I just want to understand how this is legal

MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.

I just want to understand how this is legal

PostPosted by hopeful19 » Wed Jan 18, 2012 9:44 pm

In reading the filings, in reporting my own damage, I want to understand how these responses are legal and acceptable. I want to understand how the FDA continues to do absolutely nothing to take any action to protect the public. It is incredibly hard to witness the ones causing the harm, given the authority to dismiss what is occurring. To me, what's going on here is the equivalent of placing a victim of rape in an examination room....... only to be evaluated, questioned and discredited by their rapist.
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
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Re: I just want to understand how this is legal

PostPosted by DCNGA » Wed Jan 18, 2012 10:18 pm

The fox guards the hen house with the entire FDA adverse event reporting process.

There are SO MANY reports on ophthalmic laser adverse events I cannot believe any of those lasers are allowed to come near a person's eyes.

I cannot remember the type of laser but there was one that must have had 300 reports in the last three months. How can that even be possible without that type laser being recalled?

No one cares about patient safety, least of all the FDA.
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Re: I just want to understand how this is legal

PostPosted by DCNGA » Wed Jan 18, 2012 10:25 pm

It was this laser and report after report. What is the FDA doing? Too scary for words. It is a surgical laser of some sort, not used in cosmetic surgery.

Catalog Number 0010-2400
Event Date 10/21/2011
Event Type Malfunction
Event Description
It was reported by a customer that on (b)(6) 2011 the fiber tip detached inside of the patient at 107,005 joules. Additional information reported by the customer was during set-up the aim test was performed and the beam was visible. During the procedure, it was observed that the beam shot straight away when the event occurred. It was observed that the laser activated fiber life and went into standby. Per the customer, the collapsing prostate tissue made it difficult to keep the fiber tip away from the tissue during lasing. The fiber tip came out when flushing with irrigation. There is no possibility that any pieces of the fiber cap still remain in the patient. The event did not cause any issues with the patient.


Search Alerts/Recalls



New Search | Submit an Adverse Event Report

Brand Name GREENLIGHT MOXY
Type of Device SURGICAL FIBER
Manufacturer (Section F) AMERICAN MEDICAL SYSTEMS, INC.
san jose CA 95134 2011

Manufacturer (Section D) AMERICAN MEDICAL SYSTEMS, INC.
san jose CA 95134 2011

Manufacturer Contact jon cornell, sr. manager
3070 orchard dr.
san jose , CA 95134-2011

Device Event Key 2409344
MDR Report Key 2331746
Event Key 2228622
Report Number 2937094-2011-02222
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/07/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date 08/12/2013
Device Catalogue Number 0010-2400
Device LOT Number 133A
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer 11/01/2011
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 10/24/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured 08/01/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial



And this one:

AMERICAN MEDICAL SYSTEMS, INC. GREENLIGHT ADDSTAT SURGICAL FIBER Back to Search Results

Catalog Number 0010-2090
Event Type Malfunction
Event Description
It was reported by a customer that the fiber forward fired and the fiber was damaged at the tip at 20,000 joules. Add'l info reported by the customer was during set-up an aim test was performed ant the beam was visible. During the procedure, the forward firing condition was noticed after 5 minutes and the fiber burned. There were no error codes displayed on the console when this event occurred. The user did not experience any injury from the use of the sys. The pt did not experience any difficulties as a result of the event. The physician decided to perform treatment with turp.


Search Alerts/Recalls



New Search | Submit an Adverse Event Report

Brand Name GREENLIGHT ADDSTAT
Type of Device SURGICAL FIBER
Manufacturer (Section F) AMERICAN MEDICAL SYSTEMS, INC.
san jose CA 95134 2011

Manufacturer (Section D) AMERICAN MEDICAL SYSTEMS, INC.
san jose CA 95134 2011

Manufacturer Contact jon cornell, sr. mgr.
3070 orchard dr.
san jose , CA 95134-2011

Device Event Key 2401636
MDR Report Key 2325285
Event Key 2222161
Report Number 2937094-2011-02181
Device Sequence Number 1
Product Code GEX
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/13/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 11/01/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date 05/21/2012
Device Catalogue Number 0010-2090
Device LOT Number 021H
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 10/13/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured 05/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial


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Re: I just want to understand how this is legal

PostPosted by hopeful19 » Wed Jan 18, 2012 10:45 pm

I guess my question from the beginning of this, remains the same. How does one make it right? How do you make the FDA accountable to be accountable? When do they say to the device manufacturer's, not good enough, back up your information with facts or start being accountable?
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
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Re: I just want to understand how this is legal

PostPosted by DCNGA » Wed Jan 18, 2012 10:49 pm

I'm not sure what the catalyst would be since nothing ever seems to be bad enough to force them to do any of what you're asking/suggesting.

