Surgical Mesh Crisis: Regulatory Action & Inaction

/Surgical Mesh Crisis: Regulatory Action & Inaction
Surgical Mesh Crisis: Regulatory Action & Inaction 2018-07-05T13:58:51+00:00

Hundreds of thousands of patients have suffered severe injuries after receiving surgical mesh products. But are policy makers tackling the issue? On this page, you’ll find stories on how regulatory officials and State lawmakers have attempted to address the mesh mess. You’ll also find critical pieces taking the FDA to task for its inaction.

Kentucky AG Files Deceptive Marketing Lawsuit Against Johnson & Johnson Over Surgical Mesh

andy beshear 2Mesh Medical Device News Desk, August 16, 2016 ~ Kentucky Joins Washington State and California in filing civil action against J&J for deceptively marketing its pelvic surgical mesh to consumers.  

Seeks millions in restitution. 

Kentucky is the latest state to file a civil lawsuit naming Johnson & Johnson and its medical device unit, Ethicon, for deceptively marketing surgical transvaginal mesh.

Kentuckys Seeks Millions In Civil Penalties

Disintegrating J&J mesh, Sling the Mesh campaign

Disintegrating J&J mesh, Sling the Mesh campaign, photo T Rogers

AG Andy Beshear’s office announced the lawsuit today. The state seeks millions of dollars in civil penalties from the healthcare giant.

The state alleges J&J violated Kentucky’s Consumer Protection Act that prohibits companies from introducing products into the marketplace using false, misleading deceptive or unfair acts.

“The way this company clearly chose profits over people is outrageous,” Beshear said. “My office has talked to victims whose lives have been devastated by this company’s deceitful practices. We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”

“I do not tolerate those who misrepresent their product by lying or lying by omission to Kentuckians.”   

It took a number of readers of Mesh News Desk to meet secretly with the AG’s office staff in Frankfurt to tell them their personal stories of life after a pelvic mesh product.

Women Say They Were Never Warned

They are just six of the more than 15,000 women implanted with J&J mesh in Kentucky who say they had insufficient information about the known hazards so they could make true informed consent, according to the lawsuit. Many have done so even though they were threatened by their law firms not to go forward or they would be dropped as clients.

The company ignored J&J insiders who wanted to add more risks to the warnings, says the action.

“The way this company clearly chose profits over people is outrageous,” Beshear said. “My office has talked to victims whose lives have been devastated by this company’s deceitful practices. We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”  

See the rest of AG Beshear’s press conference here.  See coverage on Stat here.

logoStat reports on the J&J response to the civil lawsuit.  According to an Ethicon spokeswoman the lawsuit is, “unjustified, and the company plans to vigorously defend itself against the allegations.  The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products.

“The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research … Ethicon is concerned that this lawsuit will keep women from obtaining treatment for the often debilitating symptoms of stress urinary incontinence.”

According to the AG’s lawsuit, the company intentionally and purposely concealed and misrepresented to doctors many of the risks and adverse events of the permanent implants which include chronic pain, infection, urinary and defecatory dysfunction, pain with sexual intercourse or loss of sexual function. Ethicon also called its pelvic mesh implants FDA approved, then it was only FDA cleared.

Similar Actions In California, Washington

Protesters at J&J shareholders meeting, April 2014

Protesters at J&J shareholders meeting, April 2014

The Attorneys General of both Washington State and California have also filed similar civil lawsuits alleging violations of their state’s Consumer Protection Act.

Johnson & Johnson/Ethicon has the greatest number of product liability lawsuits filed in the U.S. with 35,000 filed on the consolidated proceedings in West Virginia, and another 15,000 or so filed in individual state court.  Additionally, J&J is facing civil lawsuits in Australia, Israel, Canada, Scotland, among other countries.

Earlier this year, J&J lost two product liability lawsuits to plaintiffs in Philadelphia with a $12.5 million award to Patricia Hammons and $13.5 million jury verdict for Sharon Carlino.  See MND stories here and here.  

