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.
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Twitter: JjrkCh

Thursday, March 16, 2017

By Lucy Adams FiDA highlight
Political correspondent, BBC Scotland
  • March 15, 2017

An expert at the centre of the independent review group looking at the safety of mesh implants in Scotland has resigned.
The consultant, who does not wish to be named, stepped down following the revelation that an entire chapter of the final report had been removed.
It follows the resignation of two patient representatives who claimed the report had been watered down.
Health Secretary Shona Robison said no evidence would be hidden.
Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants but some have suffered painful and debilitating complications.
There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.
In 2014 former health secretary Alex Neil called for the suspension of such procedures, and an independent review group was set up to look at safety issues.


Patients representatives Olive McIlroy and Elaine Holmes have already resigned from the review group
An interim report published in October 2015 did not advocate a blanket ban on mesh implants but noted that some women do experience serious complications and it made suggestions for reducing the risks. The final report is expected shortly.
Earlier this month, the BBC revealed that an expert member of the review group had written to its chairwoman, raising concerns about the final draft.
The letter states that an entire chapter, which highlighted concerns about the use of mesh in some procedures and contained tables displaying the risks of treatment, had been taken out.
Patients representatives Olive McIlroy and Elaine Holmes, who have both suffered complications as a result of such surgery, resigned from the review earlier this month, claiming that the final report now lacked integrity and independence.


Responding to the latest resignation, Health Secretary Shona Robison said clinical experts sometimes disagreed on complex medical matters.
She said: "I want to reassure the Scottish Mesh Survivors Group their views have been heard, and I want them to remain at the centre of the crucial work.
"I have been clear that all evidence must be made publicly available alongside the report once published. The chair of the Review Group has stressed to me the evidence has been fully considered by the review and none has been hidden.
"This is a complex, technical area and on occasions professionals will disagree. I am aware of the resignation of a clinical member from the group and, while this is unfortunate, their views and contribution to the review is much-appreciated and have proven valuable."
Ms Robision is due to meet Olive McIlroy and Elaine Holmes later this week to discuss their concerns.
In December, the BBC revealed that hundreds of mesh implant operations had been performed in Scotland despite ministers recommending their suspension.
Figures obtained by the BBC revealed that 404 women had received mesh and tape implants since the health secretary called for the suspension in June 2014.

http://www.bbc.com/news/uk-scotland-39279028?SThisFB

Wednesday, March 15, 2017

Pelvic Surgical Mesh Scandal: FDA Wrongly Cleared Predicate Device



Dr Peter Petros said he warned women about the 'very frightening' symptoms of his procedure 

Joanne McCarthy  FiDA highlight

15 Mar 2017, 5 a.m.
A DOCTOR whose invention is at the centre of a global medical scandal told a court in 2004 that women could experience “very frightening” symptoms after a pelvic surgical procedure he developed, but that was “how the operation works”.

“Even though it’s not harmful to the patient it can be quite frightening, that suddenly they get this thick yellow discharge that can be very smelly and it can be very frightening to a patient. So I make sure that I tell them about it,” Dr Peter Petros told a Western Australian court after a woman took civil action against him following mesh surgery using nylon tape.

Judge Roger Macknay awarded the woman more than $136,000 after finding Dr Petros “undoubtedly” failed to warn her of risks associated with Dr Petros’s intravaginal slingplasty (IVS) procedure, based on his “integral theory” to treat urinary incontinence.

The woman, 45 when she had the surgery in 1997, suffered “significant” injury which had a “substantial” effect on her life, with symptoms continuing over the long term, Judge Macknay found.

Dr Petros’s mesh delivery device through a woman’s vagina, the IVS tunneller, which was later developed by a subsidiary of Tyco Healthcare and incorrectly cleared for use in America in 2001 for both urinary incontinence and prolapse in women after childbirth, became the “predicate case” which major medical device companies used to “clear” and market multiple other pelvic mesh devices for prolapse.


Investigation: Dr Peter Petros

Global legal cases brought by women alleging serious injuries after pelvic mesh surgery are estimated to cost $20 billion.

