Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Friday, June 30, 2017

The FDA Owes Patients Improved Medical Device Regulation After Dr. Amy Reed's Death

Kirsten Clodfelter  JUN 30, 2017 @ 07:05 AM   FiDA highlight

Dr. Amy Reed, an anesthesiologist and patient-safety advocate, died in May 2017 after a four-year battle with leiomyosarcoma of the uterus. The cancer was spread by a power morcellator, the medical device used for her 2013 hysterectomy.
The surgical tool, released in 1995, was once lauded for facilitating minimally invasive surgery that decreased recovery times and minimized the risk of post-surgical infections. Morcellation, used to remove uterine fibroids or conduct complete hysterectomies, was performed on approximately 50,000 women a year in the U.S. in the early 2010s.
Yet for patients like Dr. Reed, whose uterine fibroids appeared benign but hid an aggressive type of cancer, morcellation can become a death sentence. The device is equipped with a spinning blade, which slices up tissue for removal piece by piece through small incisions. When the blade cuts through a cancerous tumor, it sprays malignant cells around the body, spreading the disease. Following her procedure, Dr. Reed, a mother of six, was left with advanced, Stage 4 cancer.

Monday, June 26, 2017

J&J hips, mesh, Bayer Essure: FAILED devices: webinar HealthwatchUSA

Joleen Chambers, a resident of Dallas, TX,  is a 2010 FDA/CDRH-trained Patient Representative with an M.S. in Rehabilitation Counseling.  She is a national patient advocate for patients PREVENTABLY harmed by implanted medical devices such as Bayer Essure, pelvic and hernia surgical mesh and toxic metal-on-metal hips.  Joleen is a graduate of Leadership America 2010, board member of Leadership Women and HealthWatch USA.  Recently she has been an observer at state and federal jury trials and a protester at several corporate shareholder meetings.  Please visit her blog, Twitter @JjrkCh and Facebook  Joleen Chambers.

Title of 6/21/2017 presentation:

An Update on PREVENTABLE Medical Device Harm:  Indemnity & Justice
Keynote Slides 1-10

Saturday, June 10, 2017

Governor Chris Christie, Medical Device Industry Kick Backs & History Repeats Itself Ad Nauseam