Women from Kentucky who are not represented in litigation but are asked to call the AG’s office at 502-696-5389.

The lawsuit was filed August 15, 2016 in Franklin Circuit Court, KY.

Here is the lawsuit:
http://ag.ky.gov/pdf_news/20160815_Complaint.pdf

AG Lawsuits Say J&J Deceptively Marketed Pelvic Mesh In Washington, California!

Washington State AG Bob Ferguson

Washington State AG Bob Ferguson

Mesh Medical Device News Desk, May 24, 2016 ~ She was
just one person who was mesh-injured.

“Susan” cannot be named because she is involved in litigation, but in 2012 she filed a complaint with her
home state of  Washington, specifically the State Attorney General’s Consumer Protection Division.

Susan told the office about her mesh injuries, about how there was no warning about the dangers of mesh, no informed consent and  about how thousands of women were also duped into believing a  “minimally invasive” procedure could cause a  lifetime of pain.

Washington Announces Major J&J Lawsuit

After years of investigation, today Washington State AG Bob Ferguson announced his office is filing a  lawsuit against Johnson & Johnson for deceiving the public and the state about the safety of its pelvic mesh implants, a violation of the state’s Consumer Protection Act (CPA).

The suit asks the court to prohibit Johnson & Johnson’s misleading marketing, find the company  violated the CPA, and impose the maximum $2,000 civil penalty per violation, in addition to costs,  fees and restitution.  See the press conference here.

The fines alone could reach tens of millions of dollars, and for the company, the revelations are something J&J tried to keep from the public.

Harris Says J&J Failed To Warn Patients, Public

Kamala Harris AG California

Kamala Harris AG California

The Washington State AG announced the action today as did the Attorney General for California Kamala Harris, also alleging deceptive trade practices and violations of consumer protections.

The allegations are New Jersey-based Johnson & Johnson and its Ethicon division failed to tell patients and doctors about the risks of pelvic mesh implants, made of polypropylene and used to shore up sagging organs or to treat incontinence. As a result, thousands of women were implanted who today suffer in some cases, irreversible complications including pain, repeated infections, nerve damage and an end to their sex lives.

“Difficult To Put Into Words”

“It’s difficult to put into words the horrific injuries and paibob ferguson ag washington staten many women are still suffering as a result of Johnson & Johnson’s deception,” Ferguson said. “They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials. This is an unacceptable way of doing business, and I will hold the company accountable.”

Washington State estimates 12,000 women there were implanted with J&J pelvic mesh. California believes there are 42,000 Ethicon mesh-implanted women there while J&J sold nearly 790,000 of its mesh implants from 2008 to 2014.

Other States Could Follow Suit

California and Washington led a group of 46 states and the District of Columbia in investigating the company’s practices. There is no word tonight whether other states also plan to file consumer protection violation lawsuits against J&J.

In a statement to Associated Press, J&J denies it did anything wrong and calls the lawsuits unjustified.

ethicon two“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” the company said. “The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.

“Ethicon is concerned that the Attorneys General’s decision to file its lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence.”

However, the mesh to treat stress urinary incontinence has already been found to be defective in several jury trials around the country and is falling out of favor with some doctors.

120,000+ Lawsuits Nationwide

There are in excess of 120,000 defective product lawsuits naming pelvic mesh made by seven manufacturers, filed by injured women in courts around the U.S.prolift box

Johnson & Johnson is facing about 45,000 lawsuits, more than any other defendant. Additionally, the company is facing similar defective product actions filed overseas including Scotland, Canada, Israel, Australia, among other countries.

Mesh used to treat pelvic organ prolapse or POP, has been quietly removed from the market by J&J. The FDA announced this year it will require testing for safety and efficacy before POP mesh can be marketed. Mesh for SUI remains on the market and is still referred to as “The Gold Standard” by medical societies, many of which are led by doctors who have financial arrangements with mesh manufacturers.

