUI). The bladder sling is designed to prevent involuntary leakage that occurs when pelvic muscles supporting the bladder and urethra are stressed or weakened. A number of women have filed Mentor sling lawsuits.
A study published in the Journal of Urology in October 2006 highlighted the risk of complications associated with the OB Tape sling. More than 13% of the women who received the Mentor Sling for incontinence allegedly have suffered vaginal extrusions. Many more cases reported women who suffered chronic vaginal discharge and abscesses.
Symptoms of OB Tape Sling injury may include but are not be limited to:
· High fever
· Vaginal Pain
· Pelvic Pain
· Pain During Sex
· Chronic Infections
· Perineal Cellulitis
· Severe Pain in the Back, Hips and Legs
If you have had this surgery and are experiencing any of these or other symptoms not listed here, immediately contact your health care provider.
If you have suffered an injury or Mentor sling side effects from surgery involving the use of a Mentor sling, and would like to learn about your legal rights and pursuing a Mentor sling lawsuit, you can find information at Consumer Injury Lawyers.
Other Transvaginal Surgical Meshes
Another product, Gynecare’s Prolift Sling, created serious problems that required additional surgery that has caused permanent injury. The Avaulta Bard surgical mesh, which is used to treat POP and SUI have also been the subject of Avaulta transvaginal mesh lawsuits. It has led some consumer advocates to call for an Avaulta transvaginal mesh recall.
If you have had a prolene mesh pelvic floor repair system and have suffered complications, you may have a viable product liability claim. In October 2008 the FDA transvaginal mesh alertwas issued for at least nine manufacturers of vaginal sling products.
Overall use of these surgical mesh products has been associated with severe and debilitating injuries including vaginal extrusions, urinary tract erosions, infection and nerve pain. Other known complications include, but are not limited to, mesh erosion, mesh shrinkage, granuloma from tissue injury or dyspareunia (pain with sexual relations).
Product and procedure failure with the tape sling products have required additional surgeries to remove the mesh, along with an increased risk of more injury.
If you have suffered an injury from any surgery involving the use of the surgical meshes referred to in the above article and would like to learn about your legal rights, you can find information from Consumer Injury Lawyers, a consumer advocacy legal website that provides helpful information to consumers about various drugs and medical devices, including for example information about the recent reports of zinc poisoning caused by denture cream, including information about denture cream lawsuits such as how to file a Fixodent lawsuit orPoligrip lawsuit.
This article is part of a consumer health education series written by Gayle Eversole, DHom, PhD, MH, NP, ND, of Creating Health Institute, in collaboration with Bernstein Liebhard, LLP.
The views expressed in this article are solely those of the author, Gayle Eversole.
Subsequent articles about transvaginal mesh since my original article was published in 2009 -
Related article 2011
Mesh is riskier but higher success rates for treating pelvic organ
prolapse
Friday, 13 May 2011-
For women with pelvic-organ prolapse, a transvaginal mesh kit
improves treatment success rates compared with traditional colporrhaphy.
However, the treatment comes at a cost of more surgical complications and
adverse events, according to a randomised trial in Scandinavia.
Women treated with the mesh kit were more likely to be free of
prolapse a year later as defined by both objective and subjective measures
(60.8% versus 34.5%, P<0.001), said Dr. Daniel Altman of Danderyd Hospital
in Stockholm, and colleagues.
But adverse events were more frequent in the mesh group both in
the hospital and during follow-up, the researchers reported in the May 12 issue
of the New England Journal of Medicine.
"When one is counselling patients regarding surgical options,
the benefits of the mesh kit must be balanced against the higher rates of
surgical complications and postoperative adverse events associated with this
approach," the authors concluded.
Although the most common operation for pelvic-organ prolapse is
anterior colporrhaphy for prolapse of the anterior vaginal wall, the use of
standardised mesh kits has rapidly grown in popularity, despite the lack of
evidence that the approach is better than traditional surgery.
"Our results highlight the need for a careful evaluation of
surgical innovations, which are often widely adopted in the absence of data
from clinical trials," Altman and his colleagues wrote.
At 53 centres in Sweden, Norway, Finland, and Denmark, the
researchers compared repair with a transvaginal polypropylene-mesh kit (200
patients) with traditional colporrhaphy (189 patients) in women with prolapse
of the anterior vaginal wall.
Mean age of the patients was 65.1 in the colporrhaphy group and
64.3 in the mesh group.
The mesh kit used was the Gynecare Prolift Anterior Pelvic Floor
Repair System kit.
The primary outcome was a composite of an objective determination
of the lack of prolapse indicated by stage 0 or 1 according to the Pelvic Organ
Prolapse Quantification system and a subjective report of the absence of
vaginal bulging 12 months after the surgery.