In a paper in 2012 Dr Petros distanced himself from the global mesh scandal, saying his “early experimental studies” had been “wrongly” used as “an intellectual cornerstone to justify the use of mesh in prolapse surgery”.

During the 2004 Western Australian court case Dr Petros denied being “somewhat blinded” to possible risks associated with his (IVS) surgical procedure.

“Can you accept as a possibility that because of your personal and financial stake in this procedure that you may perhaps be somewhat blinded as to the adverse elements associated with it? You see it as your baby and you can’t see any bad elements?” the woman’s barrister, Geoffrey Hancy, put to Dr Petros.

Dr Petros replied: “Absolutely not. The role of the scientist is to seek the truth, whether it’s good or bad. That’s the way it is.”


The court was told Dr Petros received a royalty of about $15 per instrument for the IVS tunneller and he performed about 400 operations a year. 

Judge Macknay found Dr Petros had “a proprietary attitude towards the IVS procedure, as well as great pride in events associated with its development”.

In his dealings with the woman Dr Petros “was concerned to extol what he perceived to be the many advantages of the IVS procedure rather than to point out, in a balanced and neutral manner, both possible beneficial and adverse outcomes and the risks”.

“The defendant did not, it would seem, and apparently still does not, believe there was or is any real detriment associated with ‘his’ procedure,” Judge Macknay said.

Dr Petros “lacked to some extent a complete understanding of the obligation owed by a medical practitioner to a patient who was contemplating surgery”, and was “at times argumentative, anxious to debate, unwilling to answer questions as put, anxious to display his knowledge”, the judge found.

Specialists who gave evidence said the IVS procedure had no independent studies to support it in 1997 and the majority of specialists who performed surgery to treat incontinence did not use the procedure.

By 2003 Newcastle obstetrician/gynaecologist Dr Alan Hewson and his Brisbane colleague Dr Chris Maher said the IVS procedure “cannot be recommended” after treating women dealing with complications after its use, and because of the lack of independent evidence of its safety and efficacy.    

Dr Petros’s name no longer appears on the Australian Health Practitioner Regulation Agency register. He did not respond to questions from the Newcastle Herald about whether he had retired in November. 

The NSW Health Care Complaints Commission advised the Herald it has finalised an investigation of complaints against him and has referred the case to “the Director of Proceedings for the consideration of appropriate disciplinary action”.

http://www.theherald.com.au/story/4524242/doctor-denies-being-blind-to-mesh-risk/?cs=305






Tuesday, March 14, 2017

Australian Pelvic Surgical Mesh Scandal Widens




Difficulty issues remain about mesh surgery for women.

JOANNE McCARTHY  FiDA Highlight

13 Mar 2016, 4 p.m.
THE woman on the end of the phone line said hello and gave her name, and then the sobbing started. For at least a minute she tried to talk but the sobbing overwhelmed her. She regained some control and apologised: “I’m sorry, I’m so sorry, I’ve just had no one to talk to”.

Then the sobbing resumed as she gasped: “I’m rotting from the inside.”


The woman is in her 50s. In 2012 she had surgery to treat prolapse – where a woman’s uterus bulges into the vagina, typically after pregnancy – and her gynaecologist, who has worked in the Hunter, the Central Coast, Sydney and other parts of NSW, spoke about the benefits of using mesh as an internal sling to pull her organs back into place.

He recommended “natural” mesh made of pig intestines, and surgery through the vagina rather than the abdomen.

In a paper for other doctors in 2007 the gynaecologist praised the “natural” mesh over earlier biological prolapse treatments which, he said, women’s immune systems came to regard as “dead tissue” subject to “a strong foreign body reaction”.

In the 2007 paper the doctor declared a conflict of interest – he was being funded by the pig intestine mesh manufacturer to conduct a trial of the mesh’s use in women’s bodies.

The woman said she knew nothing of that.

The pain after surgery started immediately. It worsened with time. Then the “horrible smell” started, the rounds of antibiotics to treat infections, and comments from the gynaecologist that it was “just the healing process”.

After nine months she had a nervous breakdown.

In chronic pain, unable to have sex, isolated, emotionally shattered and coming to terms with the shocking knowledge there was little surgically that could be done to relieve the pain or remove the mesh, she hinted at suicidal thoughts.

