Archives

1/10/2012

The front-page headlines in Europe concern substandard and defective breast implants made by the French company Poly Implants Protheses (PIP), made with machine grade silicone.

Mesh Makers Who Received FDA Letter Requiring Postmarket Surveillance

1/10/2012

JANUARY 9, 2012 ~ The following is a list of the companies who received the letters from the Food and Drug Administration (FDA) January 3, 2012, requ…

FDA Orders Manufacturers to Study Mesh Complications

1/6/2012

Prolene mesh JANUARY 4, 2012 ~ Bloomberg reports that the Food and Drug Administration's division that oversees medical devices has ordered surgical ...

Suffering in Silence: Athlete Pat Buchanan Faces Her Biggest Competitor Yet

1/6/2012

An Athlete's Challenge with Surgical Mesh Patricia Buchanan, 61, a widow and triathlete from Whidbey Island outside of Seattle, was training for the…

Netherlands Newspaper Investigates Mesh Mess

12/29/2011

DECEMBER 29, 2011 ~ The Netherlands will begin a patient registry of synthetic gynecological mesh in early 2012 requiring gynecologists to report th...

Op Ed: David Sawyer on Caring After a Medical Device Nightmare

12/26/2011

As I reflect back on the last year I feel it is in order to share many things with those of you who have cared and loved us. I sat today looking back…

Former FDA Director Joins Public Citizen in Device Recall Petition

12/24/2011

DECEMBER 23, 2011 ~ The consumer group Public Citizen frequently calls for the recall of dangerous drugs or medical devices including a petition last...

Plaintiffs Want Mesh Lawsuits Centralized

12/22/2011

Scales of Justice, WikiCommons DECEMBER 22, 2011 - The Athens Georgia law firm of Blasingame, Burch, Garrard & Ashley, P.C. has filed a motion to ha…

Physician Confidence in Mesh Shaken, Sales Projected to Improve says Market Research Group

12/22/2011

DECEMBER 22, 2011 - This projection by the Toronto-based Millennium Research Group (MRG) says some doctors report they lack confidence in the current...

No Easy Solution to Removing Mesh

12/20/2011

The topic of removing mesh has become problematic. Not only should Mesh News Desk not recommend any doctor to remove mesh, (we didn't) but there has …

More Monitoring of Medical Device Implants After Market

12/18/2011

Artificial hips that fail, surgical mesh that injures - the New York Times reports (here) on December 14, 2011, that amid the growing number of probl...

Medtronic Pays $23 Million to Settle Doctor Kickback Charges

12/18/2011

Medtronic is the world’s top maker of medical devices and it didn’t get that way without help. The U.S. Department of Justice accused the Minnesota-…

Anonymous: While I'm Still Speaking Out

12/13/2011

Why I do this One thing that is hurting women is the letter they get from Lawyers telling them to not speak. It is written in a way that the whole wo...

FDA and Med Device Makers Make it Official

12/8/2011

by Jane Akre// DECEMBER 7, 2011 //Shuren Signs Memo of Understanding// Minnesota loves its medical device industry. Even Senator Al Franken (D-MN) wh…

Media Update on David & Teresa Sawyer

12/8/2011

A Gannett co. newspaper, The News-Messenger reports on David and Teresa Sawyer, the couple we profiled here earlier this summer. Their story is here....

Industry Influence - Lobbying Doesn't Come Cheap

12/6/2011

AdvaMed Advanced Medical Technology Association or AdvaMed (here) calls itself the world’s largest medical technology association. In other …

FDA: Recalled Medical Devices for 2011

12/6/2011

The FDA announced its Recalled Medical Devices for 2011 December 6th, Tuesday. The Recall Classifications are divided into three classes according to ...

Linda Dodson: Suffering in Silence no Longer after Mesh and Medical Mishaps

12/1/2011

Twin sisters Linda Dodson and Brenda Mann Jones Linda Dodson, a dark-haired, attractive Georgia peach with a long southern drawl to match decided to …

What Do You Want?

11/28/2011

I've been working with a very smart 29-year old web person (who unfortunately has to try to teach this old dog new tricks), but she understands web c...

More Media on Medical Devices, Money and Prison Time

11/28/2011

Three medical device executives are going to prison for the death of three patients who were subjected to an experimental bone cement they produced. …

Merck’s Blockbuster Vioxx Settlement

11/23/2011

NOVEMBER 22, 2011-When a defective product has harmed so many people and cost so many lives, the settlement numbers are huge too. Now the U.S. Just…

X-Rated, Misbranded Medical Device Winner a Loser

11/23/2011

This true story will help you enjoy your holiday. Not to have a laugh at someone else’s expense, but when they are so wrong, why not? In this case a M...

