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Ethicon Media Monitoring 3/29/2019
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J&J Can't Get Pa. Mesh Mistrial Over Expert's Heart Attack
Mar 28, 2019 | Law 360
By Matt Fair
Philadelphia judge has refused to declare a mistrial in an ongoing pelvic mesh injury trial based on what a Johnson & Johnson unit said was its inability to call an expert witness recovering from a recent medical emergency. -
Law Firms Objecting to Mesh Fees Accuse Leadership of Self-Dealing, Bill-Padding
Mar 28, 2019 | Law.com
By Amanda Bronstad
Law firms objecting to their share of an estimated $550 million in attorney fees in the trans-vaginal mesh litigation have raised new accusations that lawyers tasked with allocating those funds resorted to self-dealing and bill-padding to line their own pockets. -
Almost 60 patients have been told by hospital they should not have been operated on
Mar 28, 2019 | The London Economic
By Ben Gelblum
Dozens of women who were given a controversial type of bowel mesh surgery should NOT have been operated on, a hospital trust has admitted. -
Nearly 60 patients including women 'left in severe pain' after pelvic floor operations should not have gone under suspended surgeon's knife, NHS admits
Mar 28, 2019 | Daily Mail
By Joel Adams
More than 50 patients who were given a controversial type of bowel surgery should not have been operated on, a hospital trust has admitted. -
Southmead patients told surgery was unnecessary
Mar 28, 2019 | Gazette Series
By Huw Mabe
Fifty-seven patients who received pelvic floor surgery at Southmead Hospital have been told it was unnecessary. -
FDA prepares for possible device shortages after gas leaks lead to closure of sterilization plant
Mar 27, 2019 | Fierce BioTech
By Conor Hale
The FDA is working to prevent potential shortages of medical devices after the closure of an Illinois sterilization plant, which was due to a state environmental protection order.
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J&J Can't Get Pa. Mesh Mistrial Over Expert's Heart Attack
Mar 28, 2019 | Law 360
By Matt Fair
Philadelphia judge has refused to declare a mistrial in an ongoing pelvic mesh injury trial based on what a Johnson & Johnson unit said was its inability to call an expert witness recovering from a recent medical emergency.
Rather than declare a mistrial in the case, which kicked off earlier this month, Judge Kenneth Powell in the Philadelphia County Court of Common Pleas opted on Tuesday to put the proceedings on hold until J&J subsidiary Ethicon Inc.'s expert witness is cleared by his medical team to return to work after suffering a heart attack.
“This arrangement allowed us to avoid a mistrial,” said Tracie Palmer, an attorney with Kline & Specter PC representing plaintiff Susan McFarland, in a statement to Law360.
McFarland filed suit against Ethicon claiming that an allegedly defective TVT-O pelvic mesh sling she received more than a decade ago to treat her urinary stress incontinence sawed through the soft tissue of her vagina, causing scarring and chronic pain.
McFarland’s case, the eighth set of mesh-related claims to go to trial in Philadelphia, has already seen one mistrial after jurors deadlocked last fall on whether or not her injuries had been caused by her implant.
The retrial kicked off earlier this month, but ran into trouble after attorneys for Ethicon reported to the court that Dr. Robert Rogers, a physician tapped to offer his opinions about the cause of McFarland’s injuries, had suffered a heart attack and would not be able to appear as scheduled.
Because Rogers’ doctor indicated he would be unable to work until at least the end of April, Ethicon asked Judge Powell in a filing on Monday to declare a mistrial.
“Given the length of the delay and the inherent uncertainty of recovery and treatment, we cannot see how this trial can continue in a manner that would be fair to the jury, the court, Ms. McFarland, and Dr. Rogers and his family,” the company said.
But McFarland countered that Dr. Rogers, who court filings said would continue to see his own patients in a limited fashion while recovering, should be allowed to provide a videotaped deposition instead of appearing in person.
