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Former FDA Drug Reviewer Speaks Out About Pressures to Approve Drugs

Jane Akre
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7/30/2012

Martha Rosenberg for Truthout (here) interviewed Ronald Kavanagh B.S. Pharm., Pharm. D. Ph.D who reviewed drugs for the Center for Drug Evaluation and...

Possible Expansion of Vaginal Mesh Litigation to Include Coloplast

Jane Akre
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7/26/2012

Judge Joseph R. Goodwin July 26, 2012 ~ A panel of federal judges will meet on Thursday, July 26, to decide whether or not to expand vaginal mesh lit…

One Bard Vaginal Mesh Trial Down - Thousands More to Go

Jane Akre
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7/25/2012

Bard Trial Set to Begin February 2013 U.S. District Court, Charleston, West Virginia Friday’s $5.5 million verdict against C.R. Bard over its transva...

C.R. Bard Loses $5.5 Million in Landmark Vaginal Mesh Lawsuit

Jane Akre
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7/24/2012

Christine Scott, KGET-TV, Bakersfield, CA. July 24, 2012 ~ BREAKING NEWS! “Thank You God. We can finally get the word out to women.” Those are the w…

When Marlex Mesh Erosion Appears as Irritable Bowel Syndrome

Jane Akre
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7/20/2012

Marlex Mesh Erosion, J of the American Board of Family Medicine July 20, 2012 ~ In this published report in the Journal of the American Board of Fami...

Could J & J Implosion Lead to Better Oversight?

Jane Akre
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7/20/2012

July 19, 2012 ~ Is more corporate oversight needed by Johnson & Johnson? After years of defective medications, contaminated children’s cold products, …

Patient Advocate Joleen Chambers Needs Your Vote!

Jane Akre
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7/18/2012

Joleen Chambers Texas-based patient advocate, Joleen Chambers heads FIDA, FAILED Implant Device Alliance, their website is here. Chambers is inte...

Campaign Against FDA Whistleblowers Inquiry Heats Up

Jane Akre
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7/17/2012

July 16, 2012 ~Most Americans believe the U.S. Food and Drug Administration (FDA) does a fairly adequate job at least keeping us safe from dangerous ...

Court: Drugmakers Do Not Have To Warn Patients About Drug Risks

Jane Akre
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7/17/2012

Finger pointing, WikiCommons, Debivort July 17, 2012 ~ In a bizarre twist that puts one more advantage in the corporate side, the Supreme Court of Te…

Dr. Wei Talks (continue) Part 2

Jane Akre
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7/12/2012

On July 13, 2011 the FDA issued a Safety Communication (here) which says: FDA Safety Communication: UPDATE on Serious Complications Associated with ...

A talk with Dr. John Wei (Part one)

Jane Akre
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7/12/2012

Dr. John Wei, Urologist, University of Michigan July 11, 2012 ~ Dr. John Wei is a urologist and professor at the University of Michigan in Ann Arbor.…

Lawyer Comments on FDA's Lapdog Authority

Jane Akre
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7/12/2012

Prolift from J & J website Generally speaking, lawyers avoid talking to reporters. But in a July 10 press release (here), Henry G. Garrard III of Bla…

Hundreds of Utah Women File Lawsuits Alleging Complications for Pelvic Implants

Jane Akre
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7/9/2012

~Salt Lake Tribune, July 8, 2012 “Lee” had a pelvic mesh sling implanted six years ago to treat incontinence, which was an inconvenience. But after tw…

FDA Panel - No Decision on Metal Hips

Jane Akre
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7/1/2012

Sharee Winslow- Defective metal hip June 30, 2012 ~The U.S. Food and Drug Administration (FDA) convened an 18-member expert panel to look at the lar...

A Trip to See Dr. Raz at UCLA

Jane Akre
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6/30/2012

June 30, 2012 ~ A woman from Texas has just returned from a trip to UCLA to have an initial consultation with Dr. Raz, the surgeon who is helping so m…

J&J Continued to Sell Vaginal Mesh Implant After FDA Ordered Halt

Jane Akre
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6/27/2012

Gynecare Prolift, Medtechmarket.ru June 26, 2012 ~ Johnson & Johnson, the global healthcare company, has once again found itself in the spotlight for...