Suffering in Silence: Hal Samples' Years of Pain Following Mesh Hernia Repair

11/21/2011

Hal Samples and friends Mesh Medical Device news Desk, November 21, 2011 ~ Dallas photographer and artist, Hal Samples’ name is synonymous with the …

Mesh-Injured Patient Researches ProteGen Mesh Predicate

Suzanne McClain

11/18/2011

Suzanne McClain shares her research with readers on ProGen mesh. Editors Note* - I first interviewed Suzanne McClain, 45, in March 2009 and she became part of the series of reports for Injuryboard

Can the FDA Promote Innovation and Protect Patients?

11/17/2011

Jeff Shuren MD Mesh News Desk, November 7, 2011 ~ CDRH Shuren Defending FDA Against Harsh Industry Critics Dr. Jeffrey Shuren, director of the FDA's …

Want to Reclassify a Medical Device? The FDA is all Ears

11/15/2011

The Food and Drug Administration on Monday, November 14, announced it will receive public comment on whether or not a medical device should be reclass...

To Whom Have You Reported Your 'Adverse Event' ?

11/14/2011

I have a question - Assuming you've had a problem with synthetic surgical mesh, who have you reported your complications to? The manufacturer, the …

Media Reports on Money, Muscle, and Medical Devices

11/14/2011

NOVEMBER 14, 2011 - Former Saturday Night Live comedian turned U.S. Senator, Al Franken represents Minnesota and with Minneapolis a hub of the medic…

Do No Harm Applies to Medical Software, Says IOM

11/12/2011

Mesh News Desk, November 11, 2011 ~ The Institute of Medicine (IOM) shook the public and the medical establishment in 1999, with its landmark study “T...

Did Medtronic Sell an Unsafe Product?

11/12/2011

NOVEMBER 12, 2011 - Fridley, Minnesota is home to Medtronic, the largest medical device company, and an article in the Star Tribune, November 12, Sat...

Jeff Silverman: Suffering in Silence Over Hernia Mesh Pain

11/12/2011

Silverman is one of many men who finds himself disregarded. Not only do medical doctors not believe his pain following a mesh implant to treat a her…

First Canadian Transvaginal Mesh Case Filed

11/9/2011

NOVEMBER 9, 2011 - The first of many more expected lawsuits was filed this week in Canada in the Ontario Superior Court of Justice naming defendant ...

FDA: Medical Device Complications Growing Faster than Industry

11/8/2011

Understanding Barriers to Medical Device Quality is the name of an FDA report issued October 31 by the Center for Devices and Radiological Health (CDR…

Markets for Newer Vaginal Slings and Pelvic Floor Reconstruction Devices to Show Significant Declines, MarketWatch, Press Release by Millennium Research Group, November 7, 2011

11/7/2011

According to a report issued today, November 7, by Millennium Research Group (MRG), the market for pelvic floor reconstruction vaginal slings is pre...

Get the Mesh Out! Doctors React to Patients Following FDA’s July Warning about Surgical Mesh

11/5/2011

Last July 2011 when the U.S. FDA issued its most strongly warning notice yet about complications associated with the use of pelvic mesh, doctors began to hear from their patients en masse.

Dr. Ostergard on Degradation, Infection and Heat Effects on Polypropylene Mesh

11/2/2011

Donald R. Ostergard, MD, has had a long distinguished career in urogynecology and reconstructive pelvic surgery. He is also a founding member of AUGS.

Suffering in Silence: Jane Dowdall - Life After Prolapse Bladder Surgery with Synthetic Mesh

10/31/2011

Jane Dowdall, 55, is from Ontario, Canada and tells her own story of bladder prolapse repair and her life today. "In early 2009, I was referred to ...

Spokesmodel for Hip Replacement Sues Device Maker, J&J

10/31/2011

OCTOBER 31, 2011 - She is a former gymnast turned spokesmodel for DePuy who has joined in a lawsuit against the device maker, Johnson & Johnson, aft…

A Pelvic Organ Anatomy Lesson 101

10/28/2011

Pelvic Organ Prolapse is explained in this You Tube video (click here). The video clearly shows a 3-D animation of the female anatomy which is well …

Three Lawsuits Join Hundreds

10/25/2011

Boston Scientific Pinnacle Pelvic Floor Repair Kit Lawsuit Filed According to a story in About Lawsuits.com, a woman from Louisiana has filed a lawsu...

