Surgical Mesh: The Ten Year Window

The Ten Year Window

 

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

Mesh Medical Device News Desk

I have spent many years in the health care industry. The outcome of the observations I have made tells me that most often it takes about 10 years for facts to catch up with drug, treatments, and device approvals.

Approvals in this arena come from the Food and Drug Administration (FDA). Commonly, because of the faster fast track system instituted now for a couple of decades, money buys the ticket to the train. When first instituted Fast Track cost a manufacturer about $330,000; now it is at least double.

This doesn’t end up doing too much for safety because, if you follow the news, you too frequently hear about a drug recall, an ineffective treatment, or medical device failures along with product liability law suits.

Surgical mesh offers no different scenario.

The FDA orders Johnson & Johnson, C.R. Bard and 31 other companies to take another look at complication rates associated with their transvaginal mesh implants.

Retropubic urethral suspension was first used in 1910. Since that time over 100 different surgical techniques for the treatment of genuine stress urinary incontinence (GSUI) have been described.

Procedures done through the abdomen have been referred to as "bladder lifts". These include procedures known as the Burch repair and Marshall-Marchetti (1949) procedure. Although these are very "old" surgical procedures, the results have proven durable over time.

Some surgeons believe that the sling surgery should be used only in certain special cases because of its higher rate of complications and because they have found the older surgery techniques to be effective.

Pubovaginal Sling Procedures 

In instances where mesh may be contraindicated the procedures can be done with natural products such as bovine, or cadaver grafts.

Your physician should discuss all options with you for your situation to help you to decide which procedure is the correct one for you.

In the early 1990s, at the time use of surgical mesh began becoming popular there were no long term studies available on the differing types of products, and few long term studies of the surgical techniques.

Vaginal mesh repair has become popular, because of access to the areas involved in surgery, ease of application using the manufacturers' needles, variable mesh sizes that can be cut to size during surgery, laparotomy is not required, the option of achieving permanent tissue replacement after failure of tissue reconstruction, and experience with similar materials.

According to Dr. Saralyn Mark, a spokesperson for COOK in the capacity of Senior Scientific Policy Advisor, surgical mesh has been used for over a decade. COOK has provided biologically-derived grafts that are not cross-linked, including grafts for pelvic organ prolapse, for about 13 years. Dr. Mark’s statement was part of her presentation in September 2011 at the FDA conference covering the problems with this product.

There are several types of mesh or similar products and they are most often used in surgery involving hernia, uterine prolapse, bladder prolapse, rectocele, cystocele, and other applications.

Synthetic mesh is found in absorbable and non-absorbable forms. Biologically derived graft material is offered in cross-linked and non-crosslinked forms.

The type of material selected and the outcome of surgery is, according to Marks, best determined by “(1) assuring that the patient is a suitable candidate, (2) performing the procedure correctly, and (3) choosing the appropriate product”.

Based on the three criteria, Marks went on to state that she reviewed numerous articles where the studies referenced one of the four types of material for implant.

COOK’s findings show that most non-absorbable synthetic mesh is made of Type I polypropylene. Outcomes for this type material suggest that there is a strong bond with mesh and surrounding tissue encapsulation. In some cases the long term tissue response is more like a foreign body reactions that may include granulation tissue, limited neovascularization, eventual fibrosis, and encapsulation.

Foreign body reactions are similar to transplant surgeries where anti-rejection drugs are commonly prescribed in an effort to reduce risk of rejection.

Absorbable synthetic mesh can rapidly degrade and does not provide long term tissue support. For this reason this type of product is rarely used.

Cross-linked biologic grafts are made with chemical agents to bond or “cross-link” collagen fibers together in an effort to reduce degradation. The material seems not to support normal movement of body cells into the graft is significantly. Because of this inflammation occurs and over time leads to a foreign body reaction and encapsulation. The tissue response of chemically cross-linked graft material has been found to be very similar to the synthetic products.

Non-crosslinked biologic grafts are minimally processed to remove cells and leave no cross-linked collagen.

They offer both mechanical strength and a platform to promote “cellular infiltration, proliferation, and remodeling of the patient’s tissue”. Long term outcome with this type product aids repair and reinforcement as the graft is replaced by connective tissue and normal blood supply.