In the end, however, the court opted to honor the recommendation from Rogers’ doctor that he not resume his work on the case until the end of next month, and put the trial on hold.
A spokeswoman for Ethicon declined to comment.
McFarland and her husband are represented by Tracie Palmer, Braden Lepisto, Shanin Specter and Lee Balefsky of Kline & Specter PC.
Ethicon is represented by Kate Skagerberg of Beck Redden LLP, Adam Spicer, Paul Rosenblatt and Jordan Walker of Butler Snow LLP, and D. Alicia Hickok, Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLP.
The case is Susan McFarland et al. v. Ethicon Inc. et al., case number 130701577, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Editing by Jack Karp.
https://www.law360.com/articles/1143878/j-j-can-t-get-pa-mesh-mistrial-over-expert-s-heart-attack
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Law Firms Objecting to Mesh Fees Accuse Leadership of Self-Dealing, Bill-Padding
Mar 28, 2019 | Law.com
By Amanda Bronstad
Law firms objecting to their share of an estimated $550 million in attorney fees in the trans-vaginal mesh litigation have raised new accusations that lawyers tasked with allocating those funds resorted to self-dealing and bill-padding to line their own pockets.
This week’s filings are the latest skirmish over fees in the multidistrict litigation over mesh devices—specifically, how much each of the 94 plaintiffs law firms that did work for the “common benefit” should get. On March 12, the fee and compensation committee and Daniel Stack, a retired judge on the Madison County, Illinois, Circuit Court, appointed to review the fee allocation process, issued their final recommendations on how to allocate the fees.
But Adam Slater of Mazie Slater Katz & Freeman, based in Roseland, New Jersey, raised questions in a March 26 objection about the allocation process. He wrote that plaintiffs attorney Bryan Aylstock pressured the chairman of the fee and compensation committee, Henry Garrard, to boost the amount of attorney fees to his Pensacola, Florida-based firm, Aylstock, Witkin, Kreis & Overholtz, which ultimately got $10 million more. According to the objection, Aylstock threatened that his colleague, D. Renée Baggett, a member of the fee and compensation committee, would not sign off on its preliminary written recommendation if Garrard refused to increase his firm’s fees.
Mazie Slater partners Adam Slater and David Mazie filed separate declarations insisting that Stack had relayed the information at a Jan. 3 meeting with them.
“Judge Stack stated that he ‘was sickened’ and ‘angered’ by this conduct, which he described as Mr. Aylstock pressuring the FCC chairman when he was particularly vulnerable,” Slater wrote in his firm’s objection. “Judge Stack explained that he could not recommend the far lower amount he believed Aylstock deserved since he was, as he termed it, ‘put in a box’ since the agreement with the Aylstock firm included assurance that Judge Stack would not reduce the agreed-upon award.”
The objection also accused Motley Rice of padding its bills in the mesh litigation.
“Similarly, Judge Stack stated that he believed that Motley Rice (like some others in the litigation) had inflated its contributions and had ‘padded’ its time with thousands of phantom hours,” Slater wrote. Stack told him that Motley Rice did that “in every litigation,” according to the objection.
Slater declined to comment.
Shanin Specter, of Kline & Specter, also filed a March 26 objection that raised similar concerns. Specter is challenging his Philadelphia firm’s $3.7 million fee allocation, despite about $16.4 million in lodestar billing. “At bottom,” he wrote, “Mr. Stack’s report is worthless.”
In an email, Specter wrote that both filings raised new concerns about the fee allocation process.
“Mazie Slater’s and Kline & Specter’s filings contain disturbing evidence of fraudulent billing and improper influence of and wrongful conduct by a court appointed officer,” he wrote. “This evidence casts a dark shadow on these proceedings.”
Both Aylstock and Baggett did not respond to a request for comment. Joseph Rice of Motley Rice in Mt. Pleasant, South Carolina, another member of the fee and compensation committee, also did not respond.