Using Vaginal Mesh as a Preventative? Study Says it's Okay

Jane Akre
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6/21/2012

June 20, 2012 ~ With all of the bad news about vaginal mesh (see Patient Profiles) and the thousands of lawsuits that have been filed by women who cl…

Coming Up: FDA Expert Panel Weighs in on Metal Hips

Jane Akre
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6/20/2012

Next Wednesday, June 27 and Thursday, June 28, the U.S. Food and Drug Administration (FDA) will convene one of its expert panels - this one on patient...

Consumer Alert- Walks Like News, Quacks Like News- Must be News? Wrong

Jane Akre
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6/19/2012

Op-Ed - June 19, 2012 ~ Editors Note- * -As someone who worked in the mainstream news for 25 years I know how it used to work. That was before the 50…

What is a Statute of Limitations?

Jane Akre
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6/14/2012

If you are considering filing a legal action, you’ve probably heard the term “Statute of Limitations.” A “statute” is the common law that sets the ti…

FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Jane Akre
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6/14/2012

Dr. Jeffrey Shuren, CDRH If you ask the public, most say they want safer medical devices, not more of them. If you ask the patients profiled in Mes...

Will the FDA Grant J&J’s Request to Stop the Studies?

Jane Akre
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6/9/2012

TVT Secur Mesh News Desk, June 9, 2012~ A few folks have asked whether or not the Food and Drug Administration (FDA) has granted Ethicon’s request to...

Will Ethicon Skirt the 522 Request?

Jane Akre
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6/8/2012

In the Ethicon June 4, announcement to two courts that it was taking four synthetic vaginal meshes off the market, Ethicon, a division of Johnson & Jo…

Four J&J Vaginal Meshes Named – Will Be Removed from Market

Jane Akre
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6/5/2012

This is an important move by mesh maker J&J - There is now more detailed information about the move by Johnson & Johnson (J&J) to stop the sale of four vaginal mesh implants.

Breaking News! Johnson & Johnson's Ethicon Plans to Pull Plug on Four Transvaginal Meshes!

Jane Akre
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6/5/2012

June 4, 2012 ~ Breaking news! Bloomberg is reporting (here) that Johnson & Johnson (J&J) has requested the paperwork to stop selling four different t…

David and Teresa Sawyer Establish Patient Advocacy Group TVTNO.org

Jane Akre
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5/31/2012

David & Teresa Sawyer of TVTNo.org May 31, 2012 ~ David and Teresa Sawyer from Curtice, Ohio faced a traumatic introduction to a medical device that...

Q & A Your turn ~ Ask me a Question, I'll Post the Answers

Jane Akre
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5/29/2012

Hello Everyone- I’m interested in starting an active Question and Answer section of this website. Are you confused by the medical jargon surrounding ...

The Patriot Ledger: Boston Scientific Faces Nearly 300 Mesh Implant Complication Lawsuits

Jane Akre
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5/29/2012

May 29, 2012 ~ According to an article published in The Patriot Ledger, Boston Scientific was sued in Boston federal court May 2, by Sheila Roach of M…

Litigation: Vaginal Mesh Status Conference May 2012

Jane Akre
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5/28/2012

May 27, 2012 ~ The Honorable Judge Joseph R. Goodwin is overseeing all four vaginal mesh MDLs (multidistrict litigation) in his U.S. District Court f…

Family Tree of Meshes from The Female Patient, April 2009

Jane Akre
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5/28/2012

If you find it difficult to understand all of the different types of synthetic transvaginal mesh, this graphic from The Female Patient, April 2009 may…

Changes in Female Sexual Function Following TVM Surgery

Jane Akre
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5/28/2012

May 27, 2012 ~ What’s interesting is that the comparison of female sexual functioning following transvaginal mesh surgery has never been reported befo...

Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

Jane Akre
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5/25/2012

May 24, 2012 ~ The U.S. Food and Drug Administration (FDA) is one step closer to being funded for the next five years in a bi-partisan vote considered…

Pelvic Mesh: A Story of Social Injustice in Public Health

Amy Gezon
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5/25/2012

*Editors Note * Amy Gezon allowed me to reprint this story that appeared in Yahoo News. I met Amy at the FDA hearing on mesh in September 2011 and we've been friends ever since. She survived mesh.