J&J introduced the TVT (transvaginal tape) in the U.S. in 1998, followed by the TVT-O (obturator), TVT-Secur, TVT Exact, TVT Abbrevo, Prolift, Prolift M+, Prisima and Artisyn. None of the mesh underwent clinical trials but that did not stop the company from proclaiming it was safe and effective.

Susan tells MND, “Maybe it will inspire others to file complaints with their Attorney General’s Offices.  It took courage to make the call.  I did not want to discuss my vagina or my leaky bladder with anyone, let alone a strange man.   I was so angry when I discovered that the mesh could not be seen with MRI, x-ray or any other technology that my rage overtook my shame.  My rage gave me the courage to make the call to a Senior Assistant Attorney General.  He had not heard of mesh and he didn’t watch TV so was unaware of the mesh adds.   I gave him the lowdown.   He was about to retire so he did nothing with the information.  Lisa Erwin, Assistant Attorney General, replaced him.   Lisa Erwin and her Investigator, Mary Beth Haggerty-Shaw took the ball and ran with it. Now, once again, we have a courageous man of integrity (AG Robert Ferguson) who is stepping out to fight Goliath in the pharmaceutical industry.   I am crying tears of joy today. “   

Specific Allegations

The complaint can be found here.  Violations include:

  • The Washington AG complaint states several violations of the Consumer Protection Act including assurances of safety and effectiveness of defendants mesh products even though that had not been validated in clinical trials.
  • Compensating sales reps and doctors to contact hospitals and conduct presentations as well as direct to consumer marketing based on false assurances.
  • Mesh was misrepresented to consumers as “soft and pliable and “a new and revolutionary surgical procedure,” while the company failed to disclose that it could incite foreign body reactions, shrink, fold, create bacterial colonies resistant to antibiotics, degrade, erode and oxidize.
  • The company misrepresented the pelvic mesh for SUI and POP had been “FDA approved” which indicates some oversight. In reality, the FDA does not regulate most medical devices other than to require a predicate device been named that is the “substantial equivalent.”
  • The Defendant did not include the dangers of mesh in its instructions for use (IFU). The risk of dyspareunia (painful sex) was not included until 2015; the risk of infection was included in 2012.

Women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact investigator MaryBeth Haggerty Shaw at MarybethH@atg.wa.gov or contact our Consumer Resource Center at 1-800-551-4636. Complaints can be filed at atg.wa.gov/file-complaint.

This case is being handled by Senior Counsel Lisa Erwin, Assistant Attorneys General Andrea Alegrett and Leilani Fisher. The case has been filed in King County Superior Court.

Boston Scientific On Hot Seat Amid Chinese Mesh Allegations

marion scott 2 april 2016Mesh Medical Device News Desk, May 14, 2016 ~ It’s been a circuitous route.

The latest news that mesh maker Boston Scientific (BSC) used substandard polypropylene resin smuggled in from China to make its pelvic mesh, comes all the way from Scotland.

Award winning reporter, Marion Scott writes, It was always scandalous. Was it criminal? in the April 24 pages of Scotland’s Sunday Mail.

Scott reports, “The firm, who supplied Scottish hospitals with Obtryx, Pinnacle and Advantage implants, have confirmed that all mesh products they have made in the past three years contain the Chinese resin.”

Reporter Scott says the quote in the story was directly from the company.

Confirmed: BSC Made Mesh With Chinese Resin

While BSC stands by its mesh, this is the first confirmation from BSC that it made pelvic mesh implants with Chinese-sourced resin.

Meanwhile publicly Boston Scientific clings to its many mottos – “Nothing is more important than women’s health,” and “Excellence is inherent in everything we do.”