I felt like I was treated like a guinea pig,” she said, and sobbed.

“Why is this allowed to happen?”

It only made it worse to hear there are many other women like her.

What has become a global mesh catastrophe for possibly more than 100,000 women who sought prolapse treatment over a decade – which could become one of the biggest medico-legal cases in history - started with a United States Food and Drug Administration (FDA) decision in 2001.

The FDA approved a prolapse mesh device for surgery through a woman’s vagina based on it being “substantially equivalent” to an existing device for surgical incontinence treatment.

Any differences between the devices “do not raise new questions of safety and efficacy”, the FDA stated, so a new prolapse mesh kit device was approved without the rigorous pre-market testing required of new devices or Class III high risk devices. 

The decision, which provided a treatment option for gynaecologists in a difficult area where up to 50 per cent of women seek help for prolapse and incontinence problems over their lifetimes, and up to 19 per cent of American women receive surgical treatment, opened a door and manufacturers responded.

Within a few years up to 40 companies had more than 60 surgical mesh kits for prolapse patients on the American market stating they were “substantially equivalent” to other mesh products, and all reliant on the 2001 FDA approval. They included biological or “natural” mesh products as well as polypropylene plastic devices for vaginal access, or transvaginal, surgery.

By 2012 there were 47 prolapse and incontinence devices on the Australian market.

The only problem was the FDA’s decision process was flawed, said leading Australian urogynaecologist and Queensland University Associate Professor Chris Maher in a paper in 2013 headed The Transvaginal Mesh Decade.

The device approved in 2001 was subject to high complication and infection rates when used to treat prolapse, and was modified and gained a new clearance seven years later.

But the genie was out of the bottle.

The first mesh kits with tools to insert the mesh through incisions in a woman’s vagina were on the market in America in 2004. By 2010 more than 300,000 mesh kits a year were being used for prolapse surgery.

But by that stage adverse event reports were also being logged, with a five-fold increase in adverse reports to the FDA between 2005-2007 and 2008-2010.

The adverse events included mesh erosion and extrusion into the vagina and urinary tract, bleeding and infections, organ perforation, severe and chronic pain, nerve entrapment and urinary problems.

By 2013 a Newcastle specialist complained to the Australian Therapeutic Goods Administration (TGA) about the lack of “rigorous constraints” controlling new medical devices, when compared to drugs, after a woman nearly died of excessive blood loss linked to mesh implant surgery.

The specialist warned the TGA an approved suture device was unsafe after a woman suffered a severe haemorrhage during a trial. The woman complained to the Health Care Complaints Commission about the specialist, saying the operation “went dramatically wrong”.

In his paper Associate Professor Maher outlined how mesh devices remained on the market for a decade, with sometimes catastrophic results for many women.

“These products were aggressively marketed to clinicians by the manufacturers on the basis of FDA clearance,” he said.

Manufacturers, and not Australian, British and American colleges of obstetrics and gynaecology, trained doctors to use the new mesh products to treat prolapse.

It was not until 2011, after thousands of adverse event reports and the start of serious litigation by patients, that the FDA determined serious adverse events with mesh were “not rare”, and could be “life-altering” for some women.

In October 2012 the Australian TGA website noted it had only received 63 adverse event notices, the majority from device manufacturers, despite many thousands of devices being implanted.

The TGA met with the Urogynaecological Society of Australia where the society reinforced its view “the issues were about the use of these meshes  rather than the meshes themselves”.

In his paper Associate Professor Maher noted at least three members of an international gynaecological association that commented about prolapse mesh devices after the 2011 FDA statement received royalties from device manufacturers.

By January 2014 the FDA warned manufacturers it proposed to upgrade mesh products for vaginal-entry prolapse surgery to Class III high risk category, requiring manufacturers to provide clinical data supporting device safety, and post-surgical data demonstrating safety and efficacy.

But by that stage civil suits in the US – and the threat of many more to come – coincided with manufacturers withdrawing devices from the market.

In a significant case American woman Linda Gross was awarded $11.1 million against Johnson & Johnson after prolapse mesh surgery in February 2013 led to 18 subsequent operations. An appeal by the company is currently being heard in the New Jersey Appeals Court.

