Uterine Fibroid Embolization Safer and Cheaper than Morcellation But Underused

By Emily Cox
Uterine Fibroid
Photo by Tom Blunt

Washington, D.C. – As safety concerns continue to mount over the risks associated with morcellation, new research indicates that less invasive embolization is vastly underutilized for uterine fibroid removal even though it’s safer and less expensive.

The study’s lead author presented the research at the Society of Interventional Radiology’s annual meeting in Washington, D.C., earlier this month. Researchers found that the medical community vastly underuses a technique called uterine fibroid embolization, favoring more invasive and expensive laparoscopic hysterectomies that may involve the use of a power morcellator.

Power Morcellators Vs. Uterine Fibroid Embolization

Power morcellators are medical devices for minimally invasive hysterectomies. Surgeons use them to cut up and remove the uterus and uterine fibroids through a small abdominal incision. While they were exceedingly popular during the past decade, most doctors will not use the devices anymore as morcellators can spread undiagnosed uterine cancer cells. Consequently, this rapidly upstages aggressive cancers and shortens life-expectancy.

In comparison, embolization doesn’t require a surgical incision. Instead radiologist inserts a catheter into the artery at the groin or wrist. The doctor then guides the catheter to the fibroid’s blood supply where tiny particles are released to block the small blood vessels. This deprives the fibroid of nutrients, resulting in fibroid softening and shrinking, as well as less bleeding. Researchers estimate that nine out of 10 patients who undergo uterine fibroid embolization experience significant improvement or complete resolution of their symptoms.

Uterine Fibroids

Uterine fibroids are growths made of smooth muscle cells and other tissue that develop within the wall of the uterus.

According to the National Institute of Child Health and Human Development, the majority of women develop uterine fibroids. One study found that between 80% and 90% of African American women and 70% of white women develop fibroids by age 50. Research shows that 90% of these women will seek medical or surgical treatment within one year of diagnosis. While fibroids usually grow in women of childbearing age, women undergo hysterectomies most of the time. This new research indicates that women are not fully aware of their treatment options. It further suggests that these women would chose preserve their uterus and ability to bear children if given this choice.

Women Not Aware of Uterine Fibroid Embolization Benefits

Embolization allows women to keep their uterus and removes the risk of cancer upstaging. However, the study found there were more than 65 times as many hysterectomies performed for uterine fibroids than embolization. In 2013, there were approximately 78,200 hysterectomies for fibroids in 2013. While this is down from 168,000 in 2007, there were less than 2,500 embolization procedures during this time.

“These findings suggest there is a lack of awareness about this safe, effective and less invasive therapy for uterine fibroids,” said Prasoon Mohan, the study’s lead author. “Patients need to know about the major differences between surgical treatments and [uterine fibroid embolization], especially that this is a non-surgical treatment that preserves the uterus and has a much faster recovery time compared to hysterectomy.”

The data also showed the uterine fibroid embolization resulted in shorter hospital stays. Furthermore, it was less expensive than hysterectomy by about $12,000. Researchers are urging the medical community to educate patients about their choices and determine ways to increase access to this effective, less invasive treatment.

Power Morcellator Lawsuits

Lawmakers, consumer advocates, and families of cancer victims have pressured the FDA to recall power morcellators. Unfortunately, the FDA has decided not to recall power morcellators at this time. However, they did require manufacturers to add a prominent “black box warning” to device labels in April 2014. These labels clearly state that the devices may spread undetected cancer and decrease long-term survival. Since the FDA issued these warnings, Johnson & Johnson has faced dozens of morcellator cancer lawsuits. These women allege these devices are defective and dangerous and that the company failed to warn the medical community.

Johnson & Johnson’s Ethicon unit was previously the main manufacturer of morcellators. It has since stopped selling the medical device. But other companies continue to manufacturer and sell these controversial tools.

Mesothelioma Deaths Exceeded 45,000 During 15 Year Period

By Emily Cox
Mesothelioma Deaths
Photo by Martin Hesketh

A new government report shows more than 45,000 malignant mesothelioma deaths from 1999 to 2015 with annual lives lost continuing to increase, especially among older Americans who came into contact with asbestos decades earlier.

The March 3 issue of the U.S. Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) indicates that the number of mesothelioma deaths continue to increase. However, prior projections suggested that the impact of asbestos should have peaked by now. Instead it increased 4.8 percent from 1999 to 2015.