At that one-year mark, women treated with the mesh kit were more
likely to be free of prolapse (OR 3.6, 95% CI 2.2 to 5.9). Both components of
the primary endpoint favored the mesh group, as well.
However, surgery took longer for those in the mesh group (52.6
versus 33.5 minutes). They also had greater mean intraoperative blood loss
(84.7 mL versus 35.4 mL), and more frequent need for intraoperative cystoscopy.
All differences were significant at P<0.05.
Those findings were "consistent with the more invasive nature
of this procedure as compared with colporrhaphy," according to the
authors.
The mesh group also had higher rates of bladder perforation (3.5%
versus 0.5%) and of usually or always having pain during sexual intercourse
(7.3% versus 2%), although neither difference reached statistical significance
(P=0.07 for both).
Inguinal pain and bladder-emptying difficulties were more common
during the hospital stay for patients who underwent mesh repair, as was new
stress urinary incontinence during follow-up (12.3% versus 6.2%, P=0.05).
Vaginal wound revision was required by 3.2% of the patients in the
mesh group, which "is higher than the complication rates reported after
the use of midurethral sling procedures for incontinence but lower than in
another study of the use of transvaginal mesh for prolapse surgery,"
according to Altman and his colleagues.
There were two deaths -- one in each group -- but both were
related to cardiovascular disease.
Source: D. Altman, et al., "Anterior colporrhaphy versus
transvaginal mesh for pelvic-organ prolapse,"New England Journal of
Medicine 2011; 364: 1826-1836.
UPDATE: 13 July
By Kristina Fiore, Staff Writer, MedPage Today, July 13,
2011
FDA
Beefs Up Transvaginal Mesh Warning
Transvaginal
placement of surgical mesh to treat pelvic organ prolapse may carry more risks
than other surgical options, without any evidence of greater benefit, the FDA
said.
The
agency warned that mesh placed transvaginally was associated with adverse
events including erosion through the vaginal tissue, pain, infection, bleeding,
pain during intercourse, organ perforation from surgical tools used in the
placement procedure, and urinary problems
Some
reports cited the need for additional surgeries or hospitalization to treat
complications or remove the mesh, the agency said.
The
number of adverse events linked to the device has been increasing in recent
years. About 1,500 reports were filed between 2008 and 2010 -- five times as
many as in 2005 to 2007, according to the FDA.
The
agency first issued a safety communication on the product in 2008.
"The
FDA is asking surgeons to carefully consider all other treatment options and to
make sure that their patients are fully informed of potential complications
from surgical mesh," William Maisel, MD, MPH, deputy director of FDA's
center for devices and radiological health, said in a statement. "Mesh is
a permanent implant -- complete removal may not be possible and may not result
in complete resolution of complications."
In its
review of the literature from 1996 to 2010, the FDA found that patients who
have transvaginal pelvic organ prolapse repair with mesh are exposed to
additional risks compared with those who have repair with stitches alone.
They found
that while the mesh often corrected the anatomy, there was no evidence of
greater clinical benefit than non-mesh surgery.
In
2010, there were at least 100,000 pelvic organ prolapse repairs with surgical
mesh. About 75,000 of these were transvaginal procedures, the FDA said.
The
agency said that doctors should recognize that, in most cases, pelvic organ
prolapse can be treated without mesh.
It also
warned clinicians that mesh implants are permanent, and future repairs may
challenging, putting patients at risk for additional complications and
surgeries.
The FDA
emphasized that the current warning does not apply to mesh placed abdominally,
or to treatment for stress urinary incontinence. In September, an FDA advisory
committee will meet to discuss the safety and efficacy of the mesh products in
those indications.
UPDATE: 17 August, from the UK D. Mail
16.8.11
"INCONTINENCE
OP THAT'S RUINING WOMEN'S LIVES"
by Lois Rogers.
1000s of women have been left severely damaged by an
implantable 'sling' operation to treat problems following childbirth.
The NHS faces a crisis on a par with the
compensation claims for leaking silicone breast implants in the 1990s. Up
to 40,000 women in UK are believed to have received an implantable plastic
mesh called trans-vaginal tape (TVT) which is intended to support the
pelvic organs to prevent incontinence. But in an estimated 10% of cases
the mesh disintegrates within months. The tiny fragments, measuring only a
few millimetres, migrate & become embedded elsewhere in the body,
triggering infection & inflammation. Women can be left in intractable
pain. Despite some women undergoing 10 or more operations to remove the
mesh, surgeons say it is impossible to get it out completely. As a result,
the sling procedures is no longer recommended in USA as the FDA say it
exposes women to risk.
Resources for FDA UPDATES
Public Health Updates on MESH
Alerts and Notices
Device Recalls