Neither Garrard, of Blasingame, Burch, Garrard & Ashley in Athens, Georgia, nor Stack, in St. Louis, Missouri, responded to requests for comment.
The fee and compensation committee’s response to the objections is due April 9.
On Jan. 30, U.S. District Judge Joseph Goodwin of the Southern District of West Virginia, who is overseeing seven multidistrict litigation proceedings that at one point surpassed 100,000 mesh lawsuits, granted a request from the fee and compensation committee that defendants hold back 5 percent of all settlements and judgments to pay common benefit counsel. Such a holdback, which Kline & Specter had opposed, would grant $366 million in common benefit fees based on the $7.25 billion in settlements so far. The final settlement price tag, though, could be closer to $11 billion, granting about $550 million in fees in the end.
In their objections this week, both Mazie Slater and Kline & Specter insisted that the fee and compensation committee short-changed them, particularly given their work on trials in New Jersey and Pennsylvania state courts. Both objected to the fee amounts granted to the eight law firms on the fee and compensation committee, which got an average award of more than $27 million.
Mazie Slater claimed to be the “catalyst of the overall litigation” and “one of the driving forces and largest risk-takers in the litigation,” filing the first case in the country against Johnson & Johnson’s Ethicon Inc. in 2008. Yet Stack’s report affirmed the committee’s recommendation of $6.02 million. That’s not “commensurate with its status as one of the few fundamental leaders of this litigation,” citing the “astronomic” fees that went to members of the fee and compensation committee, Slater wrote.
“Fair evaluation of Mazie Slater’s contributions overwhelmingly supports a significantly greater award,” Slater wrote. “The inescapable conclusion is that the most important qualification for common benefit fees was a seat on the FCC, or a close affiliation with an FCC member.”
Kline & Specter, in its objection, cited six verdicts the firm obtained for plaintiffs totaling more than $146 million, all in the Philadelphia Court of Common Pleas.
“Kline & Specter played a critical role in the transvaginal mesh litigation,” Specter wrote. “No firm tried more cases than Kline & Specter or won more verdicts.”
The firm raised questions about the methodologies used to calculate the fee allocations and whether Stack, whose official title is “external review specialist,” was too reliant on the fee and compensation committee to be a true neutral. On Feb. 14, Specter filed a motion to appoint a new special master, citing Stack’s “inherent conflict” in having signed the preliminary written recommendation while negotiating with objectors—a move that Garrard called “frivolous” in a response. Specter also asked for more documents that could reveal what firms actually billed.
Goodwin rejected both motions.
“Mr. Stack’s methodology, if one exists, was severely flawed,” Specter wrote in his firm’s objection this week. “Mr. Stack simply rubberstamped the FCC’s recommendations and stated that neither he nor the FCC were required to provide an explanation. This is fundamentally unfair.”
Another firm, Anderson Law Offices in Cleveland, raised similar concerns about Stack in a March 27 objection.
In court papers, Stack defended his actions and the transparency of the fee allocation process. In his recommendation this month, Stack noted that of the 94 firms seeking fees, eight had objected to the fee and compensation committee’s final recommendation and, after negotiating with them, only four, including Kline & Specter and Mazie Slater, remained.
https://www.law.com/2019/03/28/law-firms-objecting-to-mesh-fees-accuse-leadership-of-self-dealing-bill-padding/
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Almost 60 patients have been told by hospital they should not have been operated on
Mar 28, 2019 | The London Economic
By Ben Gelblum
Dozens of women who were given a controversial type of bowel mesh surgery should NOT have been operated on, a hospital trust has admitted.
An 18-month investigation says 57 female patients treated by surgeon Tony Dixon should have been offered alternative treatments before their surgery.
The women told how they were left in severe pain and even disabled after the pelvic floor surgery, using artificial mesh.
Mr Dixon, who was suspended in 2017 following initial concerns, pioneered the use of artificial mesh to lift prolapsed bowels, often caused by childbirth.