“After 2005, mortality was projected to decrease,” the report stated. “Despite regulatory actions and the decline in use of asbestos, the annual number of malignant mesothelioma deaths remains substantial.”

These findings suggest that asbestos exposure is continuing at unacceptable rates. According to their research, 20 percent of construction industry air samples from 2003 exceeded the asbestos exposure limits. The CDC also found that many asbestos products remain in use with new asbestos products manufacturing continuing in the U.S.

The only known cause of the mesothelioma is asbestos exposure. The manufacturing and building industry used asbestos extensively until regulatory agencies banned most uses more than three decades ago. However, the time from exposure to developing malignant mesothelioma can be as long as 71 years.

Since it is usually not diagnosed until it’s in a very advanced stage, mesothelioma is almost always fatal. Consequently, there is a very short life-expectancy after diagnosis as well. Researchers found that patients have a median survival of approximately one year from the time of diagnosis.

Mesothelioma Deaths Litigation

Mesothelioma Deaths Caused by Asbestos
Photo by Aaron Suggs

More than 600,000 people have filed lawsuits against more than 6,000 defendants due to injuries caused by breathing asbestos fibers. This makes it the largest mass-tort in U.S. history. Besides people directly exposed to the toxic substance, a growing number of lawsuits involve second-hand exposure by individuals who inhaled asbestos from the hair or clothes of their parents during childhood.

 

Poisoned Camp Lejeune Veterans to Receive Compensation

By Emily Cox
Camp Lejeune Contaminated Water
Photo by Public Domain Photography

Veterans who served at Camp Lejeune in North Carolina from the 1950s through the 1980s may be eligible to receive compensation payments if they suffered from certain cancers or other select diseases.

The federal Veterans Administration has acknowledged that the water at the camp probably caused many forms of cancer found in veterans who served at Camp Lejeune for 30 days or more. The contamination occurred between August 1, 1953 and December 31, 1987. Consequently, these veterans showered, drank, and ate food cooked in a poisonous stew of benzene, perchloroethylene, trichloroethylene, and vinyl chloride among other harmful chemicals that may cause breast cancer, adult leukemia, bladder cancer, non-Hodgkin’s lymphoma and Parkinson’s disease. Authorities think the water was contaminated by a nearby dry cleaning business leaking chemicals into the ground water.

Camp Lejeune Veteran Compensation

The U.S. government freed up about $2.2 billion Tuesday to compensate veterans who are struggling with at least one of the eight diseases linked to the toxic water they were exposed to while serving their country.  However, several family members of veterans and civilians said they hope the compensation will grow to include more diseases as well as civilian employees who may have been exposed.

This will be the first time that the government will compensate veterans for harm done at home rather than foreign soil during wartime. Also, there is no requirement to prove a direct link between the water and any of the identified illnesses.

While there are nearly a million people eligible for this compensation, the government isn’t reaching out to them. Consequently, they are responsible for filing their own claims. But many veterans aren’t even aware of the water contamination or the health impacts.

Camp Lejeune Veteran Health Benefits

Per the 2012 Camp Lejeune health care law, the VA also provides free health care for certain conditions for vets who served at least 30 days of active duty at Camp Lejeune from January 1, 1957 and December 31, 1987. Qualifying conditions for free health care include:

  • Esophageal cancer
  • Breast cancer

    Camp Lejeune Vets
    Photo by AK Rockefeller
  • Kidney cancer
  • Multiple myeloma
  • Renal toxicity
  • Female infertility
  • Scleroderma
  • Non-Hodgkin’s lymphoma
  • Bladder cancer
  • Lung cancer
  • Leukemia
  • Myelodyspastic syndromes
  • Hepatic steatosis
  • Miscarriage
  • Neurobehavioral effects

Eliquis Bleeding Permanently Damages Man

By Emily Cox
Eliquis Bleeding
Photo by gurmit singh

A recent product liability lawsuit against the anticoagulant manufacturers alleges that Eliquis bleeding permanently damaged a New York man.

David Reed filed the complaint in Delaware Superior Court on February 27. He claims that Bristol-Myers Squibb and Pfizer misrepresented Eliquis as safe and effective, while concealing the significant uncontrollable bleeding risks.

