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.
Twitter: JjrkCh

Tuesday, November 4, 2014

Stryker: $1.43 BILLION Settlement Offer (Criminal ?!)

http://www.nytimes.com/2014/11/04/business/stryker-settles-suits-by-hip-implant-patients-for-dollar1-billion.html?emc=edit_tnt_20141103&nlid=50639700&tntemail0=y&_r=0

Stryker Settles Suits by Hip Implant Patients for $1 Billion
By BARRY MEIER NOV. 3, 2014
Stryker, the major producer of artificial hip implants, said on Monday that it had reached a settlement of thousands of patient lawsuits involving now-recalled all-metal devices that is expected to cost the company about $1 billion.
The Stryker deal, negotiated with lawyers representing the patients, would be one of the highest amounts paid in the last year by an implant manufacturer to resolve claims by patients who said they were injured by a hip replacement in which a device’s ball and cup components were both made from metal.
Last November, the DePuy division of Johnson & Johnson agreed to pay about $2.5 billion to resolve lawsuits filed by 8,000 patients who said they were injured by an all-metal implant that it once sold, known as the Articular Surface Replacement or A.S.R.
All-metal implants once accounted for about one of every three devices used in the estimated 250,000 hip replacement procedures that are performed annually in this country. The devices have been largely abandoned after evidence emerged several years ago that the metal components could rub together, creating tiny particles of metallic debris that could severely damage a patient’s tissue and muscle.
In announcing the settlement, Stryker, which is based in Kalamazoo, Mich., said that it covered patients who had received the Rejuvenate Modular-Neck or the ABG II Modular-Neck and who underwent operations to have the implant replaced. Stryker recalled both models in 2012 as complaints increased.
Stryker said that it had set aside $1.45 billion to settle the claims but that it expected the eventual expenses to be higher.
“This settlement program provides patients compensation in a fair, timely and efficient manner,” said William J. Huffnagle, the president of Stryker Orthopaedics.
Since abandoning all-metal implants, surgeons have returned to devices made of a mix of materials, such as plastic and metal.

http://atlanta.legalexaminer.com/defective-dangerous-products/hip-implant-settlement-proposal-announced-on-stryker-rejuvenate-and-abgii-cases/
Hip Implant Settlement Proposal Announced On Stryker Rejuvenate and ABGII Cases
Posted by Richard R. Schlueter
November 3, 2014 4:00 PM



