AMS (American Medical Systems,now Endo and J&J (Johnson & Johnson/JNJ) HARM Women FOR PROFIT in AU

Australian Medical Association president confirms AMA WA(Western Australia)’s role in pelvic mesh scandal

• Joanne McCarthy  AUGUST 22 2017 - 12:11PM

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The Australian Medical Association acted as exclusive distributor of an Australian-invented pelvic mesh device for women that helped spark a global pelvic mesh scandal after it was sold and registered for use in America in 2001.

The AMA's marketing of the Intravaginal Sling (IVS) Tunneller device as an "Australian medical design breakthrough" to treat incontinence and prolapse, despite women's reports of complications in Western Australian public hospital trials from as early as 1989, was "a long way from our proudest hour", said current AMA president Dr Michael Gannon.

Australian Medical Association national president Dr Michael Gannon confirmed the AMA promoted and distributed a pelvic mesh device for women that helped spark a global pelvic mesh scandal. 

"It is unfortunately the case that many women have been injured by these kinds of operations. To call this a tragedy is not overstating it at all," he said, after confirming a wholly-owned subsidiary of the AMA's Western Australian branch promoted and exclusively distributed the IVS device.

It was a controversial decision that "I'm sure they now regret", and which some Perth gynaecologists continued to be unhappy about more than 15 years later, he said.

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"I can only answer that in good faith the AMA WA thought it was a good product. History will not judge that decision kindly. It already has not judged that decision kindly," Dr Gannon said.

His comments come only months after the Royal Australian and New Zealand College of Obstetricians and Gynaecologists conceded there was "very little robust information" of the long term safety of some prolapse mesh devices, despite estimates more than 30,000 Australian women received them.

The IVS Tunneller's sale to Tyco Health and registration in America in April, 2001 was used by pharmaceutical giants, including Johnson & Johnson, to register their own prolapse devices by arguing they were "substantially the same" as IVS and subsequent devices, without producing independent evidence of safety. They were then cleared for use in Australia.

More than 700 Australian women alleging serious and permanent injuries after pelvic mesh surgery for incontinence and prolapse are suing Johnson & Johnson in a Federal Court case in Sydney.

An Australian Medical Association document describing the IVS Tunneller device as an "Australian medical design breakthrough" to treat incontinence and prolapse in women.

Another 300 Australian women are registered for a second class action against American Medical Systems (AMS), which developed pelvic mesh devices including Perigee and Apogee. Apogee was cleared for use in America in 2004, after AMS argued it was "substantially the same" as the Australian-invented IVS Tunneller.

Dr Gannon, a Western Australian obstetrician and gynaecologist, said he was aware of "hundreds of operations" by Perth specialists trying to "remedy the damage" caused by mesh devices including the IVS.

Australian Pelvic Mesh Support Group members fought for a Senate inquiry into how pelvic mesh devices were cleared for use in Australia. 

"I have been personally involved in the care of women who have suffered greatly from bladder dysfunction, bowel dysfunction and sexual dysfunction because of some of these devices," he said.

It was a "regulatory failure that so many individual women were damaged".

"The TGA (Therapeutic Goods Administration) takes great care when it looks at new medicines entering the market, but I don't think they are resourced to take the same care with devices. We would like to see them use the same blowtorch on devices as applies to medicines," he said.

Perth woman Jeanette McKinnon, who said she "wanted to vomit" several weeks ago when a specialist confirmed she was implanted with at least two mesh devices at the Bentley public hospital in 2004 and 2005, allegedly without her knowledge or consent, was outraged when told of the AMA's involvement.

"I'm absolutely horrified. I'm so angry I'm shaking. That this has been allowed to go on, and the AMA's been involved. How dare they? We're human beings," Mrs McKinnon said.

The IVS Tunneller device was developed during experiments on 13 large dogs in 1987 by inventor Dr Peter Petros and other Royal Perth Hospital doctors.

A WA East Metropolitan Health Service spokesperson confirmed Royal Perth Hospital approved a research study in 1989 into the IVS device and procedure. It was granted standard clinical practice status by the hospital's ethics committee in 1993.

A Medical Journal of Australia report in July, 1994 acknowledged many doctors were critical of the procedure.

In February 2001, only two months before the IVS Tunneller was cleared for use in America as an incontinence and prolapse device, the Royal Australasian College of Surgeons found there was "no peer-reviewed, good quality evidence available to determine the safety and efficacy of the IVS procedure to treat women's incontinence". There was no assessment of its use to treat prolapse.

In a paper in 2003 called "Intravaginal Sling Distress", three Australian specialists, including Newcastle gynaecologist Alan Hewson and Brisbane gynaecologist Chris Maher, reported "disconcerting complications" in women after IVS surgery, including infections, pain syndromes and "symptoms debilitating to the patient's and partner's quality of life".