Mesh / Medical Device News Desk

10/19/2011

Thanks for stopping by. Many years from now the public will probably look back and say “They put permanently implanted medical devices in people with...

Designer Vaginal Surgery: Snip, Stitch, Kerching!, The Guardian, October 14, 2011

10/19/2011

This story published in The Guardian really makes you wonder whether or not female genitalia is synonymous with pure cash. At a five-star golf resort …

Q & A

10/19/2011

I'm Jane Akre, the News Editor at Mesh / Medical Device News Desk and I'm here to help and to put a face on the devastating injuries that women and ...

As Lawsuits Amass So Do Solicitations

10/18/2011

by Jane Akre, OCTOBER 18, 2011 - Ever since the U.S. Food and Drug Administration issued its July 13th notification that complications from the impla…

Money and Medical Devices - Not Even a Whistleblower Can Stand in the Way

10/13/2011

OCTOBER 12, 2011 - MassDevice (here) reports on the firing of Dr. Nalini Rajamannan, an associate professor of medicine at Northwestern University, …

Latest Legal News - A Surge in Avaulta Claims May Consolidate

10/13/2011

U.S. District Court, Charleston, West Virginia OCTOBER 13, 2011 - Hundreds of lawsuits against medical device maker, C.R. Bard, have been filed and t...

Liz Reece: Suffering in Silence Until "Angel" Doctor Removed Surgical Mesh

10/11/2011

Liz Reece is a 48-year-old woman from Oxfordshire, United Kingdom who had a mild case of incontinence. “I went into an Oxford hospital’s pelvic clinic…

A Surge in Avaulta TVM Claims and Reclassification, Lawyers and Settlements, October 6, 2011

10/6/2011

Lawyers & Settlements reports more than 600 lawsuits have been filed against two of the largest synthetic surgical mesh manufacturers - Johnson & John...

How to Speed Up Approval of Medical Devices?

OCTOBER 3, 2011 - How to speed up the approval of a medical device that cannot claim it is substantially similar to one already on the market under…

Suffering in Silence: Denise Jacobs on Surgical Mesh "an unreasonable and substantial risk of illness or injury"

By DENISE JACOBS, CRNA, ARNP SEPTEMBER 9, 2011 Dear Dr. Shuren, Dr Lerner, CDRH members, and Obstetrics and Gynecology Medical Devices Panel, Thank ...

WHO ATTENDED: September 8-9, 2011 FDA Public/ Expert Meeting on Medical Devices for Obstetrics and Gynecology

Synthetic surgical mesh has been on the hot seat of late after a 2011 FDA warning said mesh complications are "not rare," a reversal from an earlier FDA position.

Op-Ed: Where Facts Are Few, Experts Are Many, by Amy Gezon

Amy Gezon

Where Facts are Few, Experts are Many: The rise of synthetic mesh for the treatment of stress incontinence during an era of bad science.- Amy Gezon …

Suffering in Silence: Amy Gezon Tells FDA Panel Boston Scientific Mesh Sling Devastated Her with Pain

9/29/2011

Amy Gezon is a 43-year-old mother of 3 from Salt Lake City, Utah and the wife of an emergency room doctor at the VA medical center. She studied nursi...

Dr. Susan Lark: Undoing Urinary Incontinence

9/26/2011

Dr. Susan Lark is author and women’s health specialist who combines clinical nutrition with preventive medicine and complementary therapies to enhance...

The Next Medical Device Controversy: Vaginal Mesh, Business Week, September 15, 2011

9/26/2011

Business Week reports on The Next Medical Device Controversy: Vaginal Mesh Marci Sutin Levin, a 65-year-old New York marketing executive says she can’…

Suffering in Silence: Jacqui Gibson's Encounter with Ethicon in Western Australia

9/22/2011

Jacqui Gibson, husband and son from Western Australia Jacqui Gibson, 44, of Perth, Australia says her story is like many others. Three years ago she …

Two Studies on Mesh Offer Questionable Outcomes of Success

9/20/2011

Two Published Studies - Consider Your Odds SEPTEMBER 20, 2011- Two studies on the use of synthetic mesh for female stress urinary incontinence treatm...

Wall Street Journal- Venture Capital Dispatch, Sept. 15, 2011

9/16/2011

The Push from Venture Capital Investors Venture capital investors are keeping a close eye on the FDA, especially since the way it approves medical dev…

Suffering in Silence: Diane Maassen Tells FDA Panel About Her Nightmare with Pelvic Mesh Sling

9/16/2011

SEPTEMBER 16, 2011 - Editors Note: I attended the Food and Drug Administration expert panel convened on September 8 & 9, 2011 to listen to patients ...