on June 11, 2010 at 9:17 AM, updated June 11, 2010 at 9:20 AM  FiDA Highlight

A stabbing pain in the hip forced Mark Hirschbeck to abandon his post at third base during an April 2003 game between the Arizona Diamondbacks and the Colorado Rockies.
He was 42, among the best umpires in professional baseball and unwilling to quit a job that paid more than $350,000 a year. Dr. John Keggi offered a hip replacement that could get him back on the field by 2004, Hirschbeck says. That didn’t happen. The ceramic joint made by Wright Medical Group Inc. shattered, leading to an infection and four more surgeries that left Hirschbeck permanently sidelined.
He later learned that Wright paid tens of thousands of dollars to a foundation Keggi helps run and gave him a trip to a conference in the Bahamas. Keggi recommended the ceramic device over the kinds of implants used in 97 percent of cases.
“He was in bed with Wright and picked their product,” says Hirschbeck, who is suing the company and the surgeon, alleging Wright’s product was defective and Keggi failed to install it correctly. “It’s disgusting it would come to that.”
Wright’s professional agreements with surgeons are under investigation by the Justice Department, according to filings with the Securities and Exchange Commission. It’s not clear whether the payments to Keggi were improper or are being examined by prosecutors, who declined to comment. The company and the doctor have denied the allegations in the umpire’s suit.
‘Truly Extraordinary’
Andrew Mills/The Star-Ledger
Gov. Chris Christie holds a town hall meeting before a capacity crowd at the Roxbury Township Municipal Complex in Morris County to discuss property tax plan and affordable housing, June 10, 2010.
The government declared last year that it had overhauled the financial relationships between surgeons and the biggest makers of knees and hips, saying the threat of criminal prosecution for “kickbacks” had forced them to slash payments to physicians. Results of the crackdown were “truly extraordinary,” said Chris Christie, a former U.S. attorney for New Jersey who is now governor, in testimony to Congress in June 2009.
It was too good to be true. Compensation ended up being higher after the September 2007 deferred prosecution agreement because payments were postponed, according to data compiled by Bloomberg and interviews with seven surgeons.
“It’s back to business as usual,” says Charles D. Rosen, president of the Association for Medical Ethics, who is a spine surgeon in Irvine, California. “Nothing will change until someone goes to jail. It’s a big game.”
Prosecutors in the New Jersey U.S. Attorney’s Office, which headed the case, reported a “satisfactory completion” in March 2009 of the probe of Biomet Corp., Johnson & Johnson’s DePuy unit, Smith & Nephew PLC, Zimmer Holdings Inc. and Stryker Corp. Payments in 2008 fell to $105 million from $272 million the year before, the Justice Department lawyers said.
‘Common Happenstance’
The companies increased doctor compensation for 2008 to about $300 million, according to the data compiled by Bloomberg from reports posted on the device makers’ websites. Fees for 2008 were delivered in 2009, the surgeons say.
Payment delays were “a common happenstance,” says Teresa Ford, a Seattle attorney who represents 150 doctors who have consulting or royalty agreements with orthopedic device makers. “None of them had significant changes in their relationships.”
The government numbers were lower than those reported by the companies because Justice Department officials didn’t count payments made to buy out the consulting contracts of some physicians, says Michael Drewniak, a spokesman for Christie, a Republican who resigned in December 2008 to run for governor. A “large number” of implant makers paid to end multiyear arrangements, Drewniak says, because they might not comply with new standards under the settlement.
$300 Hips
“We weren’t just making up numbers,” Drewniak says.
Justice Department officials declined to comment.
The reports on the company websites don’t specify whether any payments were to buy out contracts.
The financial ties between device makers and surgeons help explain why health-care costs in the U.S. rose at 2.5 times the rate of inflation in the past 10 years and account for a sixth of the economy. The $300 million works out to $300 for each of the 1 million hips and knees implanted in Americans in 2008.
The payments show how hard it is for government to hold down costs in a system where pricing is opaque and largely unregulated. In the $14 billion-a-year orthopedic device business, payments to doctors squelch competition, says Chad Rodine, a partner in Castle Rock, Colorado-based Echelon Consulting LLC, which advises hospitals on implant costs.
Four Times Higher
Hip and knee list prices have increased 5.6 percent so far this year, on top of a 130 percent increase in the average selling price of a hip between 1996 and 2008, according to Orthopedic Network News, a trade journal that tracks costs.
In the U.S. in 2010, the average price of a primary artificial hip was $7,200, more than four times the $1,600 in Germany, says Melissa Hussey, a senior analyst on the orthopedic team at Millennium Research Group, based in Toronto. In Germany and other countries, she says, sales representatives have restricted access to surgeons.
“These items are ridiculously expensive, and a lot of the monies in that bucket are to keep the surgeon tied to that product,” Rodine says. He figures about half the price charged for devices can be traced to funds companies pour into persuading doctors to pick their goods.