Mesh activist Jane Akre said more than 100,000 women had filed lawsuits against companies, with Philadelphia woman Patricia Hammons, 65, the most recent successful mesh device plaintiff who was awarded $12.5 million against a Johnson & Johnson subsidiary in December.

Akre said device manufacturers, doctors and regulators had catastrophically failed many women.

Devices entering the market without the clinical assessment required for drugs meant “patients became the post-market clinical trial subjects and many suffered devastating and permanent injuries”.

“The woman at the other end of the pelvis was not even thought of,” Akre said.

Transvaginal mesh legal suits are expected to reach more than $20 billion.

In an internationally-respected Cochrane Review of studies of mesh devices in February, Associate Professor Maher found the quality of evidence ranged from very low to moderate.

In a Cochrane editorial in February titled No implementation without evaluation: the case of mesh in vaginal prolapse surgery, University of Auckland Professor of Obstetrics and Gynaecology Cindy Farquhar said the transvaginal mesh decade was a warning to doctors who had to “learn from the lessons of the mesh experience”.

“New interventions should always be subject to rigorous evaluation through randomised controlled trials, and adoption of new interventions must be accompanied by specific training in their use. Future studies should report adverse events carefully and include reporting pain and quality of life. Our patients deserve better studies and, in the absence of evidence, better advice.”

Port Stephens MP, health lawyer and member of NSW Parliament’s committee on the Health Care Complaints Commission, Kate Washington, said the mesh debacle was consistent with “the dismissive nature of the medical fraternity to women who’ve had significant injury following birth”, including many who suffered with prolapse.

“This dismissive attitude to what are really serious problems for women is really embedded in the medical profession.”

The low number of formal complaints from women to Australia’s Therapeutic Goods Administration about mesh devices was not surprising, she said.

“This is a hidden issue. The women involved are vulnerable, embarrassed and mortified by what’s happened to them in terms of the injuries they’ve sustained, and the fact that it’s hidden has allowed practices like this to flourish.”

Associate Professor Maher said while regulators in Australia and America had failed to monitor and influence clinician behaviour relating to transvaginal mesh, litigation lawyers and publicity had brought about change.

“This scenario is completely unsatisfactory for all pelvic floor clinicians who have failed to demand a satisfactory level of evidence regarding the safety and efficacy of a product prior to its utilization,” he said.

“It is vital that we review the events that allowed the women we are trained to serve to be exposed to unknown risk during the surgical treatment of prolapse.”


In 2012 in response to rising concerns about mesh the Australian TGA said it was not possible to know “all the possible complications that may develop” when a new medical device is approved for use.
http://www.theherald.com.au/story/3778936/women-pay-the-price-for-a-most-private-medical-disaster/
http://bit.ly/2nC4LQF

Friday, March 10, 2017

4/27/2017 ACTION: Johnson & Johnson Annual Shareholders Meeting











Who: Device and Drug Harmed Patients/Advocates:  

Pelvic Surgical Mesh, Breast Implants, Hernia Mesh, Power Morcellators, Hip Replacements  Risperdal, Levaquin,  Motrin, etc.

What: MAM Rally & Patient Safety Peaceful Protest with Award-winning Documentary Filmmaker
When:  Thursday, April 27th 2017, 8 am - 1pm EDT
Where: J&J Headquarters
1 Johnson and Johnson Plaza (Intersection of Albany & Neilson)
New Brunswick, NJ  08901-1241

RSVP to organizers on the official Facebook Event Page:  https://www.facebook.com/events/1190677214382644/

Meet & Greet
Wednesday Evening, April 26th, 6pm
Carrabba's Italian Grill
335 NJ-18, East Brunswick, NJ 08816
(732) 432-8054