According to the complaint, Reed began taking Eliquis on January 8, 2015, after vascular surgery. He was hospitalized for bleeding complications by January 26, 2015. He was hospitalized again March 30, 2015, due to gastrointestinal bleeding. Reed claims he has suffered severe pain and permanent damages that could have been avoided if the companies had provided adequate warnings and information about the risk of Eliquis bleeding.

“Had Plaintiff known the true facts with respect to the dangerous and serious health and safety concerns of Eliquis, Plaintiff would not have purchased, used, and relied on Defendant’s drug Eliquis,” the claim states.

According to the lawsuit, the drug makers concealed their knowledge of Eliquis’ defects, defrauding and deceiving the public, FDA, and medical community.

Eliquis received FDA approval in 2012. The lawsuit alleges that the ARTISTOTLE clinical trials were a determining factor for Eliquis’ approval. However, it further claims that the drug makers chose “incompetent and untrustworthy” agents in China to conduct the study to cut costs. Allegedly, the companies concealed side effects in test users, including Eliquis bleeding and a death. There are also allegations of major dispensing errors where subjects were not even receiving Eliquis, poor quality control, and record destruction, as well as changing and falsifying records. In a February 2012 meeting with the FDA and company executives, the FDA characterized the companies as showing a pattern of inadequate supervision.

Eliquis Bleeding Risks

Eliquis is part of a new group of oral anticoagulants, known as factor xa medications. This group also includes Xarelto and Pradaxa.

While manufacturers aggressively marketed these drugs as a replacement for Coumadin (warfarin), manufacturers released them without antidotes for bleeding incidents. Whereas vitamin K can reverse Coumadin’s anticoagulant effects. Consequently, a large number of individuals have reported Eliquis bleeding problems.

“Before and after marketing Eliquis, Defendants became aware of many reports of serious hemorrhaging in users of its drug,” the complaint states.

The claim asserts that the side effect data generated obvious signals that Eliquis bleeding was a serious concern. However, manufacturers never alerted the public and scientific community. They also never performed further investigation into Eliquis’ safety.

In February, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all Eliquis proceedings in the Southern District of New York.

Pradaxa and Xarelto Lawsuits

The JPML has centralized litigation for Xarelto and Pradaxa as well. Pradaxa maker Boehringer Ingelheim agreed to pay $650 million in 2014 to resolve about 4,000 cases. Xarelto has more than 15,000 lawsuits pending in its centralized litigation over uncontrollable bleeding.

Ethicon Hernia Mesh Case Centralization Requested

3/21 Update – This article was updated to reflect that Ethicon Physiomesh was not recalled. It was a voluntary market withdrawal.

By Emily Cox
Ethicon Hernia Mesh Case Centralization
Photo by Tim Green

A group of plaintiffs are requesting Ethicon hernia mesh case centralization due to the increasing number of cases, alleging that Physiomesh caused serious complications and additional surgery.

The plaintiffs filed the motion to transfer with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on March 9. They are requesting that the JPML transfer all lawsuits involving the Ethicon hernia mesh to the Middle District of Florida. The centralized proceedings will help avoid duplicate discovery and conflicting rulings, saving time and money for all parties.

According to the motion, there are at least 18 product liability lawsuits pending in nine separate federal courts. These individuals claim that the Ethicon hernia mesh caused severe harm that often required additional invasive surgery. Furthermore, in some cases, this harm is irreparable. The motion also noted that six of the cases were already in the Middle District of Florida. This is the most of any one district.

Ethicon Hernia Mesh Design Defect

Ethicon Physiomesh is a hernia mesh patch Ethicon released in March 2010. Up until its May 2016 market withdrawal, surgeons widely used this product to repair hernias. The hernia mesh allegedly caused severe complications, including adhesions, mesh erosion, perforation, and infections. Many of these conditions require additional invasive surgery to treat.

The motion alleges that this voluntary market withdrawal was a direct consequence of the frequency and severity of the complications experienced with the hernia mesh worldwide.

Plaintiffs claim that the hernia mesh’s design caused many of the complications. Ethicon Physiomesh has five distinct layers with a multi-layer coating. No other hernia repair product in the world uses this design.

Plaintiffs allege Johnson & Johnson and its Ethicon subsidiary promoted the coating to prevent or minimize adhesion and inflammation while helping the mesh incorporate into the abdomen.