Device makers work to form bonds early, in medical school, where they underwrite residency programs, or buy books, or sponsor fellowships. Later, they pay surgeons as consultants, speakers or instructors.
Sales Rep’s Car
Company sales representatives attend operations. The reps enjoy wide access to surgeons at a time when some hospitals are moving to limit the interactions that pharmaceutical representatives have with doctors. Academic medical centers, including Stanford University and Yale University, restrict when and where drug company salespeople can visit doctors, and ban them from patient areas.
The connection between device makers and surgeons is hard to break, says Jeffrey Lerner, chief executive officer of the ECRI Institute in Plymouth Meeting, Pennsylvania, which collects pricing data.
“The relationship between the manufacturer and surgeon is so deep,” Lerner says. “The first thing they want to see when they pull into the hospital in the morning is their manufacturer representative’s car.”
As joint replacements became more complex and numerous, implant makers increasingly relied on surgeons to help them develop new products and train colleagues. Physicians became involved in testing new implants.
‘Routinely Violated’
“Engineers don’t know how to do it,” says Joseph Zuckerman, an orthopedic surgeon at NYU Langone Medical Center who has worked as a consultant. “Advances in the design of orthopedic devices would not be possible if physicians were not part of the development process.”
Along the way, according to government investigators, the system was perverted so that many consulting deals, royalty agreements and trips to conferences were intended not to develop better products but to persuade surgeons to use a company’s products. The government charged that the industry “routinely violated the anti-kickback statute by paying physicians for the purpose of exclusively using their products.”
Federal prosecutors began looking into the incentives in 2005. The government’s settlement was with the five companies that make 95 percent of artificial hips and knees. They agreed to an 18-month monitoring plan. Four of the producers also paid $311 million in fines to settle civil complaints filed under the Federal False Claims Act. Stryker was monitored, not fined.
Ashcroft’s $52 Million
Since the agreement, payments to surgeons have been appropriate and for legitimate purposes, according to spokespeople for the five companies. Wright says on its website that it adheres to industry ethical standards in its dealings with consultants.
As for 2008 fees that weren’t delivered until 2009, three of the companies say they froze payments while monitors were reviewing contracts with surgeons to ensure they were proper. Spokesmen for Stryker and Smith & Nephew declined to comment. Three of the court-appointed monitors say they’re barred from talking about the details of their work. The two others, including former U.S. Attorney General John Ashcroft, didn’t return telephone calls. The department declined to release reports the monitors filed.
‘Paying the Price’
A month after the government closed its case, Zimmer CEO David Dvorak told analysts on a conference call that the action didn’t result in a “material change” to what it pays surgeons. Warsaw, Indiana-based Zimmer is the largest implant maker, with 2009 revenue of $4 billion.
Christie was criticized by some members of Congress for appointing Ashcroft, his one-time boss, to monitor Zimmer. Zimmer said then that it would have to pay Ashcroft’s consulting firm as much as $52 million, and complained about the amount.
The biggest change from the settlement is more paperwork, surgeons say, because they have to document in greater detail the work they do. Some say companies have been stricter with entertainment expenses and have cut the number of meetings at resort locations.
“No one is really paying the price,” says U.S. Representative Bill Pascrell Jr., a Democrat from New Jersey. Deferred prosecution deals “don’t work.”
In June 2003, Hirschbeck says, a Wright salesman was in the operating theater when his ceramic hip was installed at Waterbury Hospital in Connecticut, which the former umpire says he was stunned to learn later.
“I didn’t know this guy,” he says. “What right does he have to be there?”
2001 World Series
Back then, Hirschbeck says, he knew next to nothing about artificial implants or the companies that make them. Stout, of medium height and with a fondness for flat-top haircuts, he loved his job, and just wanted to find a way to do it pain-free.
He’d had his moments in the baseball sun. He umpired two World Series, including in 2001 when he became part of the story in game 2 between the New York Yankees and the Diamondbacks. In the 8th inning, Hirschbeck called Yankees third baseman Scott Brosius out on strikes. The Yankees were being shut out. An irate Brosius was soon in Hirschbeck’s face, and a photo of the confrontation ran in sports pages.
“I was about to throw him out,” says Hirschbeck, whose bother John is also a Major League umpire. He didn’t. Brosius backed off and the Yankees lost the game 4-0 and the series 4 games to 3. “It was the most pressure I ever felt. One bad call could ruin your entire winter.”
Cortisone Shots
After joining the major leagues following an eight-year tour in the minors, he was reaping the rewards. But getting into position behind home plate was starting to mean a jolt of piercing pain in his hip, he says, akin to being stabbed with a sharp knife. Cortisone shots provided temporary relief.