Video of 2014 action:  

https://vimeo.com/92990332

What the shareholders are told: http://www.investor.jnj.com/events.cfm

$1Billion verdict J&J DePuy Pinnacle metal-on-metal hips (December 2016)
https://www.law360.com/articles/867121/3rd-j-j-hip-implant-bellwether-delivers-1b-verdict
$2 Billion settlement - Risperdal (2013)
http://articles.latimes.com/2013/nov/04/science/la-sci-drugmaker-settlement-antipsychotic-20131104
Levaquin antibiotic  http://www.fiercepharma.com/regulatory/levaquin-users-slap-j-j-800m-rico-suit-claiming-pharma-giant-hid-serious-side-effects
https://www.drugwatch.com/manufacturer/johnson-and-johnson/

Research must be carried on, innovative programs developed and mistakes paid for. 
The Johnson & Johnson credo

Hotel:  
Holiday Inn Express & Suites Tower Center New Brunswick
4 Tower Center Blvd
East Brunswick, New Jersey 08816

800-315-2621 or 732.247.6800
www.ihg.com/holidayinnexpress/hotels/us/en/east-brunswick/ebknj/hoteldetail

$99 discount rate - code: MAM(complimentary breakfast is included)


Airport:  

Newark (airport code EWR)
20 miles from hotel
or
LGA(LaGuardia airport) via hired car to NYC Penn Station/Manhattan to NJTransit/New Brunswick Station $14/1 hour

Contributions:

Encourage your supporters to participate financially:
GoFundMe to help with expenses and to help pay for hotel costs for those in need.  
https://www.gofundme.com/jj-mesh-rally-fund






































Thursday, December 1, 2016

Convicted Corporate Criminal Johnson & Johnson (Acclarent) kicks employees under jail-time bus.


By Editor Filed in News November 30th, 2016 @ 10:21 am  Corporate Crime Reporter
In July, the former CEO and the former VP of sales of Johnson & Johnson unit Acclarent, Inc., a medical device company, were convicted by a federal jury in Boston in connection with distributing adulterated and misbranded medical devices.