Review of 15 years of reports using different types of graft material evaluated these studies for incidence of “(1) erosion, (2) pain including dyspareunia, (3) graft-related infection, (4) persistence or recurrence of prolapse based on objective measures (such as the POP-Q score), and (5) symptomatic recurrence.”

Of these five parameters the final evaluation specifically looked at three objective measures for each type of material: (1) erosion, (2) infection, and (3) objective measurement of recurrence. Pain and other symptomatic complaints were excluded.

Overall findings with non-absorbable synthetic mesh products had a 10% erosion rate, while crosslinked biologics had 6.2% rate. Repairs with non-crosslinked biologic grafts had the lowest erosion rate at 1.2%.

Infection rates associated with material types were approximately 4.0%.

Of course and of great concern to patients are pain and other complaints, including but not limited to forced lifestyle change and quality of life concerns.

There is great consideration given to the need for follow-up sonography to evaluate the anterior and posterior mesh positions after prolapse surgery. Reported frequently is a considerable discrepancy between the implanted mesh size and its length measured after six weeks by postoperative ultrasound.

In consideration of economic cost, the recently reported direct cost of pelvic organ prolapse surgeries were between $1012 million and $1251 million dollars. Of this $494 million (49%) covered costs for vaginal hysterectomy; $279 million (28%) were costs for both cystocele and rectocele repair; and $135 million dollars (13%) were allocated for abdominal hysterectomy.

Physician services accounted for 29% ($298 million) of total costs, and hospitalization accounted for 71% ($714 million). Twenty-one percent of all reported pelvic organ prolapse operations included urinary incontinence procedures ($218 million). If all of the reported surgeries were reimbursed by non-Medicare sources, the annual estimated cost would increase by 52% to $1543 million.

Procedures using surgical mesh are permanent. There may be benefit in first understanding long term complications as these may include mesh erosion into the vagina, bladder or rectum; painful intercourse; infection or bleeding.

The FDA has received thousands of complaints about surgical mesh. Examples follow of manufacturer and complaints filed as of 2009 -

Manufacturer Product names and Number of MAUDE* reports

American Medical Systems SPARC 65

Bard Pelvicol, Pelvisoft 64, 1

Boston Scientific Scimed Prefyx PPS, Obtryx Curved Single, Obtryx Mesh Sling, Advantage Sling System, Prefyx System Mid U, Mesh Sling System23, 1, 62, 29, 23, 78

Caldera T-Sling 2

Ethicon Gynemesh PS (K013718) a/k/a/ Prolift Pelvic Floor, Prolene Polypropylene Mesh 123, 72

Gynecare Secur, Tension Free Vaginal Tape 1, 4

Johnson & Johnson – Switzerland K974098 495

Mentor ObTape (K031767) 236

Sofradim Uretex TO, Avaulta Biosynthetic, Uretex Pubovaginal Sling/support kit, Bard Posterior Biosynthetic Support System, Pelvetex Polypropylene Mesh 64, 0, 27, 3, 0

*MAUDE (Manufacturer and User Facility Device Experience) data represents reports of adverse events involving medical devices received by the FDA.

Cases involving Kugel Mesh Hernia Patches involving hernia repair are also on the increase. Davol, Inc., a division of the C. R. Bard, Inc., in December 2005 issued a recall following reports that the patch memory recoil ring may not withstand stresses associated with specific surgical placement techniques. The recall extended into 2006 and a law suit was filed against this product in December 2006.

Expanded recalls into 2007 were related to memory recoil ring breaks that had caused bowel perforation, bowel obstruction, internal pain, internal fistulas, migration through the abdominal wall, and additional surgery for repair or removal of mesh, blood clots, and death caused by septic shock. A case of acute heart attack secondary to surgery for bowel fistula repair was caused by perforation from the broken memory recoil ring.

Infertility has been reported secondary to a fibrotic reaction to mesh used in surgery for repair of inguinal hernia.

Some studies report that there can be a systemic allergic reaction to polypropylene mesh used in surgical treatment. These studies found too that Polytetrafluoroethylene (PTFE - fluoride) coated mesh, DuPont’s synthetic fluoropolymer of tetrafluoroethylene, may cause a greater risk.

Many researchers determined that skin patch tests should be conducted on patients in a timely manner before undergoing any surgery using polypropylene materials.

Davol and Bard were later involved in an FDA criminal investigation related to the sale of counterfeit surgical mesh kits containing flat sheets of polypropylene.