Just over two years since the Stryker Rejuvenate and ABGII hip implant products were recalled from the market in June 2012, national leadership in the multi-district litigation (MDL) today announced a global settlement proposal for all Stryker Rejuvenate and ABGII hip implant victims who have undergone revision surgery to remove and replace their recalled Stryker hip implant on or before November 2, 2014.  The settlement proposal includes a base award amount of $300,000.00 to each claimant who has undergone revision surgery on or before to November 2, 2014, and otherwise qualifies for the settlement. There are certain limited potential reductions to the base award for age, prior hip revisions, and other relevant factors.  Claimants may also receive additional compensation, referred to in the proposed settlement as “Enhancements,” at a later date if they can demonstrate that they meet the eligibility requirements for the categories set forth in the settlement agreement.
Although participation is voluntary, it is expected that many of those that qualify (those who have had their recalled Stryker hip removed and replaced on or before November 2, 2014) will benefit from the settlement program, and may ultimately decide to participate in the settlement.  Any such decision should be made on an individual, case-by-case basis.
The following is a basic summary highlighting key aspects of the Master Settlement Agreement:
Stryker Hip Settlement
The settlement program applies to patients who are U.S. citizens and residents who had either an ABG II Modular Neck System or a Rejuvenate Modular Neck System implanted in their bodies in the United States, and who had a qualified surgery to remove and replace the recalled device on or before November 2, 2014.  The settlement program is also open to certain patients who have been deemed to be too sick or medically unstable to undergo a necessary revision surgery.
At Childers, Schlueter & Smith, our attorneys will immediately undertake to determine how the proposed settlement will affect each of our clients, and will work with each client individually to carefully consider the benefits of the proposed settlement so that they can make an informed personal decision on whether or not to participate.  As a nationally appointed leader in this litigation, founding partner Richard R. Schlueter will ensure each and every one of our clients has all of the information he/she needs to make the best choice for his/her unique situation.   Richard Schlueter has been involved in the various hip implant litigations (including DePuy ASR/Pinnacle, Zimmer Durom Cups, Biomet M2a Magnum and Wright Conserve Plus among many others) for several years, and has unique knowledge relating to hip implant failures and the injuries caused by those failures. Our current and future clients will be continue to be very well represented and informed during the entire process.
Attorneys representing those interested in participating in the Stryker hip implant settlement will have to register their clients in the program on or before the initial reporting deadline of December 14, 2014.  After that, the next deadline will be the formal enrollment of each individual patient who chooses to participate into the Settlement Program.  Those qualified claimants who would like to participate in the settlement program must enroll by March 2, 2015.  If less than 95% of the qualified claimants elect to participate in the settlement, Stryker has the ability to walk away and cancel the settlement program.  Stryker must make that decision on or before June 15, 2015.  Assuming the participation threshold is met and the settlement continues after June 15, 2015, the deadline to file claims for Enhanced benefits is September 30, 2015.  Additional compensation through the Enhanced benefits portion of the settlement will relate to damage to the femur, soft tissue damage, additional procedures and infection.  There is a cap on the Enhanced damages so that most total claims (Base award and Enhanced benefits) will be no more than $550,000.00 per claimant.
Based on the timing of the deadlines in the proposed settlement, it is unlikely that any settlement payments will be made prior to late summer or early fall 2015.
For patients who are not eligible for the settlement program, Stryker’s existing program for reimbursement of eligible out of
pocket costs, administered by Broadspire, remains available.  The decision to undergo a revision surgery is a medical decision, not a legal decision, and should be made only by patients in consultation with their surgeons.  If you were implanted with a recalled Stryker Rejuvenate or ABGII hip implant product but are not eligible for the settlement program, all of your legal rights and claims are preserved and you will not be affected so long as you have a filed legal claim with the Court.  Patients who have been implanted with a recalled Stryker hip in both hips (referred to as “bilateral” hip implants), in whom only one hip has been revised, will retain all of their claims and legal rights in regard to the unrevised hip, even if they participate in the settlement for their revised hip.
Childers, Schlueter & Smith is committed to continue litigating all claims for our clients who don’t qualify, who are arbitrarily penalized so as to not receive an offer under this proposal, who have not had revision surgery by today’s date, and those who choose not to participate in the proposed settlement.  If you have a recalled Stryker Rejuvenate or ABGII, please call us for a free consultation regarding your legal options.
For those looking for answers and guidance on these and/or any other Stryker hip implant related issues, we welcome you to contact our office for more information.


http://abcnews.go.com/Business/wireStory/stryker-pay-143b-settle-hip-implant-cases-26664666

Stryker to Pay $1.43B to Settle Hip Implant Cases
ST. PAUL, Minn. — Nov 3, 2014, 9:04 PM ET

Medical implant maker Stryker will pay at least $1.43 billion to settle thousands of lawsuits from patients who had to have surgery to remove problematic hip implants, under a deal announced Monday.
The agreement, brokered by a New Jersey Superior Court judge, resolves state and federal lawsuits against the maker of orthopedics. It was announced Monday in U.S. District Court in St. Paul, Minnesota.
Stryker said the $1.43 billion figure represents the "low end of the range of probable loss to resolve these matters."
The lawsuits stem from two hip implants that Stryker recalled due to corrosion and other problems in 2012. One year ago Johnson & Johnson paid $2.5 billion to settle 8,000 lawsuits from patients who had to have the company's metal ball-and-socket hip implant removed or replaced.
Plaintiffs in 39 states alleged Kalamazoo-based Stryker sold defective hips that corroded while in patients' bodies and caused illness, including pain and swelling in the tissue around the implant.
"The settlement represents one of the largest medical device settlements with an unlimited compensation fund," said Minneapolis lawyer Charles Zimmerman, who helped negotiate the deal as part of the lead-counsel committee for the case. "We are pleased that we were able to reach a settlement with such meaningful relief."
Stryker Corp. expects to make most of the payments by the end of 2015.
Thousands of cases from patients across the country have been consolidated under a single federal judge in Minnesota in a "multi-district litigation," a common type of mass lawsuit filed against health care companies, the Star Tribune of Minneapolis reported.