Melayna Lokosky
In the same month, the company paid $18 million to resolve allegations that the company caused health care providers to submit false claims to Medicare and other federal healthcare programs by marketing its sinus spacer product for use as a drug delivery device without U.S. Food and Drug Administration (FDA) approval of that use.
Behind both cases – Melayna Lokosky – a former sales rep for the company.
She blew the whistle on the wrongdoing that led to the $18 million recovery and the criminal prosecutions.
Now she is on a campaign against what she calls the sociopathic business model.
Lokosky was a sales rep for Acclarent and was making $250,000 a year.
In 2011, she decided she would blow the whistle on the company’s fraud.
She laid out the case for the government.
Acclarent sold a variety of medical devices used in sinus surgeries, including a device known as the Relieva Stratus MicroFlow Spacer.
In 2006, Acclarent received FDA clearance to market the Stratus as a spacer to be used only with saline to maintain sinus openings following surgery.
The government alleged that Acclarent intended for the Stratus to be used instead as a drug-delivery device for prescription corticosteroids, including Kenalog-40, and that the device was specifically designed and engineered for this use.
Acclarent marketed the Stratus as a drug delivery device even after the FDA rejected the
company’s 2007 request to expand the approved uses for the Stratus.
Acclarent employees trained physicians using a video that demonstrated the Stratus being used with prescription corticosteroid Kenalog-40 and also used a white, milky substance resembling Kenalog-40 when demonstrating the Stratus.
In 2010, Acclarent added a warning to its label regarding use of active drug substances in the Stratus. The government alleged that Acclarent nonetheless continued to market the Stratus for drug delivery.
By May 2013, Acclarent discontinued all sales of the Stratus and the company agreed to withdraw all FDA marketing clearances for the device, which is no longer commercially available in the United States.
On July 20th, Acclarent’s former Chief Executive Officer, William Facteau, 47, of Atherton, California and former Vice President of Sales, Patrick Fabian, 49, of Lake Elmo, Minnesota were convicted following a six-week jury trial of 10 misdemeanor counts of introducing adulterated and misbranded medical devices into interstate commerce.
As a result of Lokosky’s whistleblowing, the government recovered $18 million. Lokosky’s share — $3.5 million.
“That number is not in my bank account, I can assure you,” Lokosky told Corporate Crime Reporter in an interview last week.
Because of taxes and your lawyer’s fee?
“Correct,” Lokosky said. “Reporters always want to know — what does the whistleblower get? It makes us look like we were greedy. I was making $250,000 a year. I would have made more money if I kept my mouth shut. That’s not why I did this.”
Taxes are 40 percent. The lawyer gets 40 percent. You are down to a couple of years’ salary.
“Less,” she says.”That’s not a complaint. That’s a reality. People should know that if you are going to go forward. The Department of Justice needs to fix it also. You are not talking about pharmaceuticals where you are talking about a billion dollars in damages. It’s not there. The Department of Justice says you are awarded that. That’s bullshit. I earned every penny of that. I was without a job for over three years.”
Facteau and Fabian were convicted at trial.
What was their sentence?
“They haven’t been sentenced yet. That comes January 11, 2017 in Boston.”
Did you know them?
“Yes. I worked with them.”
Did you testify against them?
“I could not because I was the whistleblower. I was in the courtroom every day with the exception of two days for six weeks.”
You were staring them down?
“It was mainly to see that what was being said was accurate. I don’t have an axe to grind with them. They are puppets. They got pinched. They didn’t have enough information to flip on higher ups. That is what happened.”
Was there a criminal case brought against a company?
“No. That’s the other thing wrong with the process. Once you file a whistleblower complaint, it goes behind closed doors. All of those I worked with at the Department of Justice and the FBI worked their asses off to get this done. And then it goes to DC and a settlement is decided on behind closed doors with Covington & Burling — Johnson & Johnson’s attorney — and the Department of Justice. And of course, the lawyers walk from the Department of Justice to Covington for a job afterwards.”
Who was the attorney for Johnson & Johnson?
“Ethan Posner. How many corporate integrity agreements does the company get to sign before the government realizes that the company has no integrity?”
What is your current work?
“I’m starting a consulting company. I’m consulting with companies about how to become more profitable and do it ethically.”
You have created something called the sociopathic business model. What is it?
“It’s a tool or checklist to help people to determine whether or not they are being abused by an institution. Once you see this pattern, you cannot unsee it.”
“Companies are encouraging, replicating and rewarding unethical and illegal behavior and removing those who expose that. The checklist helps people see if you are getting inconsistent and contradictory language to action. Regulatory is telling you one thing. Sales and marketing is telling you another. That’s a trigger for a sociopathic business model.”
“If a company is covering up sexism, retaliation, racism — in 99 percent of the cases it means they are engaged in far greater unethical and illegal activity.”
“This is laid out on my web site — killingmycareer.com. I’m the first whistleblower under seal to start a blog in their own name about their own case without breaking the seal. According to the Department of Justice, I broke the spirit of the seal, but I did not break the seal. They were not happy about my blog. I got called back to the principal’s office in Boston and was told that I needed to take it down. I told them no — I have a First Amendment right. I will not take this down.”
“If the criminals can use the First Amendment, why don’t the people defending this law get to use it?”

[For the complete q/a transcript of the Interview with Melayna Lokosky, see 30 Corporate Crime Reporter 46(12), November 28, 2016, print edition only.]
http://www.corporatecrimereporter.com/news/200/melayna-lokosky-wants-to-take-down-the-sociopathic-business-model/

Sunday, November 27, 2016

UN-Informed Consent & Sales Reps in the Operating Room



By Sandra G. Boodman November 15, 2016

Illustration by Jeannie Phan for The Washington Post






They are a little-known presence in many operating rooms, offering technical expertise to surgeons installing new knees, implanting cardiac defibrillators or performing delicate spine surgery.
Often called device reps — or by the more cumbersome and less transparent moniker “health-care industry representatives” — these salespeople are employed by the companies that make medical devices: Stryker, Johnson & Johnson and Medtronic, to name a few. Their presence in the OR, particularly common in orthopedics and neurosurgery, is part of the equipment packages that hospitals typically buy.
Many “people who don’t work in health care don’t realize that industry reps are sometimes in the OR,” said Josephine Wergin, a risk management analyst for the ECRI Institute, a Pennsylvania nonprofit that conducts research on medical subjects for the health care industry. “A lot of times they are the real experts on their products.”
Unlike rotating teams of nurses and surgical techs, reps are a consistent presence, experts say, often functioning as uber-assistants to surgeons with whom they cultivate close relationships and upon whom their six-figure salaries depend.
Although they don’t scrub in, reps are expected to be intimately familiar with the equipment they sell, making sure it is at the ready for the surgeon and poised to answer technical questions.
Who’s The Expert?
But how much influence do reps wield, how necessary and costly are their services and does their presence in the OR, which may not be disclosed to patients, raise ethical questions about informed consent? A string of court cases has raised questions about their involvement in surgeries that went awry, dating back to the late 1970s when a New York sales manager who had not graduated from high school tried for three hours to fix a prosthetic hip while a surgeon allegedly left the OR.