His technique is known as laparascopic ventral mesh rectopexy (LVMR), and the surgeries began as far back as the early 2000s.
But, following reports by Mr Dixon’s patients to the BBC about complications and chronic pain after the surgery, North Bristol NHS Trust has carried out a review.
The review investigated cases carried out over a ten-year period from 2007 to 2017.
And now, 18 months on, the Trust has written to Mr Dixon’s patients at Southmead Hospital in Bristol, apologising that the women were given this procedure at all.
The letter begins: “I am very sorry to tell you that in the opinion of the clinical advisory group, you should have been offered alternative treaments before proceeding to surgery.”
And one patient whose life has been damaged by the mess surgery is Paula Goss, 49, from South Gloucestershire – who says she is “disgusted” and “fuming” over the outcome.
Speaking to the BBC, Paula said that she was told the surgery “would change her life and would make everything better”.
But she told the BBC: “I’m disabled in many ways because of it. After five years, I’m still having all the issues. It’s not good enough.
“I’m disgusted, I’m fuming. I feel very angry, very let down, not just physically but emotionally.
“It’s not just the physical pain that you have, it’s your mental pain, because you’re living with it daily.
“You’re having to try and get through each day thinking that you’re okay. It’s a struggle,” she added.
The Trust said that the surgery was carried out successfully on all 57 patients, but added they “should have been offered alternative treatments before proceeding to surgery”.
A further 73 patients have been told their surgery was appropriate, and investigations into 13 other cases are still to be completed.
The vast majority of the operations were carried out by Mr Dixon, but some were performed by a further three surgeons.
The Trust’s medical director, Dr Chris Burton, said he wanted to apologise to patients who received unnecessary surgery.
“It is unacceptable and we are taking it extremely seriously,” he told the BBC.
https://www.thelondoneconomic.com/lifestyle/health/almost-60-patients-have-been-
He added immediate action was taken to “ensure it couldn’t happen again”, and patients have been supported.
“We will keep investigating to ensure we have identified those patients affected by these issues, and to find out what happened to learn lessons for future care.”
Mr Dixon, who also performed operations at Spire Hospital in Bristol, said he was “unable to comment on specific allegations… due to patient confidentiality and while relevant investigations are on-going”.
“There is a need for caution in comparing the use of mesh in different procedures with very different risks and outcomes,” he added.
Spire Healthcare said it was carrying out a similar review which it hoped would be complete in May.
Mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
The mesh, usually made from synthetic polypropylene, is intended to repair damaged or weakened tissue.told-by-hospital-they-should-not-have-been-operated-on/28/03/
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Mar 28, 2019 | Daily Mail
By Joel Adams
More than 50 patients who were given a controversial type of bowel surgery should not have been operated on, a hospital trust has admitted.
Dozens of women say they were left in severe pain after pelvic floor surgery using artificial mesh at Southmead Hospital in Bristol.
Colorectal surgeon Tony Dixon was suspended in 2017 after concerns were first raised and an inquiry examined 143 cases.
Dr Dixon, who also worked at the private Spire Hospital in Bristol, pioneered the use of artificial mesh to lift prolapsed bowels - a technique known as laparoscopic ventral mesh rectopexy (LVMR) - often caused by childbirth.
But he is currently suspended by the General Medical Council from performing certain forms of corrective surgery, and the NHS has referred him to the GMC over mesh procedures.
One of his patients hanged herself after suffering inescapable post-operative pain, after he operated on her and removed her ovaries without her consent.
North Bristol NHS Trust has now told 57 patients they should have been offered alternative treatment first, prior to surgery, following an investigation into their care.
It found that although the operations on 57 people were carried out 'satisfactorily' they 'should have been offered alternative treatments before proceeding to surgery.'
Another 73 patients considered by the review have been told the surgery they received was appropriate.
A further 13 patients have been told that investigations into their cases remain ongoing and will be completed as soon as possible.
The Trust admitted that it was 'unacceptable' that patients who did not require surgery were operated on and have apologised.