Then pain forced him off the field in Phoenix, and he started doing his homework on orthopedic surgeons. His choice of John Keggi of Middlebury, Connecticut, was motivated not just by Keggi’s reputation -- “I heard he was the best in the state,” Hirschbeck says -- but by the notion that he could recuperate close his own home in Shelton, Connecticut.
While some others recommended metal implants, Hirschbeck says Keggi pushed a new ceramic hip from Wright. “I will have you back on the field within a year,” Hirschbeck says Keggi told him. Keggi, in a deposition taken in Hirschbeck’s lawsuit, said he told Hirschbeck the replacement “may allow you to return to work” and that the ceramic hip “had the best chance of lasting the longest.”
Splintered Pieces
Less than two months after surgery, Hirschbeck was on the couch, watching TV, when he heard a pop. The pain was intense; the hip had shattered. On July 26, Keggi opened the patient up, picked out the splintered pieces and installed another ceramic implant. Within a month, Hirschbeck was back on the table.
This time, an infection had developed; Keggi washed the joint out and removed infected tissue. The pain didn’t go away, Hirschbeck says, and he his wife decided to seek out a new doctor, visiting the Hospital for Special Surgery in New York City, which performs the most replacements in the U.S.
A specialist there told Hirschbeck his hip was infected, he says, and delivered an additional jolt of bad news: Fixing the problem would mean taking out the joint and putting in a temporary spacer loaded with antibiotics. That would stay in until the infection cleared. Hirschbeck consented.
$344,813 Bill
For all of September and most of October in 2004, he lay in a hospital bed in the family room. Nurses visited daily to administer additional antibiotics. His wife emptied his bed pan. When he returned to New York in the back of his van in late October to receive yet another hip, he got a combination of components from Zimmer and Waldemar Link GmbH & Co. That operation, his fifth in 16 months, was successful.
There are an estimated 80,000 revisions of hip and knee replacements in the U.S. each year in which an artificial joint is removed because it is causing pain, became loose, failed or is limiting a patient’s mobility, according to a study published in 2007 in the Journal of Bone & Joint Surgery.
The bill for all his repairs was $344,813, Hirschbeck says, mostly covered by workers’ compensation.
In September 2005, Hirschbeck sued Keggi and Wright in Connecticut Superior Court. Keggi’s lawyer, Eugene Cooney, says in an e-mail that his client “has denied these claims and intends to fight them.” Keggi declined to comment.
‘Cooperating Fully’
Officials with Wright, which has denied liability, won’t answer questions about Keggi, Hirschbeck or its products while the suit is pending, according to Tom McAllister, assistant general counsel for the Arlington, Tennessee-based company. It’s the sixth-largest hip and knee maker, with revenue of $487.5 million last year.
Wright is “cooperating fully” with the Justice Department probe that began with a December 2007 subpoena, according to a May 5 filing with the SEC. It’s “probable” there will be a settlement that may require a payment of about $8 million, the company says in the filing.
Keggi, in a deposition, said Wright had given grant money, though he didn’t know how much, to the Keggi Orthopaedic Foundation, where he said he is director of research and his uncle, Kristaps Keggi, is president. “The Keggi foundation was paid nominal sums by various product manufacturers to collect data on the results of hip replacement surgeries,” Cooney says.
Keggi and his uncle, also an orthopedic surgeon, jointly owned the practice at the time of Hirschbeck’s ceramic implant.
Bahamas Conference
Kristaps Keggi was a clinical investigator for the trial by Wright to get its ceramic hip approved for sale in the U.S. The Wright website features testimonials from two patients of Kristaps Keggi touting the company’s ceramic hip.
John Keggi said in his deposition that he attended a Wright conference in the Bahamas and brought his wife. He couldn’t remember the dates or details, according to his deposition. Keggi said the Wright salesman at the time for Connecticut, Scott Fitzgerald, was usually in the operating room to instruct him on the installation of implants. In his deposition, Fitzgerald said that before joining Wright, he had worked in the ski industry and sold outdoor power equipment.
Keggi no longer uses the Wright ceramic hip, having switched to a joint made by Smith & Nephew, he said in his deposition. Last year, Smith & Nephew paid Keggi $25,001 to $50,000 for consulting work and reimbursed him for $7,061 in travel and meal expenses, according to financial records posted on the company website.
The company’s physician-consultants are “compensated fairly” and their input is “central to the development and introduction of new orthopedic medical device technology,” says Andrew Burns, a spokesman for London-based Smith & Nephew, in an e-mail. The company is the fourth largest hip and knee maker with revenue of $3.8 billion last year.
In Ansonia, Connecticut, Hirschbeck lives alone, collecting disability from the league, about 40 percent of his former pay. His marriage ended in divorce, partly, he says, because of the stress of his multiple surgeries.