Politico Ad: Consumers Union Warns the FDA Cannot Protect Patients

Jane Akre
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5/22/2012

May 22, 2012 ~ The U.S. Food and Drug Administration (FDA) has as its mission the protection of the American people from dangerous consumer products ...

Suffering in Silence: Nonie Wideman ~ Canadian Child Advocate and Rancher Sidelined By Transvaginal Mesh

Jane Akre
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5/21/2012

Rancher, Canadian Nonie Wideman might be considered one of those angels on earth who pays it forward by taking into her home kids with all sorts of special needs. Now she's advocating for mesh injured

FDA Closer to Funding Goals – Where is Patient Safety?

Jane Akre
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5/15/2012

On May Tuesday, May 8, a House subcommittee unanimously voted to approve its version of the Medical Device User Fee Act (MDUFA) which funds the U.S. ...

America Now: Routine Surgery Dangerous for Women

Jane Akre
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5/14/2012

May 14, 2012 ~ The syndicated show, America Now, ran a story last week on Teresa Sawyer of TVTNo.org and also the subject of a Patient Profile in MDN…

ProPublia: Four Medical Devices that Bypassed FDA Scrutiny

ProPublica
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5/10/2012

ProPublica, an independent journalism organization, reports on four medical devices that are among the thousands pushed into the market annually with very little scrutiny.

Toronto: Globe and Mail on Risks of Surgical Meshes

Jane Akre
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5/9/2012

The Toronto, Canada newspaper, The Globe and Mail, on May 7, Monday night published, “Time to discuss risks of surgical meshes.” These are embarrassi…

Let the Trials Begin - C.R. Bard

Jane Akre
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5/7/2012

Bard Avaulta from website May 7, 2012 ~ The date has been set - February 5, 2013 will be the first of what promises to be a series of federal court...

NPR: Why People Do Bad Things

Jane Akre
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5/1/2012

May 1, 2012 ~ National Public Radio ran a podcast of an interesting topic, Why People do Bad Things. We often find that executives within a company or…

New J & J CEO Plans to Expand Medical Device Industry

Jane Akre
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5/1/2012

It will be interesting to watch how Alex Gorsky, 51, handles his new job and all that comes with it. As of April 26, he is in charge of Johnson & Jo...

Couple Finds No-Mesh Hernia Repair Doctor in Fresno

Jane Akre
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4/30/2012

…

History in the Making Petition by Meshies United UK Group

Jane Akre
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4/30/2012

Petition Delivered to 10 Downing Street I would like to introduce myself. My name is Teresa Hughes The Owner and Founder of The Meshies United Group...

The Future of Mesh Sales is Rosy Says Market Research Group

Jane Akre
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4/26/2012

April 24, 2012 ~ Even though the number of lawsuits against synthetic mesh manufacturers is growing by the day, surgical mesh products are expected to…

Canadian Courts Take Aim At Ethicon

Jane Akre
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4/23/2012

April 23, 2012 ~ The case against Johnson & Johnson, Ethicon, and Ethicon Women’s Health and Urology and Gynacare was filed in Ontario Superior Court ...

Suffering in Silence: Mary Blanks Not Silent Anymore About Transvaginal Mesh Sling

Jane Akre
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4/23/2012

“I’m a pretty smart cookie. I’ve tested genius, but trust me I’m at half capacity.” So says 58-year-old Mary Blanks of Erie, Pennsylvania. The Method…

Michigan Lawmaker Wants FDA Promoting Jobs, Industry

Jane Akre
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4/20/2012

April 20, 2012 ~ Ask most Americans and they would say that the role of the U.S. Food and Drug Administration (FDA) is to protect us from unsafe food...

CTV - Canadian Transvaginal Mesh Class Action Lawsuit

Jane Akre
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4/18/2012

April 17, 2012 ~ CTV National News on Tuesday, April 17, ran a taped story of two women who are involved in a multimillion dollar class action lawsui…

Lead Counsel Chosen in Transvaginal Mesh Cases

Jane Akre
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4/13/2012

Friday, April 13, 2012 ~ This morning the lead attorneys were chosen who will represent the transvaginal surgical mesh product liability cases consoli...

