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Ethicon 3/21
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Pelvic Mesh 101: The Basics
Mar 18, 2016 | Mesh Medical Device News Desk
For women who have received a transvaginal pelvic mesh implant and have developed complications since then, they are often told “it’s in your head,” or “mesh can’t cause pain.” -
$11.75M Settlement Proposed for Caldera Mesh Lawsuits
Mar 18, 2016 | Drug Watch
By Michelle Llamas
Lawyers representing women who say Caldera Medical’s transvaginal mesh implants caused them serious injuries proposed a blanket class action settlement to resolve thousands of lawsuits. -
The NSW Health Care Complaints Commission has confirmed investigations over mesh surgery
Mar 19, 2016 | Newcastle Herald
By Joanne McCarthy
The state’s health watchdog has sharpened its focus on investigations relating to Australia’s unfolding women’s prolapse mesh disaster after serious complaints, including that a doctor allegedly falsely claimed he had ethics approval to conduct a mesh device study at a major public hospital. -
Breakthrough Implantable Material Could Reduce Complications Related to Urinary Incontinence
Mar 18, 2016 | AZO Materials
Scientists at the University of Sheffield have developed a new implantable material, which has the potential to reduce complications for women suffering from urinary incontinence.
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Mar 18, 2016 | Mesh Medical Device News Desk
For women who have received a transvaginal pelvic mesh implant and have developed complications since then, they are often told “it’s in your head,” or “mesh can’t cause pain.”
These pages are full of thousands of anecdotal reports from women who would argue that point- their mesh implant has caused them real pain and a life-altering complications that sometimes are permanent.
Pelvic mesh, sling, transvaginal mesh, TVT, hammock- some of the names for transvaginal mesh. This is not a lawyer-generated story! There are real women suffering devastating injuries from the use of plastic mesh and it continues today!
Becoming your own best advocate and knowing the facts will help you navigate the road ahead!
How Did We Get Here?
“It is just so unbelievable that a “minor problem” outpatient procedure that is minimally invasive causes life changing results. I know my life as I knew it is gone.”~ mesh injured patient
Transvaginal mesh means it is placed through the vagina. This procedure called “minimally invasive” which is a marketing term, and it’s done to suspend pelvic organs that may prolapse through the vagina, a fairly common condition in women as they age, after multiple vaginal births, due to a hysterectomy, as a result of surgery or due to weak collagen. P
Pelvic organ prolapse is known as POP.
Many different organs can prolapse in a woman and they include:
Urethrocele– lower vaginal wall and urethra;
Cystocele-upper vaginal wall and bladder;
Uterovaginal – uterus, cervix and upper vagina;
Rectocele– lower posterior vaginal wall and rectum;
Enterocele – upper posterior vaginal wall and small bowel. POP is measured in four stages from zero to 4.
Page four and five of this FDA page shows the female anatomy and what can go wrong.
These are embarrassing conditions many women do not want to talk about. That’s why I called my original series “Suffering in Silence.” The four-part series from 2009 begins here.
Mesh is also increasingly being implanted in women following a hysterectomy, sometimes prophylactically to prevent a possible future prolapse.
Another condition treated with mesh is stress urinary incontinence (SUI) which occurs when urine leaks during physical activity, coughing, sneezing or laughing. It’s estimated about 13 million American women experience SUI. Mesh to treat SUI is more common than POP mesh.
It’s estimated upward of 60 percent of women will suffer from one or both of these conditions in their lifetime and the FDA reports that in 2010 about 300,000 women had surgery to repair POP with about 3 out of 4 done transvaginally. Market data also shows that 80 percent of the 260,000 SUI surgeries done in 2010 were done transvaginally with mesh.
Transvaginal or abdominally-placed mesh for POP or SUI is intended to be a permanent implant, despite the fact that there were no studies required by the U.S. Food and Drug Administration for safety and efficacy!
That’s right, none.