“However, Plaintiffs intend to demonstrate that the multi-layer coating instead prevented adequate incorporation of the mesh and caused or contributed to a variety of serious complications,” the motion went on to state.

It also seems to have caused severe inflammatory and foreign body responses. In turn, these responses cause scar tissue that starts to connect organs, which is a severe complication that requires surgery.

Given the popularity of the Ethicon hernia mesh with surgeons before its market withdrawal, experts expect the size of this litigation to grow dramatically.

Cook IVC Filter Settlement Conferences Scheduled

By Emily Cox
Cook IVC Filter Justice
Photo by Bri

A judge has ordered a series of three Cook IVC filter settlement conferences to try to resolve lawsuits against Cook Medical before the first bellwether trials begin later this year.

U.S. Magistrate Judge Tim A. Baker issued the order March 7. He scheduled the first conference for the plaintiffs’ counsel July 26. There will be subsequent conferences for the defendant’s council August 4 with a follow-up for the plaintiff’s August 9.

The conferences will propose Cook IVC filter settlement frameworks that may eliminate the need for additional trials later this year. There will also be confidential discussions on case status, discovery, and trial preparation. Judge Baker will make assessments of the relative strengths and weaknesses of both sides of the litigation.

While previous Cook IVC filter settlement conferences have convened, parties have not been able to reach an agreement.

Cook IVC Filter Complications

Cook designed and sold IVC filters to prevent blood clots from travelling to the heart and lungs. However, these lawsuits allege that these filters caused various serious complications. A 2012 study, published in CardioVascular and Interventional Radiology medical journal, indicated that all Cook Celect and Gunther Tulip filters showed some degree of IVC perforation. Researchers found that full perforation occurred in 86 percent of the cases, while 40 percent of filters tilted out of position. Furthermore, while these filters are temporary, doctors rarely remove them. When the filters are left in for extended periods of time, they can break. This can allow pieces of the filter to get lodged in other parts of the body, usually the heart or lungs.

In May 2014, the FDA issued a safety communication regarding IVC filters. The agency released the report due to excessive reports of IVC filters breaking and damaging the heart, lungs, and other organs.

There are currently about 1,500 cases against Cook IVC filters with plaintiffs alleging these and other problems. Bard IVC filters have similar complications, along with associated litigations pending against them.

Class Action Restriction Bills Passed by House

By Emily Cox
Class Action
Photo by Joey Gannon

Washington, DC — Despite Democratic objections that class action restrictions would hurt the public’s ability to hold corporations accountable, the House of Representatives passed a pair of bills Thursday to make it harder to bring class actions and keep suits in state courts.

The Fairness in Class Action Litigation Act of 2017 and Innocent Party Protection Act radically limit the scope for class actions, while expanding the scope for finding fraudulent joinder in suits.

Republicans claim these bills will adjust the balance between “abusive plaintiffs” and “innocent defendants.” However, Democrats argue the bills are designed to protect corporate wrongdoers by making it harder for victims to band together. Democrats allege that these bills would make it almost impossible for victims injured by consumer rip-off, fault product design, and pharmaceutical drug mistakes, as well as lead and asbestos poisoning to bring class-action lawsuits.

“I oppose these misguided legislations, because it sends another huge valentine and wet kiss to large corporate polluters and tort-feasors but gives the finger to millions of American citizens who suffer injuries from these defendants,” Rep. Jamie Raskin (D-Md) said.

Democrats are joined by a large group of legal, environmental, disability, labor, civil rights, and consumer protection organizations in their opposition. They claim the bills would limit the ability to join a class action suit against defendants with exponentially greater resources.

“Christmas has certainly come early for corporate-America,” said Teddy Basham-Witherington, a spokesman for The Impact Fund, a nonprofit public interest law organization.

He went on to that, if passed, the class action restriction bills would “restrict ordinary people from accessing justice, emboldening the worst actors in corporate America.”

Class Action Restriction Bill (H.R. 985)

The class action bill would require plaintiffs to prove potential members have the same type and scope of injury. It also requires asbestos trusts to make details of trust claimants public.

“This doesn’t formally abolish the class-action mechanism,” Rep. Jamie Raskin (D-MD) said. “It’s not the guillotine, but it’s a straight jacket.”