“I’m miserable,” he says. “It screwed up my life big- time.”

Thursday, June 8, 2017

FDA Fails to Protect Patients from PREVENTABLE Bayer Essure Harm.

Updated: JUNE 6, 2017 — 7:38 PM EDT

by Marie McCullough, Staff Writer
The ranks of women harmed by Essure sterilization coils continue to grow, while the U.S. Food and Drug Administration’s efforts to inform them of the risks are not working, a 37,000-member advocacy group declared Tuesday.

Administrators of the six-year-old Facebook group Essure Problems said that in the first quarter of this year, the FDA received about 2,000 reports of women who underwent operations — usually hysterectomies — to remove coils that were causing complications such as pain and bleeding.
More than 9,000 removals have been reported since 2009, in addition to miscarriages, fetal deaths, and other problems, according to an analysis of the FDA’s “adverse events” reporting system. It was conducted by Madris Tomes, a former FDA manager who is the founding CEO of Device Events, based in York, Pa.

Angie Marie Firmalino, 44, a co-founder of the Essure Problem group on Facebook
“More than 15,500 adverse-event reports have been filed,” said Essure Problems cofounder Angie Marie Firmalino, 44, of Tannersville, N.Y., who needed a hysterectomy to get rid of fragments of broken coils. “We feel like the FDA needs to step in and take action. How much harm is acceptable for a non-lifesaving device?
Asked for comment, the FDA said it “continues to review the available information about Essure, including reports of problems submitted to the FDA.”

The manufacturer, Bayer Healthcare, emailed: “We take all adverse events seriously. … We have reached out to many women who have reported complications … and provided any guidance we can. There are risks with all medical procedures.”

Surgeries to Remove Essure
This analysis of data from the FDA’s voluntary adverse events reporting system shows how many women needed surgery — either hysterectomy or fallopian tube removal — to remove the Essure sterilization coils because of severe problems such as pain and bleeding. Reports have been steadily increasing with growing awareness of the dangers.

Essure Problems has been among those pushing the FDA since 2013 to take Essure off the market. The coils, approved 15 years ago, are implanted in the fallopian tubes to scar them shut. The device is marketed as a simple, nonsurgical alternative to conventional tubal surgery.
Last year, the FDA ordered Bayer to add label warnings that Essure can cause chronic pain, organ perforation, and allergic reactions, and to create a “patient decision checklist.”
But about 200 women have contacted Essure Problems over the last six months to say that doctors did not tell them about the label warnings or use the three-page checklist.
“Unfortunately for many women, they are being implanted without informed consent,” administrators of the Facebook group emailed the FDA on Monday, demanding tougher action.
The FDA’s response, shared by the group: “We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration.”
Bayer, which acquired Essure in 2013, has been hit by thousands of lawsuits over the coils. Last year, the German-based company’s annual report said it incurred losses of $413 million in connection with the devices.

Bayer has said it does not know how many women have implants, just that about a million Essure “kits” had been sold worldwide, most in the U.S. The company recently announced it would discontinue sales in two small markets, Finland and the Netherlands.

Wednesday, June 7, 2017

Bayer Essure: Banned in Finland, the Netherlands, England, Wales, Scotland, Northern Ireland and Brazil

Holly Kelly Ennis
June 7, 2017  FiDA highlight
Victims of Essure celebrated again today after learning that the controversial Essure Sterilization device will be discontinued in the United Kingdom as of September 1, 2017. This follows on the heels of Essure being banned by Brazil in February and recently discontinued in Finland and The Netherlands, with rumors of other countries to follow by the end of the Summer. Bayer recently confirmed it will discontinue sales in the United Kingdom set forth in the letter below:

As Bayer discontinues the sale of the Essure device or countries ban it outright, this exerts greater pressure on the FDA to take affirmative action regarding  pulling the device from the market. For over three years, since the Essure Problems Administrators first shared their valid concerns regarding the device, they have heard the same tired response from the FDA, "We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration." Obviously, the FDA is not hearing the Group's concerns, nor is it a high priority.  In fact, despite repeated pleas from the Group regarding the making the Black Box Warning mandatory to physicians, the FDA designated it as a "guidance."  Accordingly, over 200 hundred women have contacted the Group since the BBW was implemented on November 15, 2016 to report that doctors failed to mention the BBW or use the Patient Decision Checklist.
The FDA responded yesterday that it, "continues to review the available information about Essure, including reports of problems submitted to the FDA."  These reports now total over 15,000 with over 9,000 reports of surgical removals since 2009. How long will the FDA continue to "review" the horrific stories of ladies significantly injured by the device before it takes some definitive action and revokes the PMA for the device? The job of the FDA is to protect the health of American citizens, not line the pockets of pharmaceutical and medical device companies. FDA, it  is time. Do Your Job. 