The majority of medical devices make it to market via the 510(k) approval process, which is essentially an “approval” to sell. All a manufacturer has to do is to say their device is the “substantial equivalent” of another device already on the market. Exchange paperwork, a few thousand dollars, about 60 to 90 days and Voila! Your device is generally approved by regulators at the FDA.
FDA WARNINGS
Did your implanting physician tell you the FDA had issued two warnings about polypropylene mesh in the U.S? Health Canada has also issued warnings.
Polypropylene is derived from petroleum and was developed in the 1950s as a thermoplastic polymer resin that can be molded into many forms. Mesh manufacturers molded the plastic into fibers for sutures. Polypropylene knitted mesh using monofilament yarns make textile fabrics and indoor-outdoor rugs.
Synthetic mesh was first used for hernia repair in the 1950s but sometime in the 1990s it began to be used for POP and SUI. By 1996 the FDA cleared the first surgical mesh product for use in SUI and in 2002 for use in POP. The introduction of pre-cut “kits” corresponded with weekend cadaver training sessions offered by mesh manufacturers.
Gynecologists, were schooled by the manufacturers how to implant the plastic mesh with the aid of a kit including pre-cut mesh, needles and sutures.
Almost immediately complications were noted. From 2005 to 2008, the U.S. Food and Drug Administration noted it had received more than 1,000 reports of complications associated with mesh.
They can include:Erosion through the vaginal epithelium and tissues;Infection;Perforation of bladder, rectum,Urinary problems;Internal bleeding;Recurrence of prolapse and/or incontinence;Vaginal wall narrowingNerve entrapmentVaginal scarring;Dyspareunia (painful sexual intercourse)Death
“I’m so tired from the struggle & the wait for proper medical attention. My heart is growing weary after five years I am getting worse & scream out to even get up & set down . The getting up is worse , I draw double holding my lower abdominal area where there is an open hole that bleeds.”
By October 2008 when the FDA issued a Public Health Notification concerning transvaginal mesh, it said there were more than 1,000 reports of “adverse events,” as the FDA calls complications. The events were serious but “rare,” according to the FDA. See the FDA 2008 Public Health Notification here.
Then in July 2011, the FDA (here) reported that complications associated with transvaginal mesh to treat POP increased five-fold; that “serious complications associated with surgical mesh for transvaginal repair of POP are “not rare” and that transvaginal mesh used for POP repair “does not improve symptomatic results or quality of life over traditional non-mesh repair.”
It was after the second FDA warning that product liability or defective product lawsuits began to be filed.
Nine manufacturers are the focus of litigation, they include: Johnson & Johnson (Ethicon, GYNECARE), C.R. Bard, American Medical Systems, Boston Scientific, Endo Pharmaceutical Holdings (AMS), Caldera and Covidien, among others.
The FDA issued a White Paper “Urogynecologic Surgical Mesh” about the same time which is an excellent resource here.
See Diana Zuckerman from the Center for Women and Families, and her excellent piece on 510(k) published in the Archives of Internal Medicine here.
If you a re experience some of these symptoms, you may want to reach out to an attorney, please click here.
The Problems: Recalls
Even today women are often told the “bad mesh is off the market.” In most cases this is misleading because the vast majority of meshes are still on the market, even the ones that have been found defective in a court of law!
Those would include the TVT-O (transobturator tape) and the TVT (transvaginal tape).
In June 2012, Ethicon (Johnson & Johnson) announced it was discontinuing the sale of four synthetic transvaginal meshes from its Gynecare division. Here is background story from Mesh Medical Device News Desk.
This was not a recall. J&J said it was making the move for financial reasons.
What was recalled was the ProteGen, a mesh made by Boston Scientific which was the “predicate” named by many of the meshes on the market today. It was found not to functions as intended, in other words it was defective. A great resource on the ProteGen predicate was done by a mesh injured woman who I’ve found to be very credible and an excellent researcher. It appeared on iCNN here.
However, that finding about the ProteGen did NOT spark a re-review of all of those meshes that had named it as their predicate device. Sort of like a generation of Pinto-like cars being left on the market after the Pinto was recalled!
What’s New?