Stryker Corp. to pay at least $1.4 billion to settle hip replacement lawsuits

Stryker Corp., whose Kalamazoo headquarters is shown here, has entered an agreement intended to resolve a wave of state and federal lawsuits related to two hip replacement products that it recalled in July of 2012.
Al Jones on November 03, 2014 at 6:39 PM, updated November 03, 2014 at 7:22 PM
KALAMAZOO, MI – Stryker Corp. has agreed to pay at least $1.4 billion to settle thousands of lawsuits by U.S. patients who had surgeries to revise problematic Stryker hip replacements.
The settlement in New Jersey's Bergen County Superior Court is intended to compensate individuals who had to have surgery to replace either of two Stryker products -- the Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem.
Following complaints by patients of pain and swelling that were attributed to fretting and corrosion of the metal-on-metal hip implants, Stryker voluntarily conducted a worldwide recall of the products in July of 2012.
The company did not provide an estimate of how many people may have been effected or how many may be compensated. It also did not offer a representation of how much individuals stand to receive.
"The ultimate cost to entirely resolve these matters will depend on many factors that are difficult to predict and may be materially different than the amounts accrued to date," the company stated in a press release. "Further charges to earnings may need to be recorded in the future as additional information related to patient enrollment in the Settlement Program becomes available."
The company stated that it expects to make the majority of the payments under the settlement agreement by the end of 2015. The agreement, which is intended to resolve a wave of state and federal lawsuits, was brokered by New Jersey Superior Court Judge Brian R. Martinotti with the help of former United States Magistrate Judge Diane M. Welsh, acting as chief mediator.
It covers individuals who have already had surgery to replace the Stryker products. It also covers those who are already party to a lawsuit as well as those who are not.
In a June report, MT Services LLC reported that some cases involving revisions of Stryker Rejuvenate and ABG II hips could be worth more than $500,000.
According to Stryker, patients eligible for compensation should talk with their attorneys, if they have one, or contact the Settlement Program claims administrator at www.strykermodularhipsettlement.com or 1-855-382-6404. Patients do not need an attorney to participate in the Settlement Program.
A program called Broadspire, being done in partnership with third-party claims administrator Broadspire Services Inc., offers support for recall-related care among U.S. patients who have not had surgey to remove the recalled products.
In its press release, Stryker advised those patients to visit http://www.aboutstryker.com/modularneckstems/or call 1-888-317-0200 for more information. It stated that patients do not need an attorney to participate in the Broadspire program.
Kalamazoo-based Stryker produces a wide range of medical technologies including surgical devices, patient-handling devices, hospital beds and orthopedic implants such as replacement hips and joints.

MLive business writer Al Jones may be contacted at ajones5@mlive.com. Follow me on Twitter at ajones5_al.

Thursday, October 30, 2014

Bum Tornier Elbow, Abandoned Patient, Inversion and a $3.3 BILLION Merger/Sale/Deal. Protect those shareholders! Follow the Money!

FiDA highlight
Just a reminder:  Doug Kohrs, the former CEO of AMS, American Medical Systems/Endo Pharmaceuticals now from Dublin, Ireland (producer of FAILED pelvic surgical mesh) and CEO of Tornier-a Minnesota company-now from the Netherlands-that made the elbow that failed in my brother after just 4 months-left abruptly and gave himself $2.6M when the company was failing to bring in a profit.



Oct 28, 2014, 1:17pm CDT
Staff reporter-
Minneapolis / St. Paul Business Journal


Orthopedic-device maker Tornier has been sold to Wright Medical Group Inc. in an all-stock deal worth $3.3 billion, the companies announced Monday.
Memphis-based Wright Medical Group, which makes surgical devices and bone-growth products, will own 52 percent of the combined company's stock when the deal closes.
The combined company will operate as Wright Medical and be led by Robert Palmisano, Wright's president and CEO. Tornier CEO David Mowry will serve as president and chief operating officer.
Tornier is based in the Netherlands, but its U.S. headquarters and top executives are based in Bloomington. The business ranks as Minnesota's 10th-largest medical-technology company, according to Business Journal research.
Tornier's Bloomington office will serve as the U.S. headquarters for the combined company's upper extremity business unit, Tornier said in a regulatory filing. Wright's U.S. headquarters and executive team will be based in Memphis. Its global headquarters will be based in the Netherlands.