Lead Attorneys to be Chosen in Transvaginal Mesh Cases Friday, April 13

Jane Akre
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4/13/2012

The Honorable Judge Joseph Goodwin The Honorable Judge Joseph Goodwin will oversee a hearing Friday, April 13, to decide who will be the lead attorne…

Beverly's Lunch and Learn for Meshies

Jane Akre
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4/12/2012

April 12, 2102 ~ Beverly Martiniano has a good idea. Start a Lunch and Learn Meeting for Meshies group- advertise on Craigslist or Tweet- use social...

Patient Advocate Presence at FDA Workshop on Future Funding

Jane Akre
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4/9/2012

July 13, 2012 ~ The FDA is eager to secure funding from the medical device industry to fund reviews for the next five years. Industry funds about 20 p...

American Medical Systems Files its Position Statement Laying Out its Strategy in Court in Defective Mesh Lawsuits

Jane Akre
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4/9/2012

April 9, 2012 ~ On Friday, April 6, American Medical Systems Inc. (AMS) of Minnetonka, Minnesota filed its Position Statement with federal court in t…

Dr. Goldman Talks Mesh Removals

Jane Akre
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4/5/2012

Dr. Howard Goldman, Cleveland Clinic A woman who I am planning to do a Patient Profile on called me the other day. She had surgical mesh partially re…

Kathleen: Questions to Ask Before Mesh Removal

Jane Akre
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4/2/2012

Mesh after removal 'Kathleen' (not her real name which she doesn't want to use because of litigation) is a regular reader of MDND and has some sugge...

David Sawyer: Getting Organized and Looking for Help After Mesh Sling Implant

Jane Akre
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4/2/2012

David & Teresa Sawyer As most of you know Teresa and I have been devastated by this product and still Teresa is looking at a minimum of 1 maybe 2 mor...

Consumer Reports: Dangerous Medical Devices

Jane Akre
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4/2/2012

April 1, 2012 ~ The May issue of Consumer Reports (here) features an investigation into synthetic mesh and artificial hips - medical devices that es…

FDA Expert Panel to Assess Metal Hips

Jane Akre
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3/30/2012

The FDA has scheduled a two-day expert panel review of metal-on-metal hips as concerns mount about patient injuries. The June 27-28 gathering (locati…

Beverly Martiniano: Suffering in Silence and Waiting Until October

Jane Akre
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3/28/2012

Cousin Julia and Beverly Martiniano October 1, 2012 is an important day for Beverly Martiniano. It’s her 65th birthday, yes. But it is also the day s…

What to Understand Pre-mesh: Graphic Videos of Mesh Removal and Sling Incision Treatment

Jane Akre
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3/27/2012

The Cleveland Clinic is renowned for some pretty innovative procedures and reputable doctors. Among them, Dr. Howard Goldman provides video demonstra...

Johnson & Johnson Began Phasing out DePuy Defective Hip Prior to Recall

Jane Akre
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3/23/2012

March 23, 2012 ~ This has not been a good week for Johnson & Johnson. First word that it sold the transvaginal surgical mesh, ProLift, without gettin...

Call to Action: Citizens Lend Support to Sound Devices Act

Jane Akre
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3/21/2012

March 23, 2012 ~ The SAFETY OF UNTESTED AND NEW DEVICES (SOUND DEVICES) ACT OF 2012 is a critical step to stop others from being harmed by untested, u...

Breaking News ~ J & J Sold Vaginal Mesh Implant Without FDA Approval

Jane Akre
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3/21/2012

March 21 ~ Bloomberg is reporting (here) that major medical device maker Johnson & Johnson (J&J) sold the Gynecare Prolift surgical mesh for three ye…

Politics Gives a Pass to Negligent Doctors, Drug and Device Makers

Jane Akre
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3/20/2012

March 20, 2012 ~ The advocacy group, Public Citizen in a letter (here) to Congress issued Monday, March 19 calls on the U.S. House to Reject the medic…

Sick of Suffering in Silence

Jane Akre
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3/20/2012

MARCH 19, 2012 ~ By Jane Akre A story before I tell this story. I was commissioned to write a 2,100 word piece for the Chicago-based magazine "In ...

Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure

Jane Akre
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3/15/2012

March 7, 2012 ~ The Union of Concerned Scientists (USC) issued the results of a survey released today of 977 Food and Drug Administration scientists. …

Consumer Reports Campaign email Alerts Million About Defective Medical Devices

Jane Akre
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3/13/2012

MARCH 12, 2012 ~ How bad are medical devices approved by the U.S. Food and Drug Administration? Reuters reports (here) that Consumer Reports believes ...

Why I am Disgusted with Everything Mesh!

Jane Akre
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3/9/2012

*Editors Note: “Betty” wrote this opinion piece. She is a woman who is represented by a lawyer who does not want her speaking up but she still wants t…

When Surgery is Needed Now and Litigation is Pending

Jane Akre
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3/9/2012

Mark Bello, of Lawsuit Financial Corp, Farmington Hills, Michigan has been a trial lawyer for 35 years, spending the past 13 of those operating a ful...

FDA Denies Legal Group Seeking to Ban IOM Recommendations

Jane Akre
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3/8/2012

March 7, 2012 ~ Bloomberg BNA reported (here) that the Washington Legal Foundation (WLF), had its petition rejected by the Food and Drug Administratio…

Australia's Version of FDA Lax on Medical Device Safety

Jane Akre
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3/7/2012

With the global news about the defective French breast implants called PIP filled with industrial silicone, the Canberra Times (here), published in t...

Suffering in Silence: Howard Sadwin’s Story of Metal-on-Metal Hip Failure

Jane Akre
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3/6/2012

Howard Sadwin is 65 years old and lives in Sarasota, Florida. Life has not been the same since a metal-on-metal hip implant in 2007. In fact, during …

Hernia Repair: Secrets Patients Should Know

Jane Akre
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3/2/2012

The Wall Street Journal’s Laura Landro writes about hernia repair and the secret patients should ...

Jim Shull- Observations on How Lawmakers View Medical Device Regulation

Jane Akre
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2/22/2012

Jim Shull testifies February 22, 2012 ~ Jim Shull was a member of a patient advocacy group when in October of 2008, the Food and Drug Administration,…

Hernia Mesh Injured Patient Jim Shull Testifies on FDA's Lax Oversite of Medical Devices

Jane Akre
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2/17/2012

Jim Shull February 15, 2012 ~ Testimony of James Shull U.S House Committee on Energy and Commerce/Subcommittee on Health My name is Jim Shull and I a...

Metal Hip Device Implant Sold in EU After Rejected in U.S.

Jane Akre
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2/16/2012

February 15, 2012 ~ Barry Meier of the New York Times reports that Johnson & Johnson’s DePuy division continued to sell a defective artificial hip ov…

FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

Jane Akre
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2/15/2012

February 14, 2012 ~ What is MDUFA? The Medical Device User Fee and Modernization Act shortened from MDUFMA. Enacted in 2002 and again in 2007 it auth...

Where Are the Postmarket Surveillance Plans for POP, SUI Mesh?

Jane Akre
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2/14/2012

February 14, 2012 ~ Where's the Plan? On January 3, 2012, the FDA sent out copies of a 522 order to 33 manufacturers of synthetic surgical mesh for pe…

Call to Action This Week!

Jane Akre
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2/13/2012

Call to Action The stories in Patient Profiles show something within the FDA is clearly broken, and needs to be fixed. Most blame the 510(k) process w…

Must Watch Live Feed: Hearings on Mesh, Medical Device Budget Pits Patient Safety v. Industry

Jane Akre
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2/13/2012

A must watch show How to Watch: Go to www.energycommerce.house.gov (link will show up when gavel begins hearing, live feed) Hearing: "Reauthoriza…

Call to Action - House Energy & Commerce Committee Hearings on Mesh

Jane Akre
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2/13/2012

House Democrats are asking Republicans for a hearing on Johnson & Johnson synthetic surgical transvaginal mesh used to treat pelvic organ prolapse, ...

Lorraine Evans Highlights Global Problem of Mesh Mess

Jane Akre
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2/13/2012

Press Release For Immediate Release: Monday, February 13, 2012 End our ‘human guinea pig’ hell A TIRELESS campaigner (from the UK) is calling on surge...