Federal courthouse, Charleston, WV
The federal court began consolidating mesh cases in Charleston, WV in January 2012. This is called multidistrict litigation (MDL) and it is intended to smooth the process for the background research of these cases (called discovery) and to have consistent court rulings.
In an MDL, you are awarded any settlement monies based on your degree of injury, unlike a class action where everyone gets an equal slice of the pie.
But the pace of this litigation has been very slow. So far “bellwether cases” so named for the bell on a lead sheep, which are supposed to test the waters on legal theories and have both sides come to an agreement, have been few and far between. There are now, in early 2016, more than 86,000 case filed in this federal court in Charleston before Judge Joseph Goodwin.
An MDL has never had so many cases filed in one court and frankly the court cannot handle it.
The cases that have been heard are generally favorable to the plaintiff- the woman- who is awarded anywhere from $2 to $100 million. (that number was later reduced to $10 million). Immediately after a jury verdict, the defendant mesh maker will file an appeal. So far only one plaintiff who went to trial has received her compensation.
Right now it appears to be a waiting game with the largest mesh maker, Johnson & Johnson, which is slow to the settlement table and instead has opted to defend itself in court. Other mesh makers have settled cases, though settlement dollars are usually disappointing and not intended to fund a lifetime of medical needs.
From the FDA front, the FDA decided to give mesh makers 30 month to prove their products are safe and effective ( something that might have been done before approval!) or they will have to come off the market. This applies ONLY to POP mesh NOT to SUI mesh. It is assumed mesh makers will have quite the challenge to prove safety so it remains to be seen whether POP mesh will survive. Unfortunately, they have 30 months to continue to use it.
Mesh for incontinence (stress urinary incontinence or SUI) will be allowed to stay on the market. Mind you that there are far more defective product lawsuits filed over SUI mesh, incontinence mesh.
The FDA had stated it would watch the complication reports from SUI mesh instead. Last time this reporter asked, the FDA told me they didn’t know how many injuries were they were receiving concerning SUI mesh.
How to Report an Adverse Event:
So that leads to this- how to report your injury to the FDA! This is very important to do. This is for pelvic mesh only, hernia mesh complications should also be reported.
First, know what brand mesh you have (Boston Scientific, Ethicon/J&J/ Gynecare- all J&J). You will get this from your medical records. Get those records!
So how do you report to the FDA? Here is a story from August 2014.
You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:By phone- 1-800-FDA-1088By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
MedWatch Online Voluntary Reporting Form (3500) is here.
Look up Adverse Events:
Manufacturer and User Facility Device Experience (MAUDE) data
As it stands now, the injured have to find the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database) and understand the criteria to enter to pull up injuries resulting from your mesh. It can be intimidating, and if they are involved in litigation are generally advised not to enter information.
For example, in the case of mesh patient, Suzanne McClain (Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the criteria:
1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)
2.) Brand Name: Tension Free
3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.
4.) Records Per Report Page: Change to 500 and click Search.
The Problems: How Women are Treated
POP and SUI are considered “conditions” and are an inconvenience, generally not painful, but are embarrassing. Most women do not talk about the condition and many find it embarrassing even to talk about complications that result from surgery.
That may be one reason the surgery option continues today – women are embarrassed to speak to their doctor about complications. Symptoms may be general in nature and the woman may not associate her symptoms with mesh and doctors who receive their primary education from the mesh makers and their sales reps may not be equipped to handle complications.
Women suffering after a mesh implant often hear, “You’re the only one who is having these problems.” Women suffering complications are frequently told they are depressed and told to visit pain management and to take antidepressants. Many women talk of unending chronic pain, infections and a continuing denial from their doctors.
These stories are repeated over and over.
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$11.75M Settlement Proposed for Caldera Mesh Lawsuits
Mar 18, 2016 | Drug Watch
By Michelle Llamas
Lawyers representing women who say Caldera Medical’s transvaginal mesh implants caused them serious injuries proposed a blanket class action settlement to resolve thousands of lawsuits. The deadline to join the settlement is May 2, 2016.