Tornier makes devices for the treating orthopedic problems in shoulders, hand, elbows and other extremities. The company generated $311 million in revenue last year. Wright's sales totaled $242 million in 2013.
___________________________________________________



October 27, 2014 | By Varun Saxena
Wright Medical Group ($WMGI) plans to merge with peer Tornier ($TRNX) in an all-stock transaction designed to create a pure-play orthopedics extremities and biologics company valued at $3.3 billion. The resulting entity is expected to be a midsized growth company that's in what it says are the three fastest growing areas of orthopedics--upper extremities, lower extremities and biologics.
The newly combined company will be incorporated in the Netherlands, where Tornier is currently headquartered. The inversion deal is one of the first since release of the Treasury Department's rules to deter the tax-saving practice. One of them was a med tech deal between hospital products and services companies Steris and U.K.-based Synergy Health.
During the conference call describing the deal, company officials said the short-term tax advantages will be minimal, according to the Wall Street Journal.
The deal values Tornier at a premium of 28% over its Oct. 24 closing price. Wright shares climbed 6% to $33.50 in after-hours trading on the news, while Tornier gained 31% to $31.44. Each share of Wright common stock will be exchanged for 1.0309 ordinary shares of Tornier.
"Together, we will have one of the most comprehensive upper and lower extremity product portfolios in the market, extending our leadership position and further accelerating our growth opportunities and path to profitability, all of which we believe will generate long-term value for our shareholders. In addition, this will provide our employees with opportunities for career growth and development as part of a much larger, dynamic organization," Robert Palmisano, CEO of Wright Medical, said in a statement.
He will become CEO of the newly combined company, to be known as Wright Medical Group N.V. The U.S. headquarters for the Lower Extremity and Biologics businesses will be in Memphis, TN, where Wright is currently headquartered. The U.S. headquarters for the Upper Extremity business will be based in Bloomington, MN, at an existing Tornier facility. Wright shareholders will own 52% of the new company and Tornier shareholders, 48%.
"Both companies have built a deep and loyal customer base and have highly complementary product portfolios, positioning the combined entity to deliver meaningful value to our shareholders. We believe that partnered together, Wright and Tornier will become the fastest-growing company in the Extremities-Biologics industry," said Tornier CEO David Mowry, who will become COO of Wright Medical Group N.V.
The news comes on the same day as Wright's announcement that it received PMA approval from the FDA for its Augment Bone Graft as an alternative to autograft for ankle and/or hindfoot fusion indications.
Both companies make implants to fix or replace the wrist and ankle as well as biologics to encourage healing and tissue regeneration. Tornier's U.S. portfolio also includes implants for the shoulder and elbow, as well as surgical tools enabling sports medicine.
The new company is expected to have revenues growing in the mid-teens with adjusted EBITDA margins approaching 20% in three to four years. Cost synergies are expected to be in the range of $40 million to $45 million within the first three years after the transaction completes; synergies will be due to overlapping public company expenses, support function and system costs as well as process and vendor consolidation. Wright expects the transaction will be accretive to the new company's adjusted EBITDA in the second full year after the transaction completes.
Separately, Tornier reported Q3 revenues were up 14.9% year over year to $76.7 million. Meanwhile, Wright's quarterly net sales of $71.3 million were up 24%. The transaction is expected to close during the first half of 2015.
- read the release
- here's the Wall Street Journal article (sub. req.)
Editor's Note: This article has been updated to indicate that the transaction involves tax inversion.
___________________________________________________________________



New Company Will Be Based in Tornier’s Current Home of the Netherlands
By LAUREN POLLOCK  Wall Street Journal
Updated Oct. 27, 2014 6:20 p.m. ET