How do we hold the FDA accountable? I have yet to figure that out since they are a federal agency and dealing with that is almost insurmountable for the common lay person.
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Re: I just want to understand how this is legal

PostPosted by Erica » Wed Jan 18, 2012 10:53 pm

As a country, we can certainly do much, much better than this..... But I think about countries that seem to care more about the welfare of their people (Sweden) and they have problems too. All so frustrating. It really is astonishing that LASIK continues, you would think the FDA would at least care about people being blinded.
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Re: I just want to understand how this is legal

PostPosted by bluebuzz81 » Thu Jan 19, 2012 1:42 pm

I personally think, they know that it's bad, but they are not doing anything about it. Maybe someone is shoving money or something. I dunno~ I mean after reading and reading.... dermatology papers and books, I now know it's not something that's good for you. And personally I have not heard of doctors doing lasers or IPL. Just a thought~
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Re: I just want to understand how this is legal

PostPosted by Erica » Thu Jan 19, 2012 2:40 pm

Corporations run this county and laser companies wield alot of power.. Wasn't there a post about FDA employees having luncheons with laser co. execs? Think of the drug companies, HUGE! They are definitely in bed together and the problems will continue until this ends.
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Re: I just want to understand how this is legal

PostPosted by bluebuzz81 » Thu Jan 19, 2012 3:18 pm

I am sure there are major lobbying going without a doubt.
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Re: I just want to understand how this is legal

PostPosted by DCNGA » Thu Jan 19, 2012 3:35 pm

bluebuzz81 wrote:I am sure there are major lobbying going without a doubt.



By DAN EGGEN, The Washington Post
September 6, 2011Like many federal contractors, General Electric has a lot riding on the work of a new congressional “supercommittee,” which will help decide whether to impose massive cuts in defense and health-care spending.

But the Connecticut-based conglomerate also has a potential advantage: A number of its lobbyists used to work for members of the committee, and will be able to lobby their former employers to limit the impact of any reductions in the weeks ahead.

GE is hardly alone: Nearly 100 registered lobbyists used to work for members of the supercommittee, now representing defense companies, health-care conglomerates, Wall Street banks and others with a vested interest in the panel’s outcome, according to a Washington Post analysis of disclosure data. Three Democrats and three Republicans on the panel also employ former industry lobbyists on their staffs.

The preponderance of lobbyists adds to the political controversy surrounding the supercommittee, which will begin its work in earnest this week as Congress returns to Washington. The panel has already come under fire from watchdog groups for planning its activities in secret and allowing members to continue fundraising while they negotiate a budget deal.

“When the committee sits down to do its work, it’s not like they’re in an idealized, platonic debating committee,” said Bill Allison, editorial director of the Sunlight Foundation, which is tracking ties between lobbyists and the panel. “They’re going to have in mind the interests of those they are most familiar with, including their big donors and former advisers.”

The 12-member committee is tasked with identifying $1.5 trillion in long-term spending reductions by Thanksgiving, with a final plan to be approved by Congress. If no deal is reached, however, $1.2 trillion in across-the-board cuts will be triggered beginning in 2013, with the amount evenly divided between defense and non-defense programs.

The sheer scale of the trigger plan has set off something close to panic on K Street, as many of the nation’s largest industries face reductions in potential revenue from federal programs.

Defense contractors, for instance, are eager to push the panel toward a new agreement that reduces the scale of cuts to the Pentagon. The health-care sector, meanwhile, has a multitude of worries, from potential reductions in hospital payments to proposals to limit prescription drug prices under Medicare.

“Everybody in the Western world will be trying to influence the supercommittee at the same time,” said Loren B. Thompson, a defense industry consultant at the Lexington Institute. “If it was constructed to scare the daylights out of the political system, it’s certainly done the job.”

The stakes are particularly enormous for a diversified company such as GE, which has been awarded nearly $32 billion in federal contracts over the past decade, much of that to its lucrative defense and health-care subsidiaries, according to government tallies. GE chief executive Jeffrey Immelt also heads President Obama’s Council on Jobs and Competitiveness.