More than 2,000 mesh lawsuitspending in California State Court in Los Angeles will be included in the proposed $11.75M settlement. According to plaintiffs, Caldera failed to warn the public about the risks of its mesh products, Lawsuits also assert that Caldera is guilty of fraud and deceit.
“The Court still has to decide whether to approve the Settlement and whether to certify the Settlement Class. Payments will only be made if the Court approves the Settlement,” according to the Notice of Proposed Class Action Settlement.
Transvaginal mesh is a net-like piece of porous plastic that surgeons use to treat incontinence and pelvic organ prolapse in women. Thousands of women claim theseimplants caused them permanent injuries such as organ damage, inability to have sex and nerve damage. Many women undergo multiple surgeries to try and remove the mesh.
The final approval hearing for the Caldera settlement is slated for June 13 in Los Angeles before U.S. District Judge Stephen V. Wilson. This settlement is separate from the thousands of cases in federal multidistrict litigation in West Virginia before Judge Joseph Goodwin.Other Manufacturers in Settlement
In addition to Caldera, a handful of manufacturers include Biomedical Structures, Encision, Parker Hannifin, J-PAC LLC and Coloplast — a company that previously issued a settlement.
Caldera products included in the settlement include:T-SlingDesaraAscendHydrixPOPmeshVertessa
“If the Settlement is approved by the Court, those included in the Settlement Class will receive a cash payment from the Settlement Fund. You must file a Claim Form to get payment. Your legal rights are affected whether you act or don’t act,” Caldera said in its notice.
Plaintiffs who already filed lawsuits are automatically entered into the settlement and are entitled to submit a claim form for compensation from the fund. Those who have not yet filed a lawsuit may still join the settlement.
Caldera continues to deny the allegations set forth by plaintiffs.Trial for 37 Federal Mesh Cases Rescheduled
A trial for 37 consolidated mesh lawsuits that are a part of the massive Ethicon MDL in West Virginia will be moved to a later date. Previously scheduled for April 11, 2016, the trial may continue sometime in August or September. There are still more than 70,000 lawsuits pending before Judge Joseph Goodwin in West Virginia against a number of manufacturers.
According to Judge Joseph Goodwin’s Pre-Trial Order #217, all discovery and proposed trial exclusions should be completed. Discovery involves all depositions and requests for information from both sides. After this stage, the trial can continue.
In February, Drugwatch reported on the planned Mesh Awareness Movement rally. The women of the group planned to protest in front of the court house on April 11 to support the 37 women. The rally will now be rescheduled.
“A lot of people who were going to the rally were disappointed and angry,” Janis Urban of MAM told Drugwatch. “Women are getting annoyed and upset at all these delays in the MDL.”
She said the rally planned for June 3 from 8am to 11am for Edwards v. Ethicon is still scheduled to go through in front of the Robert C. Byrd courthouse in Charleston, W. Va.Congress Needs to Investigate ‘Regulatory Negligence’
Urban said congress needs to investigate mesh manufacturers’ “regulatory negligence.”
“We have a lot of women that write their congressmen and senators with no response. The only response I ever got was instructions on how to file a MAUDE adverse event report with the FDA,” she told Drugwatch.
For now, MAM is focusing its mesh awareness efforts to social media. The women are trying to hold manufacturers accountable.
“We have Twitter parties to raise awareness every Friday from 8pm to 11pm. This week, we are going after Johnson & Johnson,” she said.
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The NSW Health Care Complaints Commission has confirmed investigations over mesh surgery
Mar 19, 2016 | Newcastle Herald
By Joanne McCarthy
The state’s health watchdog has sharpened its focus on investigations relating to Australia’s unfolding women’s prolapse mesh disaster after serious complaints, including that a doctor allegedly falsely claimed he had ethics approval to conduct a mesh device study at a major public hospital.
NSW Health Care Complaints Commission executive officer Kathryn Borkovic confirmed on Thursday that the commission is investigating complaints made against a number of doctors following their use of transvaginal mesh devices during women’s prolapse surgery.