"Until further data on the safety and efficacy of the IVS procedures is available they cannot be recommended," they concluded.

A 2010 Melbourne Mercy Hospital for Women review of 10 years of pelvic mesh surgery found the IVS device had significantly higher rates of pain, mesh erosion and infection complication rates than eight other devices reviewed.

Dr Petros did not respond to Newcastle Herald questions.

In a paper in 2012 Dr Petros said his "early experimental studies" had been "wrongly" used as "an intellectual cornerstone to justify the use of mesh in prolapse surgery".

In the paper he distanced himself from the global mesh scandal, saying complications were related to "large sheet" mesh adopted by some companies, and not the small tapes advocated by him which preserved "vaginal elasticity".

In a submission to a Senate inquiry into pelvic mesh devices, which will hold its second public hearing in Perth on Friday, Dr Petros referenced his 1990 paper produced after trialling the Intravaginal Sling procedure on "13 female mongrel dogs", in association with Royal Perth Hospital and the University of Western Australia.

-  Newcastle Herald

http://www.watoday.com.au/wa-news/australian-medical-association-president-confirms-ama-was-role-in-pelvic-mesh-scandal-20170822-gy1hzj.html

Outrageous!

Medical Device CEO Douglas W. Kohrs retires at age 54. 

His salary $2.6M while company (Tornier) did not profit for 3 years.  

Tornier Promotional YouTube video

Tornier Appoints David H. Mowry as Interim President and Chief Executive Officer

By Business Wirevia The Motley Fool

Posted 4:34PM 11/12/12

Posted under: Investing

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Tornier Appoints David H. Mowry as Interim President and Chief Executive Officer

Medical Device Industry Veteran Kevin C. O'Boyle Named Interim Vice Chairman

AMSTERDAM--(BUSINESS WIRE)-- Tornier N.V. (NAS: TRNX) , a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, today announced the appointment of David H. Mowry as Interim President and Chief Executive Officer, effective immediately. Mr. Mowry succeeds Douglas W. Kohrs, who has retired as President, Chief Executive Officer and Executive Director. Also effective immediately, Non-Executive Director, Kevin C. O'Boyle was named Interim Vice Chairman to serve as a liaison between Mr. Mowry and the Board.

Mr. Mowry, 50, will work with Mr. O'Boyle and Mr. Kohrs to ensure a smooth and orderly transition as the Board of Directors conducts a search for a permanent CEO.

Sean D. Carney, Chairman of Tornier, commented, "On behalf of the company and the Board of Directors, I would like to express our appreciation to Doug, for his leadership and contribution in building the Tornier business over the past six years. Doug was instrumental in bringing Tornier public, leading the recent acquisition of the OrthoHelix business and expanding our international footprint, core capabilities and the innovation pipeline."

Douglas W. Kohrs commented, "I have greatly enjoyed my tenure with Tornier, and am proud to have had the opportunity to work with a fantastic team in growing the company to be one of the most prominent providers of orthopaedic solutions. I have great confidence in the skills and talent of Dave and rest of the management team and their ability to continue to execute on the strategy we have laid out together."

David H. Mowry, Interim President and Chief Executive Officer of Tornier, commented, "I appreciate the opportunity to accept this expanded role with the company. I look forward to working with the Board and the talented management team in continuing to build the strong brand and reputation we have established at Tornier over the past 70 years."

"As we look ahead to the next phase of Tornier's growth, we are pleased Dave has agreed to take on additional responsibility to lead the company with the rest of the management team," continued Mr. Carney. "Dave's experience in the industry and specifically with Tornier provides confidence that he will continue to drive forward the strategic growth plans we have been executing."

Mr. Mowry joined Tornier N.V. in July 2011 as Chief Operating Officer. He brings to Tornier 23 years of medical device industry experience in various engineering and management assignments. Prior to Tornier, Mr. Mowry served as Senior Vice President and President of the Neurovascular Division of Covidien plc, and in the same position with ev3 Inc., prior to its acquisition by Covidien. Mr. Mowry is a graduate of the United States Military Academy in West Point, New York with a degree in Engineering.

As Interim Vice Chairman, Mr. O'Boyle will serve as a liaison between the Interim President and Chief Executive Officer and the Board. Mr. O'Boyle has served as a director of Tornier since June 2010. Since December 2010, Mr. O'Boyle has served as Senior Vice President and Chief Financial Officer of Advanced BioHealing Inc., a medical device company which was acquired by Shire PLC in May 2011, and since June 2011 has served as Senior Vice President of Business Operations. From January 2003 until December 2009, Mr. O'Boyle served as the Chief Financial Officer of NuVasive, Inc. He currently serves on the Board of GenMark Diagnostics, Inc., a molecular diagnostics company. Mr. O'Boyle is a Certified Public Accountant and received a Bachelor of Science degree in Accounting from the Rochester Institute of Technology and completed the Executive Management Program at the University of California Los Angeles, John E. Anderson Graduate Business School.