At least eight current GE lobbyists used to work for members of the supercommittee, including the firm’s chief lobbyist on Capitol Hill, according to the Post analysis, which drew on data from the Center for Responsive Politics, lobbying disclosure forms and other public records.

GE officials declined repeated requests for comment over the past two weeks. A spokesman said late Monday that the company is “not lobbying the supercommittee on any of its work.”

One GE lobbyist is Arshi Siddiqui, a former counsel to Rep. Xavier Becerra (D-Calif.), a member of the committee. Siddiqui, who also represents other business clients at Akin Gump, said in an interview that her time in Becerra’s office will have no bearing on the outcome of the debt-reduction talks.

“I’m a firm believer that everything will be on the table and everything will be litigated openly in this process,” Siddiqui said. “The stakes are too high, and members will ultimately make those determinations on the merits.”

Becerra said in a statement that neither his former employees nor their clients will get special treatment.

“I will treat my work on this joint select committee no differently than I have my work as a member of Congress for the last 19 years,” Becerra said. “My decisions and votes speak for themselves. I firmly believe that each member privileged to serve on this joint select committee must be prepared to check their preconditions, special-interest pledges and sacred cows at the door.”

Overall, two-thirds of the lobbyists with committee ties are Democrats, including about two dozen former aides to Sen. Max Baucus (D-Mont.), the powerful chairman of the Senate Finance Committee, records show. Baucus alumni include former staff chiefs David Castagnetti, who represents health insurers, oil producers and other corporate clients; Jeff Forbes, who lobbies for medical-device makers and other health-care firms; and Peter Prowitt, who leads GE’s Washington lobbying team.

About two dozen lobbyists contacted for this article either declined to comment or did not respond to interview requests. Baucus’s office said in a statement: “Money has never influenced the decisions Max makes, and he’ll continue to do what’s right for working Montana families, regardless of outside interests.”

Sen. Patty Murray (D-Wash.), who serves as co-chairman of the supercommittee, has employed more than a dozen currently registered lobbyists, records show. Murray’s counterpart, Rep. Jeb Hensarling (R-Tex.), employs a former lobbyist as a senior adviser but has only two former employees now on K Street, the data show.

Murray, a four-term senator, is widely known for her spirited defense of industries important to the Pacific Northwest, including computer software firms and defense contractors. At least two former Murray staffers now represent aircraft giant Boeing, including former legislative affairs aide Shay Michael Hancock, who also represents GE and several defense contractors.

Hancock did not respond to a request for comment. Murray’s office said her former employees’ lobbying efforts will have no impact on her decisions.

“As she has throughout her career, Sen. Murray will be listening to the needs of everyday families, not lobbyists, as she weighs the tough decisions this committee is faced with,” communications director Matt McAlvanah said.

Sen. John F. Kerry (D-Mass.) has more than a dozen former staffers who now work as Washington lobbyists. Spokeswoman Jodi Seth said, “It’s rare that Sen. Kerry meets with lobbyists, and his record across the board makes it clear his decisions are based on the interests of Massachusetts and his own clearly established worldview after 26 years in the Senate.”

Another supercommittee member, Sen. Jon Kyl (R-Ariz.), has at least 10 former aides who now work as lobbyists for some of the nation’s largest companies. Aides to Kyl, who is not running for reelection in 2012, did not respond to requests for comment.

One of Washington’s most influential lobbying groups, the Pharmaceutical Research and Manufacturers of America, employs lobbyists who previously worked for Murray, Baucus, Kerry and Rep. Dave Camp (R-Mich.). One top aide to Rep. Fred Upton (R-Mich.) also used to represent PhRMA as a health-care industry lobbyist.

The drugmaker group says it will lobby against a Democratic proposal to require rebates for prescription drugs provided to low-income seniors through Medicare, a move estimated to save $112 billion over 10 years while also reducing costs to patients.

But PhRMA says the idea amounts to price-fixing and would hurt the Medicare prescription drug benefit, a program approved during the George W. Bush administration.

“It will certainly be a priority to educate policymakers about that issue as we get into the fall,” PhRMA spokesman Matt Bennett said. “We think policymakers need to understand how valuable the program is.”

Like many federal contractors, General Electric has a lot riding on the work of a new congressional “supercommittee,” which will help decide whether to impose massive cuts in defense and health-care spending.

But the Connecticut-based conglomerate also has a potential advantage: A number of its lobbyists used to work for members of the committee, and will be able to lobby their former employers to limit the impact of any reductions in the weeks ahead.