Medical-device companies Wright Medical Group Inc. and Tornier NV agreed to combine in an all-stock deal that would move Wright’s headquarters to the Netherlands.
The companies, which both make orthopaedic devices, said their combined equity value is about $3.3 billion. Wright shareholders will own about 52% of the combined company, while Tornier investors will have 48%.
This deal follows other acquisitions prompted in part by potential tax advantages, known as inversion deals. In recent weeks, the Obama administration has moved to stem that wave of corporate inversions by unveiling new tax rules.
On a conference call, the companies downplayed the tax implications of the deal, saying the near-term advantages are minimal.
The combined company will be called Wright Medical Group NV and will be led by Wright’s current CEO, Robert Palmisano, but it will be based in the Netherlands, with a U.S. home at Wright’s current Memphis base.
Tornier CEO David Mowry will be chief operating officer of the combined company. The board will be made up of five representatives from each company’s existing board.
Wright makes extremity and surgical tools, while Tornier makes tools for surgeons who treat musculoskeletal injuries and disorders of the shoulder, elbow, wrist, hand, ankle and foot.
Write to Lauren Pollock at lauren.pollock@wsj.com
_______________________________________________


SHAREHOLDER ALERT: Law Firm of Levi & Korsinsky, LLP Launches Investigation Against the Board of Directors of Wright Medical Group, Inc. Regarding the Fairness of the Sale of the Company to Tornier NV
Published: October 29, 2014
NEW YORK--(BUSINESS WIRE)--Oct. 29, 2014-- Levi & Korsinsky is investigating the Board of Directors of Wright Medical Group, Inc. (“Wright Medical” or “the Company”) (NasdaqGS: WMGI) for possible breaches of fiduciary duty and other violations of state law in connection with the sale of the Company to Tornier NV.
Click here to learn more about the investigation: http://zlk.9nl.com/wright-medical-wmgi.
Under the terms of the transaction, Wright Medical shareholders will receive 1.0309 Tornier common shares for each share of Wright Medical stock they own, representing an approximate value of $24.79 per share, based on Tornier’s recent closing price. The investigation concerns whether the Board of Wright Medical breached their fiduciary duties to stockholders by failing to adequately shop the Company before agreeing to enter into this transaction, and whether Tornier NV is underpaying for Wright Medical shares. In particular, at least one analyst has set a price target for Wright stock at $40 per share.
If you own Wright Medical common stock and wish to obtain additional information, please contact Joseph E. Levi, Esq. either via email at jlevi@zlk.com or by telephone at (212) 363-7500, toll-free: (877) 363-5972, or visit http://zlk.9nl.com/wright-medical-wmgi.
Levi & Korsinsky is a national firm with offices in New York, New Jersey, Connecticut and Washington D.C. The firm’s attorneys have extensive expertise in prosecuting securities litigation involving financial fraud, representing investors throughout the nation in securities and shareholder lawsuits. For more information, please feel free to contact any of the attorneys listed below. Attorney advertising. Prior results do not guarantee similar outcomes.
Source: Levi & Korsinsky
Levi & Korsinsky, LLP
Joseph Levi, Esq., 212-363-7500
or
Eduard Korsinsky, Esq., 212-363-7500
30 Broad Street - 24th Floor
New York, NY 10004
Toll Free: (877) 363-5972
Fax: (866) 367-6510
www.zlk.com

Friday, October 10, 2014

"PROVE IT !!!" M-o-M hips, pelvic surgical mesh, Essure birth control . . .


Posted: October 8, 2014 - 3:15 pm ET

“Prove it.” That was the resounding message to medical-device manufacturers during the annual Advanced Medical Technology Association conference in Chicago this week. Innovation is needed to advance medicine and better patients' quality of life, but gone are the days of sticking higher price tags on products that only provide incremental improvements, the leaders of health insurance companies, health systems, quality improvement and consumer organizations told the industry.

“We don't want to squelch innovation,” said Dr. Scott Josephs, national medical officer for the health insurance provider Cigna Corp. “But tell me what I'm getting for my healthcare costs. Show me that these new technologies are superior,” he told the audience during a session Wednesday morning.


Related Content


Josephs was joined on the panel by Susan DeVore, president and CEO of the health improvement organization and group purchasing organization Premier; and Mark Neaman, CEO of the Chicago area's NorthShore University HealthSystem. An essential element in the aim for higher efficiency will be the need to more critically assess the value of new innovations, the panelists said.