Between 2002 and 2006 Davol sold approximately 32,000 kits worldwide. In 2005 mesh kit sales generated $11 million for this firm.

In September 2011 the FDA called for the Obstetrics & Gynecology Devices Advisory Committee to discuss the issues related to the use of surgical mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The panel discussed the use of surgical mesh and its risks and benefits based on the literature and adverse reporting data (MAUDE).

Comments were taken about proposed FDA premarket and post market regulatory strategies for surgical mesh use in POP and SUI, and reclassification from Class II into Class III.

The goal of the panel is to assist FDA in determining whether there is need for additional clinical studies (premarket and/or post market) on surgical mesh use, based on data from the published literature and the MAUDE database. 

Perhaps as we move in to the future more careful consideration will be given to evaluation based on other than journal articles and adverse reporting data.

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 Chaffin Luhana LLP

The views expressed in this article are solely those of the author, Gayle Eversole.

Transvaginal Mesh 1

http://naturalhealthnews.blogspot.com/2011/10/fda-slow-to-take-action-on-vaginal-mesh.html

http://naturalhealthnews.blogspot.com/2009/03/transvaginal-mesh-and-womens-health.html

http://naturalhealthnews.blogspot.com/p/womens-health-transvaginal-mesh.html

http://leaflady.org/mesh2.htm

Read More

FDA slow to take action on vaginal mesh

UPDATE: 24 January 2012

 

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

Mesh Medical Device News Desk

Dems call for Lap-Band, mesh probes ahead of MDUFMA re-authorization

Democrats in the U.S. House of Representatives are calling for a congressional probe into a pair of high-profile medical device products – Lap-Bands and vaginal mesh – as Congress gears up for hearings and a vote on re-authorizing the Medical Device User Fee & Modernization Act.

Democrats in the U.S. House, concerned about a pair of high-profile medical devices, want the Energy & Commerce Committee to open a probe into gastric band and vaginal mesh products. SOURCE

US House of Representatives recently has been visiting my series of articles on surgical mesh.  Find them all using our search window.

5 January 2012

FDA wants new studies on surgical mesh

By Anna Yukhananov,  Thu Jan 5, 2012

WASHINGTON (Reuters) - U.S. health regulators ordered new safety studies for surgical mesh implants that are used to hold pelvic organs in place, citing a spike in the number of complications seen for female patients, including erosion and infection.The Food and Drug Administration also said it may reclassify the devices in a higher-risk category that would require manufacturers, such as Boston Scientific and a unit of Johnson & Johnson, to conduct clinical trials in people before receiving approval for sale.
The companies could not be immediately reached for comment.
The devices, made of synthetic or biological material, are commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse (POP). They are also used to help those with a severe overactive bladder known as stress urinary incontinence.
The FDA said it received more than 1,500 reports of complications related to the repairs with mesh from 2008 to 2010, including cases in which the mesh eroded into the vagina or caused bleeding and infection. The rate of problems was five times the rate reported from 2005 to 2007.
The FDA sent letters this week to 35 manufacturers of transvaginal surgical mesh, requesting three-year studies of several hundred women each to study side effects, as well as the women's overall quality of life.
In July, the agency warned that complications with the mesh were "not rare" and that transvaginal organ repair using mesh may put patients at greater risk than other surgeries and treatments.
The FDA also said it was concerned about scientific studies that show a lack of clinical benefit from surgical mesh, compared to non-mesh repair.
About 75,000 women received mesh repairs for pelvic organ prolapse in 2010 and about 200,000 women received transvaginal repairs for stress urinary incontinence.
The agency is asking for more studies from companies that sell the mesh for POP surgery. In the case of mesh used to correct an overactive bladder, the FDA is seeking further study of use of a so-called "mini-sling," when strips of material are used around the bladder neck and the urethra.
During their lifetime, 30 percent to 50 percent of women may experience POP, with two percent developing symptoms. The condition happens when tissue that holds the pelvic organs in place becomes weak or stretched and bulges into the vagina.
Surgery to support prolapsing organs can be done through the abdomen or the vagina, either with stitches or also with surgical mesh for reinforcement.
Surgical mesh has been used since the 1950s to repair abdominal hernias, but doctors only started using the mesh for POP and stress urinary incontinence in the 1990s, a procedure that has grown in popularity.
Companies that wanted to make the mesh specifically for POP or urinary incontinence could submit their application under a 510(k) accelerated review application that did not require them to do clinical trials in people, as long as they could show their implants were similar to devices already on the market.
But during a panel meeting in September, outside advisers to the FDA recommended that the agency reclassify the devices for POP to require companies to submit additional studies. The FDA said it is considering their advice.
Jeffrey Grand, a lawyer at Bernstein Liebhard in New York, is representing women who are suing companies that make the transvaginal mesh, with a case going to trial later this year.
"These things were basically put on the market without any significant safety testing," Grand said. "I'm hoping that all of this brings about some regulatory changes."