Despite their role, device reps have received little scrutiny, in sharp contrast to drug salespeople, whose role has been the subject of considerable research.
“There’s so little public awareness of this,” said Adriane Fugh-Berman, an associate professor of pharmacology at the Georgetown University School of Medicine and director of PharmedOut, a project that focuses on prescribing and drug-marketing practices. Fugh-Berman is the coauthor of a recent study that raises questions about whether surgeons rely too heavily on reps for technical expertise and assistance, to the potential detriment of patients.
But the cost of medical devices, an industry with about $150 billion in annual U.S. sales, combined with concerns about conflicts of interest by doctors who must report industry payments as part of the Affordable Care Act, has resulted in increased scrutiny, as hospitals from Savannah to Stanford seek to standardize and circumscribe the activities of device salespeople.
Several high-profile lawsuits have played a role, among them a 2006 Ohio case in which a surgeon and a rep were ordered to pay a patient $1.75 million after botched brain surgery. The salesperson had wrongly assured the surgeon that a bone cement was suitable for sealing a hole in the patient’s skull. In 2003, Endovascular Technologies pleaded guilty to 10 felonies in federal court and paid more than $92 million in criminal and civil penalties for covering up problems including 12 deaths associated with an abdominal device. Doctors had been removing the device using a technique devised by reps that had never been approved by the Food and Drug Administration.
Some hospitals, most notably Loma Linda University Medical Center in California, have largely eliminated reps in orthopedics, buying implants directly from the manufacturer at a substantial discount and training surgical technicians to take their place in the OR. Loma Linda’s chief of orthopedics said the hospital has saved about $1 million annually, a savings of about 50 percent on the cost of the devices, without affecting outcomes.
“I think there is a role” for reps, said Lisa McGiffert, director of the Consumer Reports Safe Patient Project. But, she added, when it comes to choosing the best device — such as a prosthetic knee — “can the patient trust that they’re getting the expertise of the doctor or the influence of the rep?”
The presence of device reps in the OR, she added, also raises questions about the adequacy of consent, if patients are not explicitly informed of their presence.
Learning On The Fly
ECRI recently repeated its recommendation that hospitals obtain explicit written consent from patients if reps are to be present and warned surgeons against learning “how to use … devices on the fly.”
How often that happens is unclear, because what happens in the OR tends to stay in the OR. A small 2014 study suggests that reps’ over-involvement is not uncommon.
A survey conducted by researchers at New York’s Albany Medical College found that 88 percent of 43 device reps said they had provided verbal instructions to a doctor during surgery, while 37 percent had participated in a surgery in which they felt their involvement was excessive, often because the surgeon lacked sufficient expertise. Twenty-one percent said they had direct physical contact with hospital staff or a patient during an operation, which could violate hospital policy as well as state law.
Terry Chang, associate general counsel of AdvaMed, a device industry trade association, points to its code of ethics as well as newly revised guidelines issued by the American College of Surgeons, which state that reps are to refrain from medical decision-making and participating in surgery.
But Chang says that reps, who have witnessed dozens if not hundreds of the same procedures, provide an essential benefit for doctors and patients. They “are only present at the behest of the physician and only as a trainer,” and they provide “a live interactive resource.”
Their value, Chang said, lies in their expertise, which can make surgery faster and more efficient. “For a lot of institutions, it’s a bandwidth issue,” he said, echoing a finding in Fugh-Berman’s study that some surgeons prefer working with reps because they are more knowledgeable than hospital staff.
Gerald Williams, a Philadelphia joint replacement specialist who is president of the 18,000-member American Academy of Orthopaedic Surgeons, agrees. “Even if a surgeon is extremely familiar” with a device, “there are different teams scrubbing in” who typically have less familiarity with the procedure and the surgeon’s process than a rep with whom a surgeon regularly works.