“If it's clinically appropriate but equally efficacious to existing technology, then frankly it's just adding costs to the system,” Josephs said. “That's not something we would prefer.”

Fee for service is dead and the current landscape “is a bit chaotic,” noted DeVore, who said health providers are in the process of integrating what has been a fragmented industry. In light of that, the old ways of doing things are not going to suffice, Neaman said. “The stakes are very high for us as providers,” he told the audience.

New payment models aimed at improving efficiency and getting a handle on costs have proliferated quickly in recent years, nurtured by provisions of the Patient Protection and Affordable Care Act. Many providers are joining accountable care organizations, which are risk-sharing mechanisms available through government payers like Medicare as well as private payers, in which members agree to strive for cost and quality targets and share savings or losses.

Monday, AdvaMed promoted an industry-funded white paper based on the responses of officials from nine unnamed health insurance companies who were interviewed about their movement toward pay-for-performance and risk-based contracts. Officials from five insurers said they had become more selective about approving coverage for new technologies in the past three years. Four said they plan to demand more evidence before covering products. All said costs were driving their organizations to explore new reimbursement models.

The trade group representing medical-device manufacturers worried these rapidly burgeoning pay-for-performance and risk-based reimbursement models will result in what AdvaMed CEO Stephen Ubl called “unintended consequences.”

Too many of the arrangements emphasize cost targets over quality benchmarks, said Joe Almeida, the trade group's chairman as well as CEO of the medical-device manufacturer Covidien. “They run the risk of really tipping too far, so physicians have incentive not to adopt things that really benefit patients,” said David Nexon, an AdvaMed senior vice president.

Health economists countered that the white paper may have overstated those concerns and that it's hard to make the extrapolation. Insurers agreed, saying truly superior innovations would not be overlooked, even if they come at higher costs. And most health officials interviewed by Modern Healthcare said the key factor is the proof.

“The thing that's been missing from the model until now is the evidence,” said Diana Zuckerman, a researcher who has been critical of the Food and Drug Administration's procedures for approving and monitoring medical devices.

The federal agency's recent plans for an accelerated approval pathway for some medical devices has been met with criticism by consumer advocates who say such efforts put patients in danger.

During a conference session on Tuesday afternoon, FDA Commissioner Dr. Margaret Hamburg said that as science and technology advance at extraordinary rates, the agency wants to stay up to speed as a partner with the medical technology community. A more efficient system overall will allow for the delivery of new science and technology for patients in more reliable and cost-effective ways, but the emphasis on speed doesn't mean a step away from scientific rigor, she said.

As new products make their way to the forefront, no matter how rapidly, the onus is increasing for manufacturers to ensure that providers are convinced the innovations are worth the financial investment.

It's not about the lowest price point, that's just one part of the overall value equation, Cigna's Josephs said. It's about having more data and conceiving of partnership arrangements to help get there, according to Premier's DeVore. “Bring your evidence and data, and bring a willingness to collaborate and take risks,” she said.

Follow Sabriya Rice on Twitter: @MHsrice



Monday, October 6, 2014

Criminal?: Scottish Surgical Mesh Scandal

Revealed: Two doctors on mesh safetyreview team linked to makers of controversial devices

         Oct 05, 2014 13:53
         By Marion Scott  Daily Record (UK)  FiDA highlight

HEALTH Secretary Alex Neil under fire after victims claim the government probe into mesh implants is being rigged to give operations the all-clear.


Health Secretary Alex Neil
TWO doctors on the government team reviewing the safety of mesh implants have links to the makers of devices used in the controversial surgery.
The appointments have fuelled concern of campaigners that the review has been weighted to support the continued use of the procedures, which have left women around the world crippled and led to multi-million-pound compensation payments.
Ash Monga and Karen Guerrero have been paid by Ethicon, the makers of a mesh product called Gynecare.
Dr Monga described himself as a “consultant for Gynecare” in a 2009 medical research paper.
Dr Guerrero, a surgeon at Glasgow’s Victoria Infirmary, received “educational sponsorships” – including payments and travel costs – from Ethicon and another major mesh manufacturer called Bard.