After concerns were raised about pelvic floor surgery, the trust began a review of the cases of women and men who underwent the procedure between 2007 and 2017.
Now, 18 months on, the Trust has written to Mr Dixon's patients at Southmead Hospital in Bristol, apologising that the women were given this procedure at all.
The letter begins: 'I am very sorry to tell you that in the opinion of the clinical advisory group, you should have been offered alternative treaments before proceeding to surgery.'
One patient whose life has been damaged by the mesh surgery is Paula Goss, 49, from South Gloucestershire - who says she is 'disgusted' and 'fuming' over the outcome.
Speaking to the BBC, Paula, said that she was told the surgery 'would change her life and would make everything better'.
But she told the BBC: 'I'm disabled in many ways because of it. After five years, I'm still having all the issues. It's not good enough.
'I'm disgusted, I'm fuming. I feel very angry, very let down, not just physically but emotionally.
'It's not just the physical pain that you have, it's your mental pain, because you're living with it daily.
'You're having to try and get through each day thinking that you're okay. It's a struggle,' she added.
The vast majority of the operations were carried out by Mr Dixon, but some were performed by a further three surgeons.
Ms Goss is just one of more than 90 patients being represented by Medical negligence specialists from Thompsons Solicitors - looking into the surgery at Southmead Hospital and the Spire.
Madeleine Pinschof, senior solicitor at the firm and its national coordinator for mesh, added: ‘This is another example of the dangerous complications associated with surgical mesh procedures.
‘This recall is about one or more surgeons at one Trust but it isn’t an isolated issue and needs to be seen as part of a pattern repeated across the UK.’
Dr Chris Burton, medical director of the North Bristol NHS Trust, said: 'I want to apologise to all patients who have received surgery unnecessarily - it is unacceptable and we are taking it extremely seriously.
'We took immediate action to ensure this couldn't happen again and have been supporting patients where they need it.
'We will keep investigating to ensure we have identified those patients affected by these issues, and to find out what happened to learn lessons for future care.'
Mr Dixon, who also performed operations at Spire Hospital in Bristol, said he was 'unable to comment on specific allegations... due to patient confidentiality and while relevant investigations are on-going'.
'There is a need for caution in comparing the use of mesh in different procedures with very different risks and outcomes,' he added.
Spire Healthcare said it was carrying out a similar review which it hoped would be complete in May.
Mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
Law firm Irwin Mitchell represents 49 people who underwent surgery at Southmead and Spire hospitals and called on the trust to 'openly publish its findings'.
Solicitor Sallie Booth said: 'Many patients, including our clients, have had a number of concerns about whether procedures they underwent were appropriate.
'Today's announcement by North Bristol NHS Trust is extremely concerning and understandably has caused a great deal of distress to our clients.
'The trust should now openly publish its findings to the patients concerned - rather than force them to get to the truth only through a stressful litigation process.
'It is welcome that the trust has now made public that 57 needlessly underwent surgery. It is vital that reasons why this was allowed to happen are established.'
Irwin Mitchell has already agreed terms with North Bristol NHS Trust for a scheme to consider compensation.
Ms Booth added: 'From speaking to clients, and through our initial investigations, the use of mesh in this type of surgery potentially has long term adverse consequences and so it is imperative that issues are fully investigated and a clear process established so patient safety is at the forefront at all times.
'It is also vital that those who think that they might have been affected by this issue contact us promptly so that their concerns can be fully investigated before the cases become time barred.'
Mr Dixon built up an international reputation for using mesh rectopexy to fix bowel problems, often caused by childbirth, but is currently suspended from performing this surgery at two hospitals in Bristol.
The General Medical Council (GMC) has stopped him from performing another form of corrective surgery, known as a Starr procedure (stapled transanal resection of the rectum), until November 2019.
The NHS has now also referred him to the GMC over mesh procedures.