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

In September 2011 the FDA convened a conference on the use of TV mesh and the consideration for changing its device classification to a more stringent one.

Now the FDA is calling for comments regarding its process of classifying its own process.  You can read more about this here... 


FDA Public Health Notification: Official 2008 warning from the FDA

Serious Complications Associated with Placement of Surgical Mesh 

in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence 

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

READ MORE: TRANSVAGINAL MESH AND WOMEN'S HEALTH

What to consider before choosing surgery -

Alternatives to the laparoscopic Burch and/or paravaginal repair procedures include the following:

• do nothing and continue to experience the loss of urine
• medical (non-surgical) treatment
• lifestyle modification: quit smoking, lose weight, allergy treatment
• Kegel’s exercise: regular contraction of the muscles that allow you to stop urine in mid-stream may reduce or eliminate incontinence
• pessary use: usually a donut-shaped rubber or plastic device inserted into the vagina to support the bladder
• hormonal (estrogen) replacement therapy
• treatment with medication helps certain types of incontinence
• other surgical procedures including
  • the so-called anterior repair (performed from a vaginal approach),
  • other procedures performed in the space between the bladder and pubic bone (may be done at laparoscopy or through a large incision at laparotomy),
  • sling procedures usually done with an incision in the vagina and a 1-2" incision at the pubic hairline,
  • collagen injection (injection of a natural glue-like substance into the bladder neck), and
  • InterStim® - a nerve stimulator is surgically placed to reduce bladder irritability

Many times using a combination of several forms of treatment results in the best treatment for incontinence and paravaginal defects (such as losing weight, stopping smoking, taking estrogen replacement, performing Kegel’s exercise, and having the Burch procedure). If you have any questions regarding the above or any aspect of the proposed surgery, be sure to discuss them with your physician. SOURCE

Request our prevention article

Read more -
http://naturalhealthnews.blogspot.com/2009/03/transvaginal-mesh-and-womens-health.html

http://naturalhealthnews.blogspot.com/p/womens-health-transvaginal-mesh.html

How FDA Approved Mesh 

Graphic Courtesy of Patrick

Latest News on Device Approval from Congress, 13 December, 2011

Read More

Transvaginal Mesh and Women’s Health

Please go to our new page for Transvaginal Mesh and More Updates

Rank 30 Jan, 2012 = 4/158,000

5 January, 2012  -  NEW ARTICLE

Our series on transvaginal mesh is now in PDF format, 26 pages.

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

Mesh Medical Device News Desk

19 December: High Costs Associated with Urogenital Surgery

Cost of surgery for certain urogenital conditions can range from $4000 to $6000 for your doctor with additional costs related to hospital care.

--------------------------------------------

C.R. Bard (NYSE:BCR) may have beaten The Street with its third-quarter results, but Wall Street investors are beating it back today, sending shares down nearly 4 percent.

The medical device maker reported its Q3 earnings and its $250 million acquisition of Medivance after the market closed yesterday. Bard posted profits of $130.1 million, or $1.46 per diluted share, on sales of $719.2 million for the three months ended Sept. 30.

That's 2.0 percent more profit and 6.0 percent more revenues than during the same period last year, when Murray Hill, N.J.-based Bard reported profits of $127.5 million, or $1.34 diluted EPS, on sales of $678.4 million.  October 26, 2011 by MassDevice

FDA Safety Communication: UPDATE on Serious Complications Associated with

 Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

Boston Scientific and other transvaginal mesh makers defend their devices amid FDA probe

Boston Scientific urges the FDA to maintain a class II device status on transvaginal mesh amid calls from public advocates for product recalls and FDA warnings that the devices may do more harm than good.