Questions regarding the Essure Sterilization Device can be directed to attorney Holly Ennis at 1-800-856-6405 or visit us online at

Tuesday, June 6, 2017

The Biggest Global Health Disaster of Our Time: Surgical Mesh

PUBLISHED: 20:06 06 June 2017  FiDA highlight

One in three women could be suffering in silence with mesh implant problems in a women’s health scandal that has been called the biggest disaster of our time.

One of the risks of pelvic mesh implants is loss of sex life due to chronic burning and cutting pains or chronic infec tion. This has led to marriages breaking down. The risks are unacceptable say campaigners globally. PHOTO: Pexels.
The shocking figures come as a Scottish surgeon this week told BBC Radio that mesh has a: “Whopping 15 per cent of women who develop serious complications.”
Speaking on the Kaye Adams show, Dr Wael Agur said: “No woman should get a life long disability just because of a surgical treatment of urinary incontinence.
“One life ruined is one too many and it’s absolutely unacceptable that a patient will take pain killers for the rest of her life.”
Instead, he said surgeons should move back to two alternative, time honoured surgical fixes, with risks which are acceptable.
The mesh implant scandal was featured on the BBC Victoria Derbyshire show in April. Seen here interviewing reporter Kath Sansom, Claire Cooper and Kate Langley.
Campaigners globally say pelvic mesh risk, quoted in all countries as one to three per cent, is vastly under estimated and based on studies which are either short term, run by medics with conflicts of interest or on animals who cannot speak of the pain or lost sex lives due to intense burning and cheese wire pains in their vaginas.
As the scandal unravels women are calling on governments worldwide to ban mesh implants, used to fix incontinence and prolapse, often caused by pregnancy and childbirth.
Campaigners, Elaine Holmes and Olive McIlroy fought for a suspension on mesh in Scotland in June 2014 but it was re-instated in March 2017 amid claims of a whitewash independent review - now being scrutinised by an independent expert.
Scottish MPs Neil Findlay and Jackson Carlaw have called this a disaster on asbestos proportions.
Leaked document of the English Group Working Party into mesh implants - group members agreed to try to reduce media impact of mesh relating to Yellow Card reporting. Patient reps have not been invited to any meetings for more than a year. PHOTO: Contributed
Welsh MP Owen Smith has called it the worst health scandal he has seen in his time as a politician.
Australian senator Derryn Hinch has said this is the biggest women’s health issue since the morning sickness drug thalidomide.
American lawyer Ben Anderson said: “This is the greatest women’s health crisis of our generation.”
New Zealand politician, Christine Rankin, who suffered agonising mesh implant pain and was told by her surgeon to get used to living with it, said: “Mesh is dangerous and it should be used with caution and the truth needs to be told about it.”
The MHRA commissioned a study into mesh complications. The result is the York Report from 2012.
Problems reported by women globally include leg pain making it difficult to walk far, pain in buttocks and groin making it painful to sit for long, the sharp-edged mesh cutting into tissues, nerves or even busting through vaginal walls, chronic infections and allergic reactions to the plastic material.
Some women are left disabled in wheelchairs and others have to use sticks to help them walk.