Dr Karen Guerrero


He won plaudits in June after apparently suspending mesh procedures when Hear Our Voice campaigners, supported by the Sunday Mail, gave evidence to reveal how they have been left in crippling agony by mesh, used to treat prolapse and bladder problems.
At the time, Neil said: “I’m proud Scotland has taken this stance and I believe we are leading the way on what is a significant global problem.”
But we revealed the anger of campaigners last week after discovering government medical advisers wrote to hospitals within weeks of Neil’s announcement to say the suspension was voluntary and encouraged them to use mesh on patients as part of clinical trials.
Yesterday, politicians and campaigners raised new concerns about the appointments to the review body to establish if there are any conflicts of interest.
Scottish Labour’s shadow health secretary Neil Findlay said: “It is outrageous that, after taking over a year to reach a decision on mesh implants, the Health Secretary has appointed doctors to the review who might appear to have a vested interest.
“Those affected have been through far too much in the past few years and this latest development is simply inexcusable.”



Mesh product


Olive McIlroy, of Scottish Mesh Survivors, said: “We are dismayed that people appointed to carry out this vital review have such links to the manufacturers who profit from the use of these devices.
“Alex Neil promised victims would be at the very heart of the independent review but it feels very much like we are lone voices pitted against the country’s most powerful mesh supporters.”
Ethicon, a subsidiary of Johnson & Johnson, have twice had their TVT-O device declared as “defective” by a US court.
It has also emerged that Gibraltar-born Guerrero was among 23 signatories backing an objection to Neil’s suspension of mesh use in the NHS in June.
Dr Guerrero backed the call made by Aberdeen-based urology consultant Mohamed Abdel-Fattah asking for mesh trials to be exempted.
Abdel-Fattah, who has also received “travel sponsorship” from Ethicon, was supported by two other members of the review group, Professor Charis Glazener and consultant urologist Voula Granitsiotis.
Ethicon’s Lucinda Macari said: “Ethicon, in conjunction with the Association of British Healthcare Industries, are supporting efforts by the Scottish Independent Review to gather full and accurate information about pelvic mesh products.”
The Scottish Government said: “This must be an entirely independent review and will be completed as such.”
          
         Sep 14, 2014 14:11
         By Marion Scott  Daily Record (UK)
MARTHA Salazar's case in Dallas, Texas – the second major victory for mesh victims in America within days – prompts new calls for criminal inquiry in Scotland.


Campaigner Elaine Holmes in the Scottish Parliament.
AN American mesh patient has been awarded £60million compensation by a US court.
Martha Salazar won the huge payout after the court in Dallas, Texas, heard that the Obtryx implant made by Boston Scientific was defective.
They jury was also told that the manufacturers had failed to properly test the device on humans.
It was the second major victory for mesh victims in the States within days.
Earlier this month, Jo Huskey was awarded damages totalling £3million by a West Virginia court for pain and suffering caused by a TVT-O mesh 
implant made by Johnson & Johnson firm Ethicon.
Both these mesh devices were given to Scottish women on the NHS before the procedures were suspended pending safety reviews after an outcry by mesh victims.
The US payouts have led to politicians and victims calling for the Scottish Government to sue manufacturers and launch a criminal probe.
Labour’s shadow health secretary Neil Findlay said: “These cases are proof, if any further evidence is needed given the hundreds of women injured here, that the mesh scandal is shaping up to be a very big issue for Scotland’s NHS.
“It’s high time the Scottish Government challenged the manufacturers over the catastrophic health problems these devices have inflicted on so many women.
“If there’s evidence of clinic data and trial evidence being deliberately withheld, criminal action should be considered.”
Elaine Holmes, of Scottish Mesh Survivors, added: “A car manufacturer who did this would face a criminal investigation and lengthy jail sentences. It should be the same for mesh manufacturers.”
Lawyer Cameron Fyfe, who is acting for over 400 women involved in the biggest-ever medical legal action in Scotland, said: “Potential damages in 
Scotland would be a fraction of those in the US but we expect to have similar success.”

Gareth Easton

Scottish Health Secretary Alex Neil





Health Secretary Alex Neil suspended mesh operations in March pending an independent safety review.

It followed a Sunday Mail campaign which exposed the hidden agony of hundreds of women given mesh implants to treat incontinence and bladder problems.