GE is hardly alone: Nearly 100 registered lobbyists used to work for members of the supercommittee, now representing defense companies, health-care conglomerates, Wall Street banks and others with a vested interest in the panel’s outcome, according to a Washington Post analysis of disclosure data. Three Democrats and three Republicans on the panel also employ former industry lobbyists on their staffs.

The preponderance of lobbyists adds to the political controversy surrounding the supercommittee, which will begin its work in earnest this week as Congress returns to Washington. The panel has already come under fire from watchdog groups for planning its activities in secret and allowing members to continue fundraising while they negotiate a budget deal.

“When the committee sits down to do its work, it’s not like they’re in an idealized, platonic debating committee,” said Bill Allison, editorial director of the Sunlight Foundation, which is tracking ties between lobbyists and the panel. “They’re going to have in mind the interests of those they are most familiar with, including their big donors and former advisers.”

The 12-member committee is tasked with identifying $1.5 trillion in long-term spending reductions by Thanksgiving, with a final plan to be approved by Congress. If no deal is reached, however, $1.2 trillion in across-the-board cuts will be triggered beginning in 2013, with the amount evenly divided between defense and non-defense programs.

The sheer scale of the trigger plan has set off something close to panic on K Street, as many of the nation’s largest industries face reductions in potential revenue from federal programs.

Defense contractors, for instance, are eager to push the panel toward a new agreement that reduces the scale of cuts to the Pentagon. The health-care sector, meanwhile, has a multitude of worries, from potential reductions in hospital payments to proposals to limit prescription drug prices under Medicare.

“Everybody in the Western world will be trying to influence the supercommittee at the same time,” said Loren B. Thompson, a defense industry consultant at the Lexington Institute. “If it was constructed to scare the daylights out of the political system, it’s certainly done the job.”

The stakes are particularly enormous for a diversified company such as GE, which has been awarded nearly $32 billion in federal contracts over the past decade, much of that to its lucrative defense and health-care subsidiaries, according to government tallies. GE chief executive Jeffrey Immelt also heads President Obama’s Council on Jobs and Competitiveness.

At least eight current GE lobbyists used to work for members of the supercommittee, including the firm’s chief lobbyist on Capitol Hill, according to the Post analysis, which drew on data from the Center for Responsive Politics, lobbying disclosure forms and other public records.

GE officials declined repeated requests for comment over the past two weeks. A spokesman said late Monday that the company is “not lobbying the supercommittee on any of its work.”

One GE lobbyist is Arshi Siddiqui, a former counsel to Rep. Xavier Becerra (D-Calif.), a member of the committee. Siddiqui, who also represents other business clients at Akin Gump, said in an interview that her time in Becerra’s office will have no bearing on the outcome of the debt-reduction talks.

“I’m a firm believer that everything will be on the table and everything will be litigated openly in this process,” Siddiqui said. “The stakes are too high, and members will ultimately make those determinations on the merits.”

Becerra said in a statement that neither his former employees nor their clients will get special treatment.

“I will treat my work on this joint select committee no differently than I have my work as a member of Congress for the last 19 years,” Becerra said. “My decisions and votes speak for themselves. I firmly believe that each member privileged to serve on this joint select committee must be prepared to check their preconditions, special-interest pledges and sacred cows at the door.”

Overall, two-thirds of the lobbyists with committee ties are Democrats, including about two dozen former aides to Sen. Max Baucus (D-Mont.), the powerful chairman of the Senate Finance Committee, records show. Baucus alumni include former staff chiefs David Castagnetti, who represents health insurers, oil producers and other corporate clients; Jeff Forbes, who lobbies for medical-device makers and other health-care firms; and Peter Prowitt, who leads GE’s Washington lobbying team.

About two dozen lobbyists contacted for this article either declined to comment or did not respond to interview requests. Baucus’s office said in a statement: “Money has never influenced the decisions Max makes, and he’ll continue to do what’s right for working Montana families, regardless of outside interests.”

Sen. Patty Murray (D-Wash.), who serves as co-chairman of the supercommittee, has employed more than a dozen currently registered lobbyists, records show. Murray’s counterpart, Rep. Jeb Hensarling (R-Tex.), employs a former lobbyist as a senior adviser but has only two former employees now on K Street, the data show.

Murray, a four-term senator, is widely known for her spirited defense of industries important to the Pacific Northwest, including computer software firms and defense contractors. At least two former Murray staffers now represent aircraft giant Boeing, including former legislative affairs aide Shay Michael Hancock, who also represents GE and several defense contractors.