Studies with high risk figures include:
An American study which show 42 per cent of women suffer complications - 20 per cent of them serious.
• An Italian study which found risk rate was 30 to 40 per cent.
• An American review which says the risk of pain following a mesh operation is 31 per cent.
• A Canadian study which found problems for 27.9 per cent of women.
A Canadian review that says 22.3 per cent of women risk suffer painful infections.
• A Canadian study discovered poor outcomes for at least 15 per cent of women.
• The FDA say the hooks used to implant mesh can cause damage for up to almost 30 per cent of women.
Almost 20 years after the operation was launched, women say the world must wake up to the fact that mesh implants are not a “gold standard” fix.
Surgeon Firouz Daneshgari, said: “By any modern industrial standards of quality, a 30–40 per cent rate of adverse events is simply unacceptable.
“Can any of us imagine what would happen if one-third of all cars, computers, food packages, or any other commodity we purchase would fail or result in recalls?
“Moreover, it is unlikely that the manufacturer would remain in business after such recalls and failures.”
In the UK, the NHS and MHRA say the benefits outweigh the risk, which they say is as low as one in 100 women.
However, they base their figures on a review called the York Report, carried out in 2012.
Campaigners say the studies in it are flawed as many are short term - as little as six weeks post operation - so do not capture the true picture. Some problems don’t cut in until months or years later.
The UK York Report says the risk of losing or suffering a reduced sex life can be as high as 13.5 per cent while the risk of pain can be as high as six per cent and erosion as high as 5.8 per cent.
However, it averages out its figures of risk to just one to three per cent - a figure quoted in most UK patient information leaflets.
Sling The Mesh campaigner Ann Boni said: “How bad has this got to be before the authorities admit mesh has lifelong disabling risks?”
If a woman suffers complications, then removal is major surgery, Mrs Boni added, but said many surgeons push women to only have part of the mesh tape taken out.
A partial removal takes around half an hour while a full removal can take up to two hours - making it clear that partials are preferred on a cost basis.
A survey carried out by patient support group, Sling The Mesh, found that a full removal can relieve symptoms for almost six out of ten women - 57.14 per cent.
A partial removal, however, left only two out of ten women - 21 per cent - feeling like it had improved things.
Mrs Boni said: “Mesh is designed as a permanent implant and was launched onto the market without the benefit of robust, quality clinical trials. “No thought was given to how it was going to be removed when complications arose.
“It is easier to perform a partial removal but what must be impressed on surgeons is that if women seek removals they must be given full removals because at least the patient stands a chance of getting some quality of life back.
“Partial removals can leave women worse off months or years down the line as mesh continues to shrink, migrate into pelvic organs, harbour infection and the foreign body reaction continues to activate an adverse immune response”
“Surgeons know that if there are problems it is very difficult to fix. So why do they still implant it?”
• A study called Prospect said more than one in ten women suffer complications following a prolapse mesh operation.

• A study, which includes UK mesh removal specialist Suzy Elneil as author, says there should be a red card system for new medical devices. It also says not all women should be considered for mesh as previous pelvic or lower abdominal surgery may mean adhesions. Also some women may have a congenitally distorted pelvis or been traumatised by other causes such as childbirth.

Friday, June 2, 2017

27% Device Failure Rate: Johnson & Johnson DePuy Pinnacle

June 1, 2017
VIENNA — Patients treated at a single center with one brand of metal-on-metal total hip replacement had a statistically significantly greater risk of implant failure if they had bilateral surgery or were operated on in 2006 or later, according to the 10-year results Gulraj S. Matharu, BSc (Hons), MBChB, MRCS, of Oxford, United Kingdom, presented 31 May, at the 18th EFORT Annual Congress in Vienna.

The 569 patients studied retrospectively had standard demographics, he said. They underwent THR with the Pinnacle prosthesis (DePuy Synthes) with a 36-mm cobalt chrome head and an uncemented Corail stem (DePuy Synthes).

Gulraj S. Matharu

“This large cohort study of Pinnacle metal-on-metal (MoM) [total hip replacements] THRs has confirmed a high failure rate at 10 years with this device, but it is especially seen if the Pinnacle was put in from 2006 onwards and in bilateral MoM hip patients. This supports the recent and serious concerns about potential manufacturing differences in more recent years,” Matharu said.
Some of those problems led to edge loading and/or high friction, he noted.
In the first 4 years of the implantations, “there was no significant difference in failure rate between the early and late implantations,” Matharu said.
“Seventeen percent of our cohort were failures, the majority of these being for [adverse reaction to metal debris] ARMD, which is unsurprising,” he said, noting 72 patients (12.7%) had a failed THR due to ARMD. – by Susan Rapp


Matharu GS, et al. Paper #710. Presented at: 18th EFORT Annual Congress: 31 May - 2 June 2017, Vienna.

Disclosure: Matharu reports no relevant financial disclosures.