Tornier is reiterating its previously issued financial guidance for the remainder of 2012, which is contained in Tornier's earnings release issued on November 5, 2012.

Forward-Looking Statements

Statements contained in this release that relate to future, not past, events are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on current expectations of future events and often can be identified by words such as "expect," "should," "project," "anticipate," "intend," "will," "may," "believe," "could," "would," "continue," "outlook," "guidance," "future," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Tornier's actual results to be materially different than those expressed in or implied by Tornier's forward-looking statements. For Tornier, such uncertainties and risks include, among others, Tornier's future operating results and financial performance, fluctuations in foreign currency exchange rates, the effect of global economic conditions, the European sovereign debt crisis, and austerity measures, risks associated with Tornier's international operations and expansion, risks associated with Tornier's recent acquisition of OrthoHelix and the new credit facility agreement, the timing of regulatory approvals and introduction of new products, physician acceptance, endorsement, and use of new products; the effect of regulatory actions, changes in and adoption of reimbursement rates, potential product recalls, competitor activities, the effect of changes in Tornier's distribution channels and the costs and effects of litigation, risks associated with Tornier's recent management changes; and changes in tax and other legislation. More detailed information on these and other factors that could affect Tornier's actual results are described in Tornier's filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. Tornier undertakes no obligation to update its forward-looking statements.

About Tornier

Tornier is a global medical device company focused on serving extremities specialists who treat orthopaedic conditions of the shoulder, elbow, wrist, hand, ankle and foot. The Company's broad offering of over 100 product lines includes joint replacement, trauma, sports medicine, and ortho-biologic products through Tornier and OrthoHelix brands to treat the extremities, as well as joint replacement products for the hip and knee in certain international markets. Since its founding approximately 70 years ago, Tornier's "Specialists Serving Specialists" philosophy has fostered a tradition of innovation, intense focus on surgeon education, and commitment to advancement of orthopaedic technology stemming from its close collaboration with orthopaedic surgeons and thought leaders throughout the world. For more information regarding Tornier, visit www.tornier.com, or OrthoHelix, visit www.orthohelix.com.

Tornier N.V.
Shawn McCormick
Chief Financial Officer
(952) 426-7646
shawn.mccormick@tornier.com

http://www.fool.com/investing/general/2012/11/13/why-tornier-shares-tumbled.aspx

Why Tornier Shares Tumbled

By Jeremy Bowman


November 13, 2012 |

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of medical-device maker Tornier (Nasdaq: TRNX  ) were getting tripped up today, falling as much as 15% after a downgrade from Northland Securities.

So what: The downgrade, from "market perform" to "underperform," came on the heels of yesterday's surprise announcement that 54-year-old CEO Doug Kohrs was leaving the company.

"The sudden nature of the announcement combined with the recent deceleration in sales growth could raise questions 2013 outlook for the company," Northland said.

Tornier has missed EPS estimates in its last two quarters with a $0.29 loss in its most recent quarter.

Now what: Countering Northland's opinion was investment house Piper Jaffray, which reaffirmed its overweight rating on Tornier today. Speculating about Kohrs' departure is unlikely to lead to any sure answers, but investors may want to be reminded that Tornier has yet to turn a profit in its three-year history, and with growth slowing this could be a problem. Analysts are eyeing small losses for the next two quarters as well. I'd wait for new CEO David Mowry to prove himself by getting the company into positive territory before getting on board.

http://www.bizjournals.com/twincities/news/2012/05/18/pay-tornier-kohrs.html

Tornier CEO Kohrs gets 59 percent payraise

Minneapolis / St. Paul Business Journal by Ed Stych, Web Producer

Date: Friday, May 18, 2012, 2:59pm CDT

Ed Stych

Web Producer- Minneapolis / St. Paul Business Journal

Now making more than $2.6 million

Tracking the pay of Minnesota’s business leaders

Douglas Kohrs

CEO

Tornier Inc. (Nasdaq: TRNX)

•                         Headquarters: Dutch company with U.S. headquarters in Edina

•                         Business: Makes orthopedics devices

Total pay

         2011: $2.61 million, up 59 percent

         2010: $1.64 million

         2009: $1.25 million

Base salary

         2011: $503,000

         2010: $490,000

Bonus

         2011: None

         2010: None

Incentive pay

         2011: $209,000

         2010: $237,000

Stock awards

         2011: $830,000

         2010: None

Option awards

         2011: $1.07 million

         2010: $913,000

Other compensation

         2011: None

         2010: None

Total compensation for other highly-compensated executives:

            Carmen Diersen, chief financial officer: $1.02 million, down 52 percent

         David Mowry, chief operating officer: $1.20 million (first year with company)

            Stéphan Epinette, vice president of International Commercial Operations: $932,000, up 12 percent

            Kevin Klemz, chief legal officer: $739,000, down 27 percent

Notes

Data comes from documents filed with the U.S. Securities and Exchange Commission.