Hancock did not respond to a request for comment. Murray’s office said her former employees’ lobbying efforts will have no impact on her decisions.

“As she has throughout her career, Sen. Murray will be listening to the needs of everyday families, not lobbyists, as she weighs the tough decisions this committee is faced with,” communications director Matt McAlvanah said.

Sen. John F. Kerry (D-Mass.) has more than a dozen former staffers who now work as Washington lobbyists. Spokeswoman Jodi Seth said, “It’s rare that Sen. Kerry meets with lobbyists, and his record across the board makes it clear his decisions are based on the interests of Massachusetts and his own clearly established worldview after 26 years in the Senate.”

Another supercommittee member, Sen. Jon Kyl (R-Ariz.), has at least 10 former aides who now work as lobbyists for some of the nation’s largest companies. Aides to Kyl, who is not running for reelection in 2012, did not respond to requests for comment.

One of Washington’s most influential lobbying groups, the Pharmaceutical Research and Manufacturers of America, employs lobbyists who previously worked for Murray, Baucus, Kerry and Rep. Dave Camp (R-Mich.). One top aide to Rep. Fred Upton (R-Mich.) also used to represent PhRMA as a health-care industry lobbyist.

The drugmaker group says it will lobby against a Democratic proposal to require rebates for prescription drugs provided to low-income seniors through Medicare, a move estimated to save $112 billion over 10 years while also reducing costs to patients.

But PhRMA says the idea amounts to price-fixing and would hurt the Medicare prescription drug benefit, a program approved during the George W. Bush administration.

“It will certainly be a priority to educate policymakers about that issue as we get into the fall,” PhRMA spokesman Matt Bennett said. “We think policymakers need to understand how valuable the program is.”

"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: I just want to understand how this is legal

PostPosted by DCNGA » Thu Jan 19, 2012 3:37 pm

Advanced Medical Technology Association or AdvaMed (here) calls itself the world’s largest medical technology association. In other words, it is the lobbying arm of the medical device industry ....

Revolving Door

Lobbyists often come from inside the beltway jobs, working for Congress in a variety of capacities. In this way they have already established contacts which presumably are helpful in advancing a message. Associated Press lists the following new employees of AdvaMed:

Elizabeth Sharp, a former employee of Rep. Tammy Baldwin, D-Wis.;

Elizabeth Kegler, a former staffer for Sen. Charles Grassley, R-Iowa;

Juan Carlos Scott, who held a variety of positions that included working for former Ohio Rep. Deborah Pryce, a Republican;

Duane Wright, who worked in the offices of Sen. Tom Carper, D-Del., and former Rep. Jim Davis, D-Fla.

"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: I just want to understand how this is legal

PostPosted by DCNGA » Thu Jan 19, 2012 3:42 pm

Wednesday, January 5, 2011
John Boehner adds medical device industry’s chief lobbyist as his policy director #p2 @gop @gopleader #tcot
from http://www.politico.com/news/stories/1210/46211.html

House Speaker-elect John Boehner announced Thursday that he hired the medical device industry's chief lobbyist as his policy director,
"It is a good thing to learn caution from the misfortunes of others."

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Re: I just want to understand how this is legal

PostPosted by DCNGA » Thu Jan 19, 2012 3:54 pm

December 19, 2011 by MassDevice staffMedical device companies and industry groups spent nearly $32 million lobbying Congress during the third quarter.

Medical device industry lobbyists ramped up their spending during the 3rd quarter, dropping nearly $32 million on Washington in the 3 months ended Sept. 30.

The reports mark a continued incline for the industry's spending on Capitol Hill, which hit nearly $28 million last quarter and $20 million in Q1.

"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: I just want to understand how this is legal

PostPosted by hopeful19 » Thu Jan 19, 2012 6:17 pm

:shock:
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
-Einstein
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Re: I just want to understand how this is legal

PostPosted by Erica » Thu Jan 19, 2012 10:30 pm

DCNGA wrote:
Wednesday, January 5, 2011
John Boehner adds medical device industry’s chief lobbyist as his policy director #p2 @gop @gopleader #tcot
from http://www.politico.com/news/stories/1210/46211.html

House Speaker-elect John Boehner announced Thursday that he hired the medical device industry's chief lobbyist as his policy director,


Disturbing and discouraging. I'm not suprised. Our system is so broken.
“It always seems impossible until it's done.” Nelson Mandela
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