Showing posts with label Chaffin Luhana. Show all posts
Showing posts with label Chaffin Luhana. Show all posts

J & J Mesh Bows Out of Mesh BIZ


If you are experiencing problems because of mesh please consider
looking  to our colleague, Linda Kilpatrick, for more information and support, 

Johnson & Johnson is stopping sales of surgical mesh products that aimed to relieve the intense pelvic pain of thousands of women but resulted in numerous reports of injury and several deaths.
The decision is the latest action by the health care giant tackling a range of problem products -- such as bottles of children's Tylenol and other popular over-the-counter medicines, as well as some contact lenses and certain hip implants -- that the company recalled due to manufacturing problems.
The surgical meshes, sold by J&J's Ethicon unit, are among a class of products made by various companies whose safety and effectiveness the Food and Drug Administration warned about in 2008. J&J's meshes are also subject to hundreds of product-liability lawsuits, according to a May securities filing by the company.
The company is planning to halt sales world-wide of Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M mesh products, an Ethicon spokesman said. The company has asked the FDA to allow it to keep selling its Gynecare Gynemesh product, but for insertion through the abdomen only, rather than the vagina as is also currently allowed, the spokesman said.
J&J will be stopping sales over the next three to nine months, with the goal of completing the process by the first quarter of 2013, the company spokesman said.
"This is not a product recall and we continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy," the Ethicon spokesman said in a statement.
The FDA didn't have an immediate comment.
Doctors began using surgical meshes in the 1970s to treat severe cases of a painful condition in which organs like the bladder, uterus or bowel drop down and protrude into a woman's vagina after childbirth. Initially, doctors inserted the meshes through the abdomen to support the organs. In the 1990s, gynecologists began inserting them through the vagina.
Between 2008 and 2010, the FDA received some 1,500 reports of adverse events for meshes made by J&J and other companies. In 2008, the FDA warned about complications including erosion, pain and urinary problems.
Reported June 6, 2012 in the Wall Street Journal
Selections from Natural Health News
Jan 07, 2012
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 ...
Jan 05, 2012
This MESH crap is AWFUL! 2 years now, and will more and likely be lots more, I have suffered and had my whole life turned upside down. its the worst thing possible. What gets me is how long I have to wait to get this crap out ...
Jan 06, 2012
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 ...
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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, 


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.


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.



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.


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
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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, 

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.





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