The complaints from patients and at least one doctor include that women did not give informed consent to have mesh devices implanted, were not warned of alternatives available, were not adequately warned of the risks involved, were not warned of the risks of different types of transvaginal mesh, and were left with serious and permanent injuries that often required multiple follow-up surgeries.
Ms Borkovic declined to respond to specific questions about the HCCC investigations.
“These investigations are ongoing and to protect the integrity of the investigations the commission is not proposing to provide more detailed information at this stage,” she said.
Medical Error Action Group founder Lorraine Long said it was appropriate to refer to the mesh device “disaster” because of the failure of regulators in Australia and overseas to adequately assess the devices, monitor problems and respond quickly.
The Therapeutic Goods Administration’s admission its assessment of the mesh devices from 2003 was not “mature” and lacked rigour was not a surprise, Ms Long said.
“That says everything, doesn’t it? It’s not good enough,” she said.
A federal Review of Medicines and Medical Devices Regulation in March 2015 found while the Therapeutic Goods Administration had an excellent reputation for ensuring high quality and safe medicines on the Australian market, its “performance in respect of devices is less notable”.
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Breakthrough Implantable Material Could Reduce Complications Related to Urinary Incontinence
Mar 18, 2016 | AZO Materials
Scientists at the University of Sheffield have developed a new implantable material, which has the potential to reduce complications for women suffering from urinary incontinence. Extremely rigid materials, which are used to treat urinary incontinence, can cause adverse side-effects.
Stress urinary incontinence is a medical condition, where pressure on the bladder caused by laughing, sneezing, or exercise, and often due to the menopause, surgery or childbirth, results in urine leakage. It has been estimated that about 3 to 6 million people in the UK suffer from some form of urinary incontinence.
The study results have been reported both in the Journal of Urology and the PLOS ONE journal. They provide sufficient proof that a material that is soft and flexible can be used to support the urethra. A recent study has highlighted the long-term effect of vaginal childbirth delivery. Such procedures can double the risk of stress urinary incontinence.
Existing treatments involve the use of a stiff woven polypropylene mesh device, which is implanted beneath the urethra to repair weakened or damaged tissues. The material used in the polypropylene mesh device was actually developed for hernia repairs, but this was repurposed in the mid-1990s for surgical treatment of urinary incontinence. This practice is now being followed worldwide.
Most women who suffer from urinary incontinence opt for surgery. In fact, the NHS performs about 13,500 operations every year to treat such conditions, including pelvic organ prolapse. Over the past decade the use of the current material has caused complications in many patients following stress urinary incontinence surgery. It has been estimated that about 15% of women can develop serious complications such as infection, chronic pain, or erosion or failure of the implant.
In collaboration with international collaborators in Europe, Sheffield's Centre for Biomaterials and Tissue Engineering Group has developed a new implantable device with elastic polyurethane. This flexible polyurethane simulates the natural recoil of a normal pelvic floor.
In younger women, the organs of the pelvis have a strong and elastic pelvic floor, supported by a combination of connective tissue, muscles and ligaments that provide 'a well-sprung floor', much like a trampoline. Unfortunately, one of the consequences of pregnancy is that there is often damage and weakening to the tissues of the pelvic floor, as it becomes further stretched, with a resulting loss of elasticity. After 6 years of product development and pre-clinical testing, the elastic polyurethane material we have rigorously tested is neither too strong nor too brittle, it does not weaken over time and aims to avoid the complications that currently occur with using polypropylene mesh.
Professor Sheila MacNeil, Department of Materials Science and Engineering, University of Sheffield
The device has been tested by implanting in physiologically pertinent animal models via a European collaboration with colleague Professor Jan Deprest in Leuven. This is a major aspect of pre-clinical studies, to discover if the implanted material is indeed compatible or not. This also underlines the fact that the new device is suitably integrated into the tissues and causes relatively less inflammatory reactions, compared to the existing polypropylene mesh device. Sheffield’s study could set the stage for clinical testing of this device and end the pain and complications experienced by thousands of patients across the globe.
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