Industry Says EU Medical Device Sales Healthy, Silicone Scandal May Change That

Jane Akre
|
2/11/2012

February 10, 2012 ~ A survey by a medical device consultant, Emergo Group, released Friday, (news release here) February 10, finds that overseas sales...

Consumers Union on Improving the Safety of Medical Devices

Jane Akre
|
2/9/2012

Improve the safety of medical devices An overview of Consumers Union’s Safe Patient Project Initiative Medical devices, like eyeglasses and contact...

Industry Doesn’t Want Medical Device Tax, GOP Freshmen Help

Jane Akre
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2/9/2012

An article in DOTmedNews reports that GOP freshmen are aligning with industry to oppose a 2.3 percent excise tax on the medical device industry set t…

Sen. Grassley Comes to Defense of One Whistleblower in Letter to Hamburg

Jane Akre
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2/8/2012

February 9, 2012 ~ “Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so while risking their professional car…

140 Mesh Injury Lawsuits to be Consolidated in 3 MDLs in West Virginia

Jane Akre
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2/7/2012

February 7, 2012 ~ Breaking News! Within the hour the Judicial Panel on Multidistrict Litigation (MDL) ruled that three pending and separate MDL ac...

Consumers Union's Safe Patient Project Brings Eight Activists to Congress

Jane Akre
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2/7/2012

CU's Safe Patient Project February 6, 2012 ~ Consumers Union is bringing eight patient activists to Washington, D.C. to meet with lawmakers and press...

Hernia from Hell Treated with Biologic Mesh

Jane Akre
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2/7/2012

Story in Sarasota Herald-Tribune February 6, 2012 ~ James Fico had a problem. The Sarasota Herald-Tribune (here) reports on the North Port man’s bask…

Device Maker Smith & Nephew Pays $22 Million to Settle Bribery Case

Jane Akre
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2/6/2012

Medical device maker, Smith & Nephew has been in the news lately as one of the manufacturers of metal-on-metal artificial hips. Now AP (here) reports …

Sheri Ragan Still Suffering from Biologic Hernia Mesh

Jane Akre
|
2/3/2012

Sheri Ragan Sheri Ragan is playing the waiting game - waiting for a hospital in Ormond Beach, Florida to decide when and if it will take Medicaid so ...

Sound Medical Devices Act- Dems Want FDA to Block Approvals When Similar Device is Recalled

Jane Akre
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2/2/2012

February 1, 2012 ~ Bloomberg reports on a bill introduced this week that would put the brakes on the approval of a medical device that claims to b…

Medical Device Makers Will Double Fees for Faster FDA Reviews

Jane Akre
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2/1/2012

Medical device makers want to get their products into the marketplace faster. The U.S. Food and Drug Administration (FDA) needs more operating capit...

FDA Whistleblowers Sue Agency, Claim Retaliation Over Unsafe Medical Device Revelations

Jane Akre
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1/31/2012

January 30, 2012 ~ What’s going on inside the FDA? Six of the “FDA Nine” whistleblowers are suing the agency for illegally spying on their private ema…

Toys from China and Medical Devices Share Scrutiny in EU

Jane Akre
|
1/28/2012

Many in the United Kingdom assume that an implanted medical device is reviewed for safety before it is permanently placed inside a patient. They woul...

Showdown in House Hearings Over Mesh, Medical Devices

Jane Akre
|
1/24/2012

January 23, 2012 ~ House Democrats are asking Republicans for a hearing on Johnson & Johnson synthetic surgical transvaginal mesh used to treat pelv…

FDA Misses Deadline to File Financials for Review

Jane Akre
|
1/24/2012

The U.S. Food and Drug Administration (FDA) was supposed to submit a new agreement to lawmakers on January 15, concerning how much funding it will n...

New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

Jane Akre
|
1/20/2012

January 19, 2012 ~ In a letter to the Editor of the New England Journal of Medicine (NEJM), (here) January 19, 2012, Neil Feder, M.D. of the Project…

Covidien Recalls Surgical Staples After 3 Deaths

Jane Akre
|
1/18/2012

January 16, 2012 ~ Medscape Medical News (here) reports that medical device maker Covidien is voluntarily recalling surgical staples used in endoscop...

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