The Mostyns

The Mostyns

 

Mostyn Firm: Old Evidence, Fresh Eyes

By his own admission Steve Mostyn was late to the game of pelvic mesh litigation.  Focusing primarily on natural disasters and insurance companies reluctant to pay, Mostyn Law of Houston is headed by Steve and his wife Amber. Media coverage shows they’ve been successful and effective.

God knows what Action Required emailLate one night several days before Christmas 2015, Steve was reviewing some of the ten million pages of documents produced so far in pelvic mesh litigation.

“I came across an email titled ‘Re: Counterfeit material from a supplier you use – ACTION REQUIRED.”  [LINK] There was an email from another division engineer saying their supplier attempted to sell them counterfeit goods and said God only knows what’s in there.’ I was shocked by this email.”

He spent most of the night digging further and the story emerged.

Further inquiry showed Boston Scientific had smuggled some grade of polypropylene (PP) out of China with no paperwork, no oversight and certainly with no approval. What was in this product? God only knows was right.

Plastics recycling, Guangdong Province, China

Plastics recycling, Guangdong Province, China

 

 

Chinese Resin: The Latest Assault

What the Mostyn firm has uncovered has ignited a new controversy in this ongoing defective product litigation that threatens Boston Scientific and its $120 million a year pelvic mesh business.

Documents showed BSC turned to China as a supplier between June 2011 and the fall of 2012 after former supplier, Phillips Sumika refused to sell to BSC “at any price.”  Phillips knew it product was being used for implantable medical devices and wanted no part of it.  Fearful its PP resin supply would dry up, BSC bought enough Chinese resin, 34,000 pounds of unknown quality to make pelvic mesh implants into the year 2032.

Counterfeit Manufacturer Identified

The supplier, EMAI Plastics Raw Materials Inc., located in Guangzhou, Guangdong Province was a known supplier of counterfeit products. China, with little environmental and consumer products regulation, has sent toxic dog treats to the U.S. and fed melamine-tainted milk to its infants, both with fatal results.

Not surprisingly, some of the resin was discovered by the firm to contain high levels of selenium, a trace element toxic in high levels. What did this mean for women implanted with mesh made from raw resin allegedly transported loose amid the debris and droppings on the floor of a rail car?

Yimao Plastic Molding

Yimao Plastic Molding

 

Protesters, fed court Charleston WV

Protesters, fed court Charleston WV

Rico Action

Teresa Stevens, 46, a West Virginia native, was implanted with a Boston Scientific pelvic mesh, the Obtryx-Halo Urethral Sling System made of Marlex in October 2014, to treat incontinence. Soon afterward she began having complications – urinary tract infections, shooting pains in her abdomen and painful sex.

She grew despondent, not unlike many of the 55,000 other women who receive a BSC pelvic mesh every year.

But Teresa Stevens v. Boston Scientific Case no. 2:16-cv-00265, stands out from the 91,000 other defective product cases filed in multidistrict litigation in West Virginia.

In January, the Mostyn firm, along with the Bell Law firm of Charleston, WV, filed a federal racketeering class action lawsuit against Boston Scientific – the first RICO lawsuit filed in transvaginal mesh litigation. RICO alleges fraud and the Racketeering Influenced and Corruption Organization statute (RICO), has long been used to target organized crime such as the Hell’s Angels, the Gambino family and even pedophile priests.

Leading a class action of injured women, Stevens, alleges for the class that BSC engaged in a pattern of unlawful activities including fraud, intentional misrepresentation, and negligent misrepresentation, violations of WV trade or consumer practices, and unjust enrichment.  It seeks unspecified damages on behalf of the women who would have received a BSC pelvic mesh made since September 2012, the date after which Boston Scientific allegedly defrauded the women by using the fraudulently obtained polypropylene resin to make its mesh.

RICO lawsuits can level both civil sanctions and criminal penalties and jail time, not to mention threefold the damages if successful.bs logo


Citizen’s Position

Knowing the FDA has the ability to issue a recall, the Mostyn firm did what no other has – file the first Citizen’s Petition to seek an immediate Class I recall of the BSC products and to quarantine the Chinese resin so no future products would be made from it.