Johnson & Johnson vaginal mesh lawsuits another blow to the FDA's device review process

October 20, 2011 by Arezu Sarvestani

With high profile recalls in hip implants and defibrillators in the recent past, the FDA's medical device review process takes another hit it doesn't need as health care giant Johnson & Johnson weathers a storm of transvaginal mesh complaints.

 FDA's medical device review process is again under scrutiny as lawsuits pile up against health care leviathan Johnson & Johnson (NYSE:JNJ) for transvaginal mesh devices that may do more harm than good.

Lawsuits claiming negligence against mesh-makers have also implicated the FDA's review system for continuing to clear new mesh products under the 510(k) system, despite the predicate device being pulled from U.S. shelves.

Boston Scientific Corp.'s (NYSE:BSX) ProteGen mesh, cleared in 1996 and pulled from the shelves a year later, was used as a predicate device for clearing subsequent mesh products, despite more than 120 adverse event reports on the original design at the time, Bloomberg reported.

from Bloomberg By Alex Nussbaum and David Voreacos - Oct 20, 2011 J&J Vaginal Mesh Approved by FDA Based on Similar Device Recalled in 1999

More from the FDA

September 29, 2011

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.

Original and complete article from 2009 about TV Mesh Has Moved in order to bring you more updates on this important health issue.

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.  

Please consider a donation to help us continue this important work.

As originally written in 2009, in cooperation with Eric Chaffin, this article has created an internet storm -

Originally posted March 2009 -

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. 

New MESH page has the complete article and much more information.

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.

Read More

Natural Lubrication for Metal Implants

"Natural" graphite lubricant reduces wear on metal-on-metal implants

January 2, 2012 by Emily Greenhalgh

A newly discovered lubricating layer of graphite could be the key to longer-lasting metal-on-metal hip implants, according to researchers.

A study funded by the National Institutes of Health found that lubrication in metal-on-metal hip implants has more in common with the lubrication in a combustion engine than a natural joint.

The study, conducted by U.S. and German researchers, found that a lubrication layer that forms in metal-on-metal hip replacement devices is actually graphite carbon, not proteins as researchers previously suspected.

"Graphite has been used as a lubricant for over a century," study co-author Laurence Marks told Reuters. " It is a classic lubricant, and it appears to form naturally."

When they discovered the graphite lubricant, researchers from Northwestern, Rush University Medical Center and the University of Duisburg-Essen were analyzing 7 retrieved implants to find a way to stop erosion between their metal surfaces.

"This finding opens new avenues of investigation to help scientists understand how joint implants function, and to develop strategies to make them function better," Dr. Stephen Katz, director of the National Institute of Arthritis & Musculoskeletal & Skin Diseases, said in prepared remarks. "The results of such research could have important implications for several 100 thousand Americans who undergo hip replacement each year – as well as those who could benefit from the procedure, but have been advised by their doctors to delay surgery until they are older."

Hip replacements are one of the most common orthopedic surgeries in the U.S. More than 500,000 metal-on-metal implants have been performed so far, according to the FDA.

All-metal joints were designed to be more sturdy and accommodate larger femoral heads than the metal-polyethylene implants they replaced, but several studies found that patients who received the metal-on-metal implants were more likely to need repeat surgeries.

Due to the natural friction of the hip's movement, metal particles can wear off the implants and enter patients' bloodstreams, according to the federal watchdog agency.

"Problematic devices have tended to release more metal debris through wear and corrosion than devices that have performed well," lead investigator Dr. Joshua Jacobs said in prepared remarks. "This debris can cause a local tissue response involving the bone, ligaments, tendons and muscles around the hip."

Lawsuits over the implants have skyrocketed in recent months, topping 5,000 in 2011 – more than in the past 4 years combined.

The NIH researchers seemed optimistic about the lubricant discovery.

"Nowadays we can design new alloys to go in racing cars, so we should be able to do this for implants that go into human beings," Northwestern University professor Laurence Marks said in a prepared statement.

If the research doesn't pan out, growing concern could put the devices on track to be the biggest and most expensive medical implant quagmire since Medtronic (NYSE: MDT) recalled its Sprint Fidelis lead in 2007.

And the high-profile recall of Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics' metal-on-metal ASR implant could cost $1 billion on its own.