Opponents also argue that the bill provides easy access to asbestos victims’ personal information for scam artists, employers, potential insurers, and debt collectors to potentially exploit.

The bill’s predecessor, the Fairness in Class Action Litigation Act of 2015 (H.R. 1927), passed the House but was not even considered by the Senate. According to opponents, this bill was far less damaging than the current legislation. Basham-Witherington described the new bill as “H.R. 1927 on steroids.”

Innocent Party Protection Act

This bill would prevent attorneys from adding defendants to a lawsuit to keep the case in state court. Democrats like Jerrold Nadler (NY) feel that it gives corporations another tool to transfer suits to corporate-friendly federal courts.

“The preliminary determination of jurisdiction would become a baseless time-consuming mini-trial before a second trial on the merits,” Nadler said. “While large corporations can accommodate such costs, injured workers, and parents cannot.”

Take Justice Back

The American Association for Justice has established a movement to help individuals take a stand against class action restriction. Take Justice Back has numerous websites to help people act against this unconstitutional legislation.

 

Judge Approves $12M Caldera Pelvic Mesh Deal Despite Protests

By Emily CoxCaldera Pelvic Mesh Deal

Despite 36 objectors, a California federal judge approved Federal Insurance Company’s $12.25 million deal to resolve insurance claims, alleging that Caldera pelvic mesh implant injured more than 2,700 women.

Federal Insurance agreed to distribute $10.58 million among the 2,710 claimants and to pay $670,020 in attorney fees and costs. In return, the plaintiffs agreed to release Caldera and Federal Insurance from all future claims.

In his order, issued March 6, U.S. Judge Stephen V. Wilson pronounced the deal as fair, reasonable, adequate, and “consistent with due process.”

Caldera Pelvic Mesh Federal Interpleader Suit

Federal Insurance first launched its federal interpleader suit against Caldera and a class of claimants in January 2015 after Caldera started filing insurance claims to pay for damages awarded to plaintiffs over the pelvic mesh product designed to treat pelvic organ prolapse and stress urinary incontinence in women.

The plaintiffs claimed that Caldera knew or should have known that its transvaginal mesh devices were hazardous and dangerous. Consequently, they sought damages from Caldera, which turned around to file insurance claims to pay for these settlements.

According to Federal Insurance’s complaint, Caldera was depleting its $25 million policy by fighting these lawsuits in state court. The complaint also noted that it had already paid out more than $6.3 million in settlements with thousands more claims still pending. Federal Insurance requested the court to identify a class of claimants and stop them from pursuing future suits that would affect the insurance policy.

Caldera Pelvic Mesh Deal

In December 2015, the parties reached a $12.25 million lump sum deal with a $500,000 holdout to resolve pending claims and end its policy with Caldera. The deal stipulated that claimants could not opt out of the settlement.

But, three dozen women objected in June 2016. They wanted evidence that showed if the payout would be greater if Caldera liquidated. They requested an independent audit to make sure Caldera was offering the maximum amount possible to women injured by the pelvic mesh device.

Caldera and Federal Insurance argued an audit wasn’t necessary as Caldera had already produced financial records. The records indicated that the company was cash-poor, had no profit, and only had its insurance to settle the lawsuits. Furthermore, there was nothing that showed the liquidated value of the company would exceed the current settlement.

In July, Judge Wilson sided with the objectors and ordered Caldera to submit supportive evidence.

In September, Caldera filed an expert report. It showed any attempt to liquidate Caldera would result in a net loss. The company also filed another motion for final settlement approval. However, objectors challenged the deal and the export reports findings. At least, one objector requested exclusion from the deal.

However, Judge Wilson refused to excuse the objectors from the settlement. He found that the report sufficiently addressed concerns and approved this past Friday.

The deal is a victory, according to plaintiff attorneys. They said that since Caldera’s only real asset is its insurance policy, this was the only way that the claimants were going to get anything.

Transvaginal Mesh Lawsuits

In 2011, the FDA issued a warning after receiving almost 2,900 reports of problems with vaginal mesh products between January 2008 and December 2010. The FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared totraditional treatments.

In early 2012, the FDA sent a letter to several pelvic mesh manufacturers. The letter ordered that they conduct additional studies and trials to evaluate these products’ safety, and establish whether they pose an unreasonable risk of injury for women.

However, many of the manufacturers did not follow-through with the safety studies. Instead, they removed the products from the market.