The U.S. Food and Drug Administration has the power to revoke or amend its Federal Food, Drug and Cosmetic Act which oversees the fast-tracking of pelvic mesh to market.

On March 30, 2016, the petition was filed on behalf of Ms. Stevens containing a 35-page narrative of Boston Scientific’s alleged misconduct in sourcing PP resin in China and asks the agency to seek out the source of the raw material. Judge Joseph Goodwin overseeing 21,000 cases against BSC, was asked to move to restrain BSC from marketing or selling the mesh.

Federal Judge Defers Case To FDA

But instead of taking action, Judge Goodwin deferred the case to the FDA under primary jurisdiction doctrine. Ultimately, he decided, the FDA was best equipped to determine the safety and efficacy of the Boston Scientific mesh implants.

Saying it wasn’t aware of any safety issues, the FDA made a lackluster announcement on April 1, agreeing to let Boston Scientific investigate the safety and effectiveness of the its own products,

while acknowledging BSC urogynecologic surgical mesh “may” contain counterfeit raw material.

Steve Mostyn on 60 Minutes

Steve Mostyn on 60 Minutes

Sort of like asking a drug dealer to determine if the cocaine he was caught selling was really cocaine,” says Mostyn.  “I believe we will find there is no consistency in the product at all. With that province, a garbage dump for all sorts of industrial plastics, the FDA is not acting on behalf of the public and is abrogating its duty to public health and safety by giving Boston Scientific a pass.”                                                                                                                           ~ Steve Mostyn

In an April letter to FDA commissioner Dr Robert Califf and Health and Human Services Secretary Sylvia Mathews Burwell, Amber Mostyn urged the FDA to step up its investigation into criminal conduct and not allow Boston Scientific to simply compare new mesh implants to old ones.

Does the FDA believe equivalence is a defense to trafficking of counterfeit raw material in violation of 18 U.S.C. § 2320 (Trademark Counterfeiting Act)?” she asked.  

Grand Jury Investigation

Advantage Fix mesh, BSC

Advantage Fix mesh, BSC

Largely due to the new revelations uncovered by the Mostyn firm, federal prosecutors have now impaneled a grand jury to launch a criminal investigation into charges of fraudulent activity by Boston Scientific Corp.

Criminal penalties for smuggling counterfeit material and endangering public health can range from 20 years in prison for serious bodily harm, to life in prison for death and a $15 million fine for a company.

The grand jury in Charleston, W.Va., has sent out multiple subpoenas in recent months, one of which was obtained by the Boston Globe (here).

The investigation will determine whether Boston Scientific engaged in deceptive trade practices by receiving the substandard materials which it fraudulently sold to health care providers and ultimately implanted in unsuspecting women like Teresa Stevens.

Boston Scientific, responding to an inquiry by the Globe, denied it uses counterfeit or adulterated materials in its medical devices.

“Boston Scientific has a robust quality system and dedication to patient safety. We stand behind out products, the materials used in those products and our commitment to women’s health,” said a spokesperson. BSC has not responded to an inquiry by Mesh News Desk.

Green Light To More Discovery

In the latest turn, on May 5th, in the court overseeing transvaginal mesh medical products cases in California, Judge William F. Highberger denied Boston Science’s motion to bring a halt to future discovery into the Chinese resin issue.

Additional depositions and discovery will be conducted of Boston Scientific’s current and former employees, people in the know.

In making the ruling Judge Highberger ruled, “If the product is equivalent chemically but counterfeit in terms of its actual producer source, that raises legitimate questions as to why a manufacturer of products intended for human implantation would resort to such ruses to obtain needed raw material.  Plaintiffs so far “have made a sufficient showing that it has a reasonable potential for relevance, at least as to the issue of punitive damages.”