All-metal joint replacements haven't just been a target for the federal watchdog agency. The implant woes have garnered the attention of lawmakers as well.

Three U.S. senators are calling for increased safety measures for medical devices, spurred by the attention given to the recalls. Their proposed legislation would beef up the FDA's safety regulations, allowing the federal watchdog agency to conduct safety studies of devices after they've been approved and to grant conditional approvals contingent on further trials.

SOURCE: http://www.massdevice.com/news/natural-graphite-lubricant-reduces-wear-metal-metal-implants


From Natural Health News

Natural Health News: Manufactured Parts and Hip Replacements

Aug 23, 2011 Hip Implant Complaints Surge, Even as the Dangers Are Studied. Originally posted 2009. Total Hip Arthroplasty Every year approximately 200000 hip replacement surgeries are performed in the United States and the success ...

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Avoid Toxic Sweeteners for Weight Loss Goals

Aspartame Warning Flyer for distribution: http://www.mpwhi.com/warning_flyer_on_aspartame.htm

The Lethal Science of Splenda: http://www.wnho.net/splenda_chlorocarbon.htm

Studies have shown that sucralose can:

* Cause the thymus to shrink by as much as 40% (the thymus is your immune powerhouse - it produces T cells)
* Cause enlargement of the liver and kidneys
* Reduce growth rate as much as 20%
* Cause enlargement of the large bowel area
* Reduce the amount of good bacteria in the intestines by 50%
* Increase the pH level in the intestines (a risk factor for colon cancer)
* Contribute to weight gain
* Cause aborted pregnancy low fetal body weight
* Reduce red blood cell count

Particular warning to diabetics: Researchers found that diabetic patients using sucralose showed a statistically significant increase in glycosylated hemoglobin, a marker that is used to assess glycemic control in diabetic patients. According to the FDA, "increases in glycosolation in hemoglobin imply lessening of control of diabetes."

Here is how Splenda is made: http://www.wnho.net/chemical_processing_of_splenda.htm

Ajinomoto just announced a new name for aspartame called AminoSweet. Be warned. It goes under many names; NutraSweet, Equal, Spoonful, Naturataste, Canderel, Benevia, E951, etc. Because the patent has expired it can be used in anything. You must read labels. Many times it’s hidden in artificial and natural flavors. Remember that aspartame has a synergistic and additive effect with MSG. Stuart Pape of the National Yogurt Assn has petitioned the FDA to allow aspartame unlabeled in yogurt and dairy products.


Special warning for diabetics: Aspartame can precipitate diabetes, simulates and aggravates diabetic retinopathy and neuropathy, destroys the optic nerve, causes diabetics to go into convulsions, and even interacts with insulin. The free methyl alcohol causes diabetics to lose limbs. Jeanette Soto, Mission Possible Brookville, Fla, who wrote “Blinded Sight” when her husband lost his sight from aspartame was unable to get her father-in-law, diabetic off aspartame because of the addiction. The free methyl alcohol is classified as a narcotic. It causes chronic methanol poisoning which affects the dopamine system of the brain and causes the addiction. When Jeanette’s father-in-law, Santiago Echiverria died it had to be a closed casket, the formaldehyde from the free methyl alcohol was oozing out of his skin. The American Diabetes Assn was sued in 2004 for racketeering for pushing aspartame on diabetics, but because of their power got out of it.

Today people are dying of the methanol poisoning. Dr. James Bowen explains:
"Only after longer aspartame usage does liver damage cause blood methanol levels to measurably rise because the liver mitochondria are so damaged that the liver no longer quickly processes either methyl or ethyl (drink) alcohol. Then the acute methanol poisoning is directly measurable from lab results, as the blood methanol level elevates. This entire sequence or "toxic axis" begins with your very first dose of aspartame. Both acute and chronic poisonings from this methanol toxic axis, and other additive and synergistic aspartame poisonings, steadily accumulate in the aspartame consumer.” We continue to get reports of people dying of methanol poisoning. Charles Fleming died and his wife, a Sunday School teacher, remains in a prison in Virginia. The detective on the case said, “Diane is innocent but because I was promoted I could not stop the indictment.” Be warned no diabetic should ever consume wood alcohol. The FDA did no NOAEL on methanol. Without it you cannot set an ADI, allowable daily intake. It’s 44% too high.


Just Like Sugar is a safe natural sweetener, see link in right column.

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