Boston Scientific Hires Former J & J Exec Involved with Defective Recalled Hip Device, Mass Device, CBS News, September 14

9/15/2011

Boston Scientific New President from J & J Boston Scientific Corporation of Natick, Mass. announced it will have a new president on October 17. He is…

Former FDA Director Joins Consulting Company as President, Market Watch, September 14

9/14/2011

Is this the revolving door? Ron Johnson, former Director of the Office of Compliance within the Center for Devices and Radiological Health (CDRH) of t...

FDA Panel Wants More Data on Mesh Tx for Incontinence, MedPage Today, September 9

9/13/2011

MedPage Today (here) reports an FDA advisory panel meeting over synthetic mesh used to treat stress urinary incontinence (SUI) said it would like mo…

J & J–Led Vaginal Mesh Group Says FDA Should Require More Studies, Bloomberg, Sept 8, 2011

9/13/2011

This article in Business Week (here) reports that medical device makers attending a September 8 & 9 panel of experts convened by the Food and Drug A...

FDA Gears Up for Synthetic Mesh Regulation

9/11/2011

SEPTEMBER 10, 2011 - Should synthetic mesh used to treat stress urinary incontinence be upgraded to a Class III high risk device? The Food and Drug A…

Push to More Regulation Heats Up FDA Expert Panel on Surgical Mesh

9/9/2011

SEPTEMBER 8, 2011 - About the only thing that the room full of injured patients, industry representatives, and surgeons could agree on at the first FD...

No Recall for Breast Implants, FDA says, Mass Device, September 1, 2011

Despite the fact that there are no long-term safety data, the FDA announced there will be no recall for silicone breast implants. That announcement wa…

FDA: Breast Implant Safety Studies Will Continue, Web MD, August 31, 2011

Web MD reports the current post-approval studies on silicone-gel implants will continue according to the FDA’s Center for Devices and Radiological Hea...

Medical device software criticized as under-regulated, Los Angeles Times, September 1, 2011

The Los Angeles Times reports today’s medical devices are governed by “software” that is the electronic component that governs everything from pacema...

Is the FDA Killing Innovation? Fortune, September 2, 2011

CNN reports on MelaFind, a handheld medical device that helps doctors spot melanoma using a noninvasive computer imaging. But it is still not approve…

LATEST FDA REPORT: Classify Surgical Mesh Devices for Pelvic Surgery as High Risk Class III

9/1/2011

If a U.S. Food and Drug Administration (FDA) staff report is adopted, synthetic surgical mesh manufacturers such as Boston Scientific and J&J may have to submit safety data.

Gateway FDA: The New 510 (k) Guidance: A Product Liability Perspective, Gateway FDA, August 26, 2011

8/26/2011

This August 26, 2011 blog on Gateway FDA is written for the medical device industry and its lawyers. The FDA recently issued new draft guidelines so m…

Pelvic Surgeon Dr. M. Tom Margolis on 'Getting the Mesh Out'

8/26/2011

As a Pelvic Surgeon/Urogynecologist, Dr. Margolis helps women suffering from incontinence, pelvic organ prolapse and a variety of surgical problems ...

Public Citizen: Recall Synthetic Surgical Mesh

8/25/2011

AUGUST 25, 2011 - Synthetic surgical mesh is implanted into women for the treatment of pelvic organ prolapse and incontinence and now Public Citizen …

Study Halted Due to Mesh Complications

8/21/2011

This study, Vaginal Mesh for Prolapse: A Randomized Controlled Trial, was published in the August 2010 issue of the journal, Obstetrics & Gynecology....

Suffering in Silence: Jim Shull from Synthetic Bard Hernia Mesh

8/17/2011

Lisa and Jim Shull Jim Shull’s story started in September 2005. He had passed a kidney stone and went to see a urologist who ordered a CT scan to see…

Changes Are Afoot in U.S. Medical Device Regulations, Morningstar, August 15, 2011

8/15/2011

This excellent article by Morningstar reminds us that the Food and Drug Administration (FDA) has been reviewing the regulatory process that allows mos…

Brevard Women Sue Over Mesh Devices, Florida Today, August 9, 2011

8/15/2011

Florida Today reports that while the FDA considers tougher regulations over medical devices, that decision will come too late for four women from Brev...