A GMC spokeswoman said: 'We are aware of the outcome of North Bristol NHS Trust's investigation and the concerns that patients will be experiencing.
'While our own investigation is ongoing, Dr Dixon has had interim conditions placed on his practice by an interim orders tribunal at the Medical Practitioners Tribunal Service.'
Many clients have advised Irwin Mitchell that they have suffered complications following surgery, while others say that the procedure actually carried out were not what they were expecting, or was undertaken without their knowledge or consent.
One of Mr Dixon's patients killed herself after he removed her ovaries without her knowing during an operation, an inquest heard.
Lucinda Methuen-Campbell, from the village of Three Crosses, near Swansea, went in for surgery on a bowel disorder - but came out without her ovaries.
An inquest heard Mr Dixon told her later that her ovaries were taken out 'because they were in the way.'
Mrs Methuen-Campbell chose surgery at a private hospital performed by pioneering surgeon Tony Dixon in September 2016 after suffering years of pain.
She had a vaginal mesh inserted to help with the bowel disorder but it left her in agony.
The 58-year-old was later found hanged in her attic telling her ex-partner: 'There didn't seem to be a way out of the pain.'
Mrs Methuen-Campbell's ex-partner Philip Chatfield, a sculptor, said: 'The pain continued to get worse and nobody seemed able to solve the problem.
'Mr Dixon performed the operation in 2016 with the mesh but it was unsuccessful and caused her to be in agony. She had a follow-up operation which made things even worse.'
WHAT ARE VAGINAL MESH IMPLANTS?
Vaginal mesh implants are devices used by surgeons to treat pelvic organ prolapse and urinary incontinence in women which are often caused by childbirth.
Usually made from synthetic polypropylene, a type of plastic, the implants are intended to repair damaged or weakened tissue in the vagina wall.
Other fabrics include polyester, human tissue and absorbable synthetic materials.
Some women report severe and constant abdominal and vaginal pain after the surgery.
In some, the pain is so severe they are unable to have sex.
Infections, bleeding and even organ erosion has also been reported.
WHAT ARE THE DIFFERENT TYPES OF MESH?
Mini-sling: This implant is embedded with a metallic inserter. It sits close to the mid-section of a woman's urethra. The use of an inserter is thought to lower the risk of cutting during the procedure.
TVT sling: Such a sling is held in place by the patient's body. It is inserted with a plastic tape by cutting the vagina and making two incisions in the abdomen. The mesh sits beneath the urethra.
TVTO sling: Inserted through the groin and sits under the urethra. This sling was intended to prevent bladder perforation.
TOT sling: Involves forming a 'hammock' of fibrous tissue in the urethra. Surgeons often claim this form of implant gives them the most control during implantation.
Ventral mesh rectopexy: Releases the rectum from the back of the vagina or bladder. A mesh is then fitted to the back of the rectum to prevent prolapse.
HOW MANY WOMEN SUFFER?
According to the NHS and MHRA, the risk of vaginal mesh pain after an implant is between one and three per cent.
But a study by Case Western Reserve University found that up to 42 per cent of patients experience complications.
Of which, 77 per cent report severe pain and 30 per cent claim to have a lost or reduced sex life.
Urinary infections have been reported in around 22 per cent of cases, while bladder perforation occurs in up to 31 per cent of incidences.
Critics of the implants say trials confirming their supposed safety have been small or conducted in animals, who are unable to describe pain or a loss of sex life.
Kath Samson, founder of the Sling The Mesh campaign, said surgeons often refuse to accept vaginal mesh implants are causing pain.
She warned that they are not obligated to report such complications anyway, and as a result, less than 40 per cent of surgeons do.
https://www.dailymail.co.uk/news/article-6859443/More-50-women-left-pain-pelvic-floor-operations-not-gone-knife.html
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Southmead patients told surgery was unnecessary
Mar 28, 2019 | Gazette Series
By Huw Mabe
Fifty-seven patients who received pelvic floor surgery at Southmead Hospital have been told it was unnecessary.