Steve Mostyn says in many ways the story of the entire mesh mishap is just beginning to be told. They’ve identified 10 prior manufacturers from 2003 to 2010 who refused to sell PP for use in implants. Why did those manufacturers shy away from the transvaginal mesh business? Mostyn’s instincts are still kicking in.

Steve Mostyn, Mostyn Law

Steve Mostyn, Mostyn Law

“The reality is you must have this fundamental information before you can evaluate the cases. We have found many things that do not relate to China but are highly relevant and we are now on a systematic review of all ten million pages and have requested additional documentation to fill in the holes.”

I believe we will find chemists within the company said you can’t put this stuff in the body,” he says.

The implications for all manufacturers in the mesh mess are huge.

“It was a straight up experiment.” Mostyn says. “That’s the core of it. I think synthetic polypropylene meshes for vaginal use should be off the market. Period.”

On Monday, April 16 Figueroa v. Boston Scientific will begin in a Dallas court before Judge Ken Molberg. Ms Figueroa was implanted with a Boston Scientific Solyx SIS mesh for incontinence in June 4, 2011, the same month the company allegedly began sourcing its pelvic mesh resin from China.

**UPDATE**  As of Friday, May 13, 2016, the Figueroa v. Boston Scientific trial has been rescheduled (again) to September 12, 2016. #

AGs In 50 States – Investigate J&J For Mesh Injuries, Costs, Document Destruction

canMesh Medical Device News Desk, May 28, 2014 ~ Today Corporate Action Network launched what is planned to be the first of a 50 state campaign to urge the Attorneys General of all 50 states to investigate healthcare giant Johnson & Johnson for mesh-injuries and their related costs and the destruction of documents requested in litigation.

There are presently at least 22,000 product liability lawsuits filed against J&J. Earlier this year a judge ruled the company destroyed hundreds if not thousands of pages of documents requested as part of the discovery process.

The first letters were sent to the Attorney General of California Kamala Harris and signed by ten women harmed by transvaginal mesh used to treat pelvic organ prolapse and stress urinary incontinence.  The other signed letter was sent to AG of New York Eric Schneiderman.

estelle tasz

J&J Headquarters, New Brunswick, NJ April 24, 2014

The request asks the company be held accountable for the document destruction including criminal penalties and names J&J CEO Alex Gorsky.  The documents destroyed were under a litigation hold and should have been presented to plaintiffs’ attorneys upon request.

The AG offices have the responsibility to seek reimbursement for the costs associated with a drug or medical device that was fraudulently marketed.  The editor of Mesh News Desk, Jane Akre, is involved in this campaign as a spokesperson.

Pelvic mesh survivors in other states plan to make similar requests to other state Attorneys General in the weeks and months ahead.

See the releases here:

New York

Here

California

Here

Hernia Mesh Complications – Is The FDA Watching? Part I

Removed hernia mesh plug, Dr. Kevin Peterson

Mesh Medical Device News Desk, November 28, 2012 ~ The U.S. Food and Drug Administration (FDA) has been updating pages on mesh used for hernia repair.

Unlike transvaginal mesh, also made of plastic polypropylene, there is no Health Notification or Safety Warning on hernia mesh. That means there are no active lawsuits involving hernia mesh, but injuries are coming into the agency nonetheless.

FDA Notifies Public Of Hernia Mesh Complications

For example in its updated November 20, page, the FDA reports it has received reports of complications associated with hernia mesh such as:

  • Adverse reactions to the mesh
  • Adhesions (when loops of the intestines adhere to the mesh or each other)
  • Injuries to nearby organs, nerves or blood vessels
  • Additional complications with or without mesh can include infection, chronic pain and hernia recurrence.

“Since the 1990s, there has been an increase in mesh-based hernia repairs – by 2000 non-mesh repairs represented less than 10 percent of groin hernia repair techniques.”