Tens of thousands of women have filed pelvic mesh lawsuits against about half a dozen manufacturers. Thousands of cases have been settled out of court, and a number of cases have resulted in multi-million dollar jury verdicts for women who suffered permanent and debilitating injuries.

Stryker Metal Hip Corrosion Linked to Design

By Emily Cox

Stryker Metal HipA new product liability lawsuit claims that the design of Accolade and LFitV40 components caused a  Stryker metal hip to corrode and fail, resulting in metal blood poisoning and additional invasive surgery.

The lawsuit was filed by David Campbell on March 3. He indicates that Howmedica Osteonics Corp, doing business as Stryker Orthopaedics, sold defective hip components that were likely to corrode and fail.

In April 2010, Campbell had a Stryker Accolade TMZF Hip Stem and Stryker LFit Anatomic V40 femoral head implanted. The artificial hip failed within a few years due to wear and corrosion where the cobalt and chromium femoral head rubbed against the metal hip stem.

Stryker metal hip corrosion can cause loss of mobility, soft tissue damage, and severe pain and discomfort, as well as heavy metal poisoning. Per the claim, Campbell experienced all of these side effects, and some of the damage may be permanent. Consequently, he required hip revision surgery in March 2015 to remove the faulty components.

The lawsuit suggests that revision surgeries are more invasive and complex than original hip replacement surgeries. They also take longer than the original surgeries and have a higher rate of complications.

Campbell alleges that he will require years of additional medical treatment. This may include potential additional revision surgeries due to Stryker metal hip corrosion.

In August 2016, Stryker issued a Stryker LFitv40 hip recall. At this time, Stryker admitted to a high number of individuals reporting problems with hip failure, metal wear, adverse tissue reactions, metal poisoning, and other complications.

Stryker Metal Hip Lawsuits

Campbell joins the growing ranks of individuals filing similar Stryker hip lawsuits due to problems of the metal-on-metal implant.

Legal experts expect that thousands of individuals will file additional lawsuits as Stryker metal hips continue to injure recipients. Hip replacement lawyers are also accepting cases for individuals who still have these components in their bodies. These materials could be releasing toxic levels of metal as their hip replacement corrodes unknown to them.

Ethicon Physiomesh Eroded into Man’s Intestines

By Emily Cox
Physiomesh Eroded Into Intestines
Photo by Jason Wilson

According to a new product liability lawsuit, an Ethicon Physiomesh eroded into a man’s intestines, causing severe injuries and complications.

The complaint was filed by Henry Lee Brown in the Northern District of Georgia in late February. Brown alleges that Johnson & Johnson’s and its Ethicon subsidiary’s Physiomesh is prone to erosion, adhesions, perforation, fitulas, bowel strangulation, and hernia incarceration among other problems.

The suit states that Brown had a 15cm x 20cm patch of Ethicon Physiomesh implanted in his abdomen for hernia repair. However, the patch failed and the Physiomesh eroded into his intestines. Mesh erosion is one of the most serious complications of hernia mesh products. It occurs when the mesh patch moves into surrounding organs. Brown required invasive surgery to remove the Physiomesh. Surgeons removed a portion of Brown’s small bowel to eliminate adhesions. Scar tissue unnaturally connecting organs causes these adhesions.

Physiomesh Eroded Due to Defective Design

No other hernia mesh patch on the market uses Physiomesh’s unique design. It has a total of five distinct layers. Ethicon designed the multi-layer coating to prevent adhesions and inflammation, while helping the mesh incorporate into the body. However, reports have linked it to a high rate of intense inflammatory and chronic foreign body responses, causing problems like Brown’s.

“The multi-layer coating provides a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate,” his lawsuit states. “The multi-layer coating of Defendants’ Physiomesh is cytotoxic, immunogenic, and not biocompatible, which causes or contributes to complications such as delayed wound healing, inflammation, foreign body response, rejection, infection and other complications.”

In May 2016, Ethicon issued a voluntary product recall of certain Physiomesh products. Ethicon classified this as a market withdrawal. However, the company said it would not return any of these devices to the market.

“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” the letter stated. “Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”

Brown’s lawsuit joins a growing number of similar lawsuits, asserting serious injuries from Ethicon’s Physiomesh. However, experts expect that the company may face thousands of cases in the future.

 

 

 

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