“Their presence is dictated by the complexity of the surgery,” he said. “They are probably there close to 100 percent in complicated cases such as spine surgery and joint implants.”
Williams said he doesn’t tell his patients that a rep will be in the room, adding, “I don’t tell them there’s a circulating nurse, either. My patients look at me as being the captain of the ship. I think if I told them about a rep, they would all be supportive of it.”
While salespeople have been in operating rooms for decades, their participation mushroomed beginning in the late 1990s with the proliferation of total joint replacement operations, said Linda Groah, the longtime executive director of AORN, the Association of periOperative Registered Nurses.
These days, “there’s much more control of the reps,” she said. “They just don’t come through willy-nilly.'”
But Jeffrey Bedard’s 2014 study about their role in the OR makes it clear that in some cases, there may be a chasm between guidelines and actual practice.
Bedard, who conducted his research as a graduate student in medical ethics, said it was prompted by his experience as an orthopedic device rep in the late 1990s. He subsequently became a drug salesman and now works in the pharmaceutical industry.
Bedard vividly remembers participating in one case involving a patient in her mid-40s. The surgeon, with whom he had not previously worked, refused all preoperative training, including watching a video, on a new $10,000 hip replacement system. “He said, ‘You’re going to be there, right?'” Bedard remembers being asked.
“To say that the case was a train wreck would be an understatement,” Bedard recalls. The surgeon repeatedly cursed at him and at the circulating nurse, who continually monitors the patient and is responsible for ensuring that the proper equipment is available, as he struggled to perform the procedure. “I had to hold up the illustrated surgical technique and talk him through the case step by step,” Bedard remembered. “I was absolutely beside myself.”
Bedard recalled that when he called his supervisor to report what had happened, “my boss said: ‘You just made $1,000 for three hours’ worth of work. What are you complaining about?'”
Judging by the responses to his anonymous survey, which found that 37 percent of reps said they believed they had been excessively involved in an operation and 40 percent had attended a surgery in which they questioned the surgeon’s competence, Bedard said little appears to have changed. “As a rep,” he said, “you’re paid to sell, to grow your business.”
Two years ago, Gary Botimer, a joint replacement specialist who is chief of orthopedics at Loma Linda, undertook a radical experiment: He got rid of reps in joint replacement cases. Botimer negotiated a steep discount on the price of artificial joints bought in bulk from a well-known American manufacturer and sent hospital surgical techs to the technical training given to device salespeople.
“It took me two years to convince the administration” to do this, recalled Botimer, who said that one surgeon, who had significant financial ties to a manufacturer, quit. “I took a lot of bullets.”
“What we basically did is to take the skill set of the reps and replace it with our own employees, who don’t have a conflict of interest,” Botimer said. “It’s very easy to train your own people. We have found that the techs are better than the reps.”
The ‘Rep-Less Model’
To lay the groundwork, Botimer said he and other surgeons reviewed the literature to select the best implants as the hospital’s standard. After the program was launched in 2014, Botimer said, he and his staff tracked the outcomes of all 500 joint replacement cases for one year to see if the “rep-less model” was equivalent. No difference in outcomes was detected, he said, but the hospital saved $1 million each year. (While standard implants are used in about 90 percent of cases, Loma Linda surgeons are free to use other devices if they believe doing so is in the patient’s best interest.)
The program has been so successful that it is being extended to other orthopedic surgeries, such as trauma and spine operations, he said. Botimer added that he is fielding inquiries from other hospital systems contemplating a similar move.

“This is a big change in the culture, and no one makes that change easily,” he said. “You have operating [room] personnel who’ve only known one way of doing things, doctors who are afraid to try it and administrators worried that docs would turn on them. We’ve spent a couple of years proving to everybody that their worst fears didn’t happen.”
http://khn.org/news/medical-device-employees-are-often-in-the-o-r-raising-concerns-about-influence/