That may explain why, at least anecdotally, there appears to be an increase in hernia mesh complications. MDND receives calls frequently from patients who have a diminished quality of life after a surgical mesh implant for hernia repair.   See Kristina Graham’s story in Part II (here).

This woman, who is represented by a lawyer and can’t be identified, wrote MDND to say both she and her husband  have Atrium CQUR hernia mesh, which is a polypropylene mesh coated with “Omega 3  Bioabsorbably Oil Fatty Acid (03FA). See product here.

“Its been 11 months and my husband is still suffering. One implant, one removal, one more implant and a massive infection which nearly took his life. now needs a third very difficult surgery to remove the second implant. Loss of over 96,000 a year income form our business, loss of life as he knew it, constant pain. Its not a pretty picture.”

Complications can include pain, nerve entrapment, reduced movement, and a foreign object reaction that can include fever, swelling, and general malaise.

Hernia mesh, WikiCommons

Synthetic Hernia Mesh

 

Mesh is either synthetic – a knitted material or non-knitted sheet. It may be absorbable, or non-absorbable or a combination of both. Non-absorbable mesh, which is mostly synthetic, will stay in the body indefinitely. It is a permanent implant and difficult to remove.

Animal-Derived Hernia Mesh

 

Animal-derived mesh can be made from animal tissue, such as the intestine or skin of a pig (porcine) or cow (bovine) that is processed and sterilized. Animal-derived mesh is absorbable.

Over time, absorbable mesh will degrade and lose strength while new tissue growth takes over to strengthen the repair.

With or Without Mesh  – Hernia Repair Complications include:

  • Pain
  • Infection
  • Hernia recurrence
  • Tissues that stick together (adhesion)
  • Blockage of large or small intestine (obstruction)
  • Bleeding
  • Abnormal connection between organs, vessels, or intestines (fistulas)
  • Fluid build-up at the surgical site (seroma) and perforation or a hold in neighboring organs or tissues

WITH Mesh:

The FDA says it has received reports of:

  • Pain
  • Infection
  • Recurrence
  • Adhesion
  • Obstruction
  • Perforation which can lead to sepsis or poisoning of the blood stream and is potentially fatal

Recalled Hernia Mesh

The FDA update says “Most of the complications reported to us so far have been associated with mesh products that have been recalled and are no longer on the market.

This is perplexing because besides the largest hernia mesh recall for Kugel mesh, there have been very few recalls of hernia mesh with the exception of a few manufacturing lots recalled over mislabeling and/or sterility issues.

More than 2,000 lawsuits were filed against C.R. Bard, maker of the Composix Kugel Mesh hernia patch which was recalled three times between 2005 and 2007 because the memory ring broke and could cause serious perforations. The company redesigned the Kugel patch and reintroduced it in the market through the 510(k) approval process. The FDA Kugel mesh recall December 2004 is here.  The 2005 Kugel mesh recall is here.

Besides Kugel, the Proceed surgical mesh had Ethicon recall 18,270 lots in January 2006 when the polypropylene delaminated from the mesh, opening up the patient to the possibility of fissures and adhesions.

The FDA report is here.

The only other large hernia mesh recall was in September 2005 by LifeCell Corporation over its AlloDerm mesh. It was determined that about one-quarter of those implanted with the donated human/cadaver skin mesh had complications including infection and rejection.

The remainder of mesh recalls have been limited to small numbers of mesh due to sterility or mislabels.

Hernia Mesh Complications: Is The FDA Watching? Part II

Dr. Kevin Petersen, YouTube, No Insurance Surgery

November 28, 2012 ~ According to hernia mesh removal surgeon, Dr. Kevin Petersen, in a certain percentage of patients, the body will detect hernia mesh as a foreign material and will reject it.

Symptoms may include scar tissue that leads to chronic pain and causes mesh to shrink and shrivel up, pulls on its anchors which can detach and dislodge and free itself from the hernia.