A review by North Bristol NHS Trust found the patients, who had pelvic floor surgery using artificial mesh between 2007 and 2017, should have been offered alternative treatments beforehand.
Another 73 men and women who had the laparoscopic ventral mesh rectopexy (LVMR) procedure have been told the surgery they received was appropriate, while investigations into another 13 cases are ongoing.
North Bristol NHS Trust medical director, Dr Chris Burton, said: “I want to apologise to all patients who have received surgery unnecessarily – it is unacceptable and we are taking it extremely seriously.
“We took immediate action to ensure this couldn’t happen again and have been supporting patients where they need it.
“We will keep investigating to ensure we have identified those patients affected by these issues, and to find out what happened to learn lessons for future care.”
https://www.gazetteseries.co.uk/news/17533359.southmead-patients-told-surgery-was-unnecessary/
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FDA prepares for possible device shortages after gas leaks lead to closure of sterilization plant
Mar 27, 2019 | Fierce BioTech
By Conor Hale
The FDA is working to prevent potential shortages of medical devices after the closure of an Illinois sterilization plant, which was due to a state environmental protection order.
In mid-February, the Illinois Environmental Protection Agency halted operations at the large Willowbrook facility, run by the contract sterilizer Sterigenics, after officials found unacceptably high levels of ethylene oxide gas in the air surrounding the premises.
Ethylene oxide is commonly used to sterilize many medical devices—about half of all of them, in fact, ranging from wound dressings to stents to surgery kits used in routine hospital procedures, according to the FDA—and it's especially useful in sterilizing components made of different materials, or that can’t be cleaned by steam.
The flammable, colorless gas is also used to help manufacture antifreeze, textiles, plastics, detergents and adhesives. Long-term exposure to higher levels can cause irritation, harm the central nervous system and increase the risk of certain types of cancers, according to the federal Environmental Protection Agency.
But effective sterilization and the prevention of infections is critical to the nation’s healthcare system, FDA Commissioner Scott Gottlieb said in an agency statement. “However, the FDA recognizes the environmental considerations that are currently impacting manufacturers’ ability to use this process,” he said.
In response, the agency has been looking to secure alternative locations for the devices processed at the Willowbrook facility, and it is working directly with manufacturers to help them transition their products to another site or another method.
According to the FDA, Sterigenics listed 594 different types of devices that were sterilized with ethylene oxide gas at the plant, including sutures, clamps, knives, stents and needles, but the agency isn’t aware of any related device shortages at this time.
“There’s a risk that for some sterile packaged products that are already in distribution, existing supply may be diminished—or even depleted—as healthcare facilities use their inventory before alternative arrangements can be made accommodate the sterilization of new products coming off manufacturing lines,” Gottlieb said. “This could lead to temporary or ‘spot’ shortages of some products until sterilization can be restored.”
The FDA also noted that a separate facility—an ethylene oxide sterilization plant maintained by Viant in Grand Rapids, Michigan—is scheduled (PDF) to close later this year, following air quality issues raised by the Michigan Department of Environmental Quality. The Viant facility processes 46 types of devices, including catheters and surgical mesh.
The FDA is urging affected medical device manufacturers to begin assessing any potential downstream impacts of the closures on device distribution through their supply chain. The agency is also considering making devices available from other sources to avoid any interruptions.
In addition, the FDA has launched new efforts to encourage companies to develop new and improved sterilization technologies, and it's working with stakeholders to validate methods using lower levels of agents like ethylene oxide to reduce environmental exposure risks.
The agency plans to hold a public innovation challenge later this year, which could include new devices or modalities for sterilizing devices, and will host an advisory committee meeting on the topic. The FDA also launched a new webpage consolidating its information on ethylene oxide use.
https://www.fiercebiotech.com/medtech/fda-preps-for-possible-shortages-after-gas-leaks-lead-to-closure-a-medical-device
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