Ed Stych reports on Twin Cities breaking business news for mspbj.com, manages online features and writes the Workshop and Fast 50 Diary features for the print edition

http://ryortho.com/companyNews.php?news=2321_Tornier-CEO-Retires-Abruptly

Tornier CEO Retires Abruptly

Orthopedics This Week / Walter Eisner • Wed, Nov 14th, 2012

It was a surprise retirement.

Tornier N.V. announced on November 12 that the company's President and CEO, Doug Kohrs was retiring. David Mowry, the company's chief operating officer was immediately named interim president and CEO.

Kohrs was clearly the captain of this ship. Sean Carney, the company's board chair noted Kohrs', "leadership and contribution in building the Tornier business over the past six years. Doug was instrumental in bringing Tornier public, leading the recent acquisition of the OrthoHelix business and expanding our international footprint, core capabilities and the innovation pipeline."

Why?

In the world of publicly traded companies, retirements are usually well-orchestrated and telegraphed well ahead of time to keep investors calm. So why didn't this happen with Kohrs and Tornier?

BMO Capital Markets analyst Joanne Wuensch wrote that she was not a fan of this announcement, "particularly on the heels of the departure of CFO Carmen L. Diersen in July 2012. We could speculate that the departure is simply a personal decision (and take it at face value), or take the view that after several missteps since its February 2011 IPO, it was time for new senior leadership. What we do not read into this announcement is anything nefarious (the consulting agreement appears to imply that they are departing on reasonably good terms)."

Bank of America analyst Bob Hopkins said that his conversations with the company suggested that Kohrs did want to retire over the course of the next 12-18 months. However he believes Kohrs departure was probably hastened "due to [Tornier's] recent well-documented issues and the lack of value creation since the IPO. Importantly, we do not believe any new issues have arisen since last week's Q3 call, and Mr. Kohrs has signed a six month consulting agreement with [Tornier] to help with the transition, and remains one of the largest shareholders."

Kohrs, according to a company SEC filing, will receive $2,500 per month for up to eight hours of consulting services per month and will be compensated at a rate of $300 per hour for any additional hours.

Mowry and O’Boyle Assume Leadership

Mowry joined Tornier in July 2011 as chief operating officer. He has 23 years of medical device industry experience in various engineering and management assignments. Prior to Tornier, Mowry served as senior vice president and president of the Neurovascular Division of Covidien plc, and in the same position with ev3 Inc., prior to its acquisition by Covidien. He is a graduate of the United States Military Academy in West Point, New York with a degree in engineering.

Kevin O'Boyle, the former chief financial officer of NuVasive, Inc. and one of Tornier's non-executive board members was named interim vice chairman to serve as a liaison between Mowry and the board.

Wuensch said that while the company clearly has work to do, her thesis is that, with the distribution changes well under way, and the OrthoHelix acquisition filling an important hole in the company's extremity bag, the current strategy should accelerate the top-line growth rate over the coming quarters.

While this "unnecessarily awkward transition" creates as much risk as opportunity for the company, Hopkins said he continues to see real long-term value in the franchise. He notes that Kohrs, "leaves behind a strong bench; the Tornier brand remains strong; their markets are healthy; Warburg [owner of 47% of Tornier] has a best in class track record with management changes in their portfolio companies and Tornier remains comfortable with 2012 guidance and with 2013 guidance that calls for a return to double-digit top-line growth by midyear."

Kohrs' Record

Kohrs was CEO of American Medical Systems Holdings, Inc.from 1995 to 2005 before turning that firm into a publicly-traded company. Prior to that he co-founded Spine-Tech, Inc. which was later acquired by Sulzer Medica A.G.

According to a July 2012 TwinCities Business article, Kohrs left American Medical in 2006 to become entrepreneur-in-residence at Split Rock Partners. That's when he convinced a group of investors to buy the French family-owned Tornier. Tornier's sales have grown from $100 million in revenues in 2006 to $261 million last year. When he took over, Tornier sold 23 products in 15 European countries; today it sells 100 products in 45 countries worldwide, including Japan, China, Australia, and Argentina. Headcount worldwide has jumped from 350 to 800.

Whether Kohrs stays retired or continues his serial entrepreneurial track record is unknown.