Dr. Petersen has been removing mesh at his No Insurance Surgery Center in Las Vegas. He does not use mesh. He says in a YouTube video he’s probably done 5,000 hernia procedures and has been a surgeon for 25 years.

Dr. Petersen claims non-mesh repair has a recurrence rate of less than 3 percent.

Kristina Graham

Kristina Graham and family

Kristina Graham will be visiting Dr. Petersen for a mesh removal at the end of December.

The 34-year-old hairdresser from Carey, North Carolina was in a car accident and the seat belt caused  trauma to her abdomen. The doctor treated it like an inguinal hernia and implanted Ethicon Prolene Hernia mesh.

Graham had pain right away and was told it was nerve damage. Another doctor surgically removed nerves but put in more mesh. Since February 2012, Graham says she’s been walking around like she was shot in the abdomen.

She was told to suck it up and go back to her hardcore workouts – weights and running. She was sent on the round robin of doctors and to a physical therapist for pelvic floor massage. The gynecologist said she had cysts.

Graham is slim and healthy, eats organic food and drinks plenty of water but the swelling has spread from the incision to her hip and public bone.

“I did everything I was told and finally they said get pain meds and just get comfortable. I’m 34-years-old and have a 2 and 4-year-old. That’s not the life I want,” she says today. “Nobody wanted anything to do with it, they said removal wasn’t possible.”

Graham’s insurance company checked with nearby hernia surgeons and the consensus was no one wanted to clean up someone else’s mess. That is how Graham got the referral to Dr. Petersen for the out-of-state removal surgery.

Graham says she was not told about the potential for complications prior to mesh surgery.

“If I had known the reality I would have different things to say. Doctors don’t want you to know.”

Graham wants people to be proactive when it comes to their own health. She has spent time finding procedure codes to get her insurance, Blue Cross Blue Shield, to pay her back for the procedure with Dr. Petersen.

“This surgery has to happen through their network providers and if they can’t do it, they will pay for going out of network. I pay the doctor and they pay me back. They talk to 100 providers on the list and when 100 won’t do it, they let you go out of state. That’s the law. That’s another thing people need to know.”

Graham has her medical records and with that information plans to file a complaint with the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database).  It is the only way for the agency to track the real injuries occurring among patients treated with an FDA approved medical device. Follow the MDND procedure on doing that here.

Search the MAUDE database to pull up reports done by others injured by the same medical device as yours. For example,  this is an adverse event reported August 24, 2011 concerning an Ethicon Prolene Mesh Hernia system implanted July 14, 2004, as seen here:

“I had hernia surgery in (b)(6) 2004 and they put Ethicon prolene mesh in me. I was fine until (b)(6). Now i have severe pain where the surgery was done and all the way down into my penis. I am sick to my stomach and hurt like a stabbing feeling and needles sticking me. Everything i read says it is the mesh but now i have no insurance and i am trying to hold on as long as possible but it is getting really hard to handle the pain much longer. I got my medical records from the surgery but i really don’t know how to tell what mesh is recalled. I just know mine is hurting.”

Ethicon, a division of Johnson & Johnson, produces the Prolene Hernia System. Prolene is the company’s trademark name for polypropylene mesh.  Other brands of hernia mesh from Ethicon include Proceed Mesh, Prolene 3D Patch Mesh, among others. The Ethicon Prolene Hernia System and Bard 3D Max Mesh are products commonly used to repair hernias. See their brochure here.

Learn More:

Here is a Topix page on hernia mesh

http://www.topix.com/forum/health/TE4DF83JKBNACOFNO/p226

Dr. Kevin Petersen on Non-Mesh Surgery (video) Open non-mesh repair

http://www.youtube.com/watch?v=LopM7hLFV_s

Hernia brochure American College of Surgeons

http://www.facs.org/public_info/operation/brochures/hernrep.pdf

Here is how to search for a complication by putting the name of the mesh in the search box.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/textsearch.cfm