Study of Medical Device Rules Is Attacked, Unseen, New York Times, July 27, 2011

8/14/2011

Allies of the medical device industry criticized an Institute of Medicine report, to be released July 29, that says the approval process for a wide ra…

U.S. Advisers Call for New Medical Device Regime, Reuters July 29, 2011

8/14/2011

The FDA is pushing back on an Institute of Medicine recommendation that the fast-track approval process for medical devices is fatally flawed and sho...

FDA seeks more industry opinion about Device approval process, Star Tribune, August 2, 2011

8/13/2011

The medical device industry is very concerned following an Institute of Medicine report that the fast-track system for getting devices on the market should be abolished.

510(k) Reform: Minnesota Congressional Delegation Lines up in Opposition, Mass Device, August 3, 2011

8/11/2011

Sens Amy Kloubechar (D-Minn.), Al Franken (D-Minn.) and Rep. Erik Paulsen (R-Minn) reject calls by the Institute of Medicine to kill the 510(k) program from Minnesota a hub for that industry.

Suffering in Silence: Janet Holt

8/11/2011

Janet Holt, 54, has lived on a Floresville, Texas cattle ranch with her husband for 20 years. The couple saved and scrimped over the years to open a …

FDA Warns of Symptoms of Mesh Problems

8/10/2011

After initially calling problems with synthetic surgical mesh, “rare” the Food and Drug Administration did an about-face and said complications were "not rare" which led to a POP mesh ban.

How Safe Are Medical Devices?, New York Times, August 4, 2011

8/5/2011

This Opinion Page Editorial in the New York Times reports the "substantial equivalent” standard of the 510(k) process doesn't work because some devic…

Suffering in Silence: David and Teresa Sawyer

8/5/2011

“You can’t believe how a little piece of mesh can change your life” says David Sawyer about the operation his wife had in February, 2011. During surg...

FDA Calling for Public Input into 510 (k) by Sept. 30 Deadline

8/4/2011

Following the release of a controversial new report from the Institute of Medicine on how medical device are cleared for marketing, in many instances …

Shuren to MN device industry: Reviewers will undergo training, MedCity News, August 3, 2011

8/3/2011

Minnesota is a mecca for medical device manufacturers, so Dr. Jeffrey Shuren, who heads the device division of the FDA visited there after an IOM public criticism of 510(k) device approval process.

FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of pelvic Organ Prolapse and Stress Urinary Incontinence

8/2/2011

FDA Public Health Notification: October 20, 2008. Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of pelvic Or...

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.

7/31/2011

This is the second notice issued by the FDA on the complications association with synthetic surgical mesh. This one, issued July 13, 2011, says: "S...

Medical Device Approval “Fatally Flawed"

7/29/2011

In a major red flag, the Institute of Medicine (IOM) says the Food and Drug Administration’s (FDA) process for clearing medical devices and protecting…

Report Urges New Review System for Medical Devices, U.S. News and World Report, July 29, 2011

7/29/2011

This report, in U.S. News and World Report, says about 90% of the 4,000 applications for new medical devices through 510(k) are approved and reach th...

Risky Pelvic Mesh Highlights Worries about FDA Process, MSNBC, July 26, 2011

7/26/2011

MSNBC reports on Janet Holt, 54, who underwent surgery for pelvic organ prolapse four years ago, and today reports "the medical device that was suppo…

FDA warns against surgical mesh to repair pelvic problems, Boston Globe, July 13, 2011

7/13/2011

The Boston Globe reports Wednesday, July 13, that women who have vaginal surgery to fix pelvic organ prolapse may suffer more risk than benefit. Quoti...

FDA: CDRH Plan of Action on 510(k), June 15, 2011

6/30/2011

This FDA Plan of Action (here) outlines 25 specific actions and accompanying timelines to make the 510(k) program “a blueprint for smarter medical d…

Mesh Makers Want Non-Pennsylvania Plaintiffs Out of Philadelphia Court

Lack of personal jurisdiction- J&J’s Motion to reconsider order denying motion to dismiss and ”Preliminary Ojbections for lack of personal jurisdictio...

J&J Medical Expert - No Problems with TVT-SECUR

Dr. Janet Tomezsko, expert for J&J Mesh Medical Device News Desk, September 1, 2017 ~ Dr. Janet Tomezsko, August 28, 2017 Afternoon session, the Def…

Washington Post Tackles Vaginal Mesh

Mesh Medical Device News Desk, January 21, 2019~ In a more than 2,000 word story on the mesh mesh, the Washington Post does an exhaustive story on eve…

DOCTOR DUH!

Sometimes I wonder if doctors read. I realize they spend a lot of time taking care of patients, often seeing one right after the other to keep a heal…

Coloplast Has Confirmed the Rumors that its Urology Division is for Sale