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Ethicon Media Monitoring 5/18/2018
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Boston Scientific Speaks Out About Pelvic Mesh Controversy
May 18, 2018 | Medical Device and Diagnostics Industry
By Amanda Pedersen
It has been an interesting week for Boston Scientific, but not for the reasons you might think. -
Health Minister cancels meeting with women who suffered vaginal mesh complications
May 17, 2018 | The Journal.ie
By Michelle Hennessy
THE MINISTER FOR Health has cancelled a meeting he was due to have with women who suffered complications after vaginal mesh surgeries. -
'Women are in excruciating pain' - Protesters call for immediate suspension of use of transvaginal mesh
May 17, 2018 | Independent.ie
By Kyle Ewald
Protesters gathered outside of Leinster House today to call for the immediate suspension of the use of transvaginal mesh and the “using of women of Ireland as guinea pigs and ignoring their suffering”. -
Guardian science reporter wins prize for vaginal mesh investigation
May 17, 2018 | The Guardian
By Matthew Weaver
The Guardian’s science correspondent Hannah Devlin has scooped a coveted prize in the Association of British Science Writers awards for her investigation into the vaginal mesh scandal. -
Dr Peter Petros faces third disciplinary action since 2005 after pelvic mesh surgery complaints
May 18, 2018 | Newcastle Herald
A DOCTOR whose experiments on 13 large dogs in the 1980s led to pelvic mesh devices at the centre of a global mesh scandal will front a tribunal after the NSW health regulator launched professional misconduct action. -
Are you a woman in your 50s? Here's what you need to know about your health
May 17, 2018 | WTVD-TV
By Tisha Powell
Relieving stress and maintaining a healthy mind and body can help as the body changes and goes through menopause.
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Boston Scientific Speaks Out About Pelvic Mesh Controversy
May 18, 2018 | Medical Device and Diagnostics Industry
By Amanda Pedersen
It has been an interesting week for Boston Scientific, but not for the reasons you might think.
Yes, the company had to go on the defensive this week after CBS aired a 60 Minutes report raising concern over its transvaginal mesh products. The report accused Boston Scientific of buying counterfeit materials from a Chinese supplier to make the mesh devices. But the company has also received a show of customer support, said Dave Pierce, president of Boston Scientific's urology and pelvic health division.
"What's been encouraging this week, amidst all of the concern, and rightly so, has been the commitment and the confirmation by many of the surgeon customers that we have about how important Boston Scientific is in this space and how important it is to have an industry leader remain in this area so that women continue to have these options available to them," Pierce told MD+DI.
The American Urogynecologic Society (AUGS) also released a statement from its president, Charles Rardin, MD, this week that takes issue with the 60 Minutes report.
"We are concerned that the broadcast could lead many patients to believe that implants they have received are inherently defective as a result of the manufacturer, and are more likely to either dissolve and disappear or, conversely, to create permanent complications," Rardin said in the association's statement. "AUGS cannot comment on the manufacturing and regulatory decisions or processes of any manufacturer. However, AUGS has no reason to disagree with the FDA’s conclusions based on a more robust interpretation of data, that currently available mesh poses no new safety concerns."
These products, which tend to get lumped together as "pelvic mesh," are designed to treat women who suffer from pelvic organ prolapse or stress urinary incontinence. The implants are made with polypropylene resin, which has previously been linked to some patient complications.
Boston Scientific uses a particular brand of polypropylene in its devices called Marlex that it initially bought from a Texas-based subsidiary of Chevron Phillips.
"We realized in 2011 that our existing supply of Marlex was going to run out within a few years," Pierce said. "We went back to our original distributor and they were no longer in a position to supply this particular formulation of Marlex and our team then went on a worldwide search to find a stockpile of this Marlex."
That search led to Emai Plastic Raw Materials, a distributor in China that had Marlex in bulk. Pierce said the company first purchased a small amount of Emai's product and hired Cambridge Polymers to test the material and ensure it was the same as the Marlex previously purchased from Chevron Phillips.
Variation Among Marlex Batches Was Expected
Pierce told MD+DI that Boston Scientific had Cambridge Polymers test eight parameters of the Emai-sourced Marlex, not 11 parameters as 60 Minutes reported. And yes, there were some variations.
"When you think about mass-produced commercial resin, you would expect some variation among the batches tested," Pierce said. "We looked at, basically, multiple batches from the original distributor and from Emai."
The tests did show some small variation between the Emai-sourced Marlex and the Phillips batches of Marlex, he said, but there were similar variations from one Phillips Marlex batch to another.
"So this is very much to be expected," he said. "But I think what is critical to know is that all tested materials met the Phillips specification for this formulation."
Furthermore, Pierce said, FDA conducted an 18-month investigation to evaluate the material and concluded in September 2017 that it was the same formulation that Boston Scientific had always used. Had the agency found the materials to be different, Boston Scientific would have been required to file an additional 510(k) application, he said.
Why Did Boston Scientific Overbag the Emai-Sourced Marlex?
It is true that Boston Scientific decided to "overbag" the Emai-sourced Marlex when it exported the material out of China and imported it into the United States. But Pierce said that was done to protect the product from damage during shipping, not to hide anything from customs officials, as 60 Minutes reported.
When Boston Scientific bought the initial, smaller supply of Emai-sourced Marlex, the product was transported by air and the packaging sustained some damage during that shipment. The company didn't want to risk the same thing happening with the larger shipment, which was transported by sea, he said. The overbagging process was "well documented," and did not prevent customs officials from inspecting the shipment, Pierce said.
"We stand by the process through which we exported from China and imported into the United States," he said, adding that the company followed both Chinese and U.S. regulations and has never been contacted by customs authorities from either country regarding those shipments.
It does seem likely, however, that the Emai-sourced Marlex was not in its original packaging from Chevron Phillips.
"Typically this resin, this raw material, is shipped in very, very big quantities and when it gets to a distributor the distributor typically will repackage based on what their downstream customer is looking to acquire," Pierce told MD+DI. "So Emai packaged the raw material in bags for sale to multiple customers, including Boston Scientific."
Boston Scientific Could Have Jumped Ship, But Didn't
"Many years ago when the FDA put out a medical device directive regarding the use of mesh for pelvic organ prolapse and stress urinary incontinence, several manufacturers chose to leave the space," Pierce said. "We faced that exact same decision."
In many ways, it would have been a lot easier for the company to just exit the transvaginal mesh business. Instead, the company elected to stay in the space and work with FDA and medical societies like AUGS to address the concerns associated with the products.
"And we did so because we felt like females who have these issues need options and we're proud of the fact that we stayed in this business," Pierce said.
Keeping the mesh implants on the market has required a significant investment on Boston Scientific's part, he added, as the company has conducted studies mandated by FDA to prove the products' safety and efficacy, the results of which will be available to the public later this year. The company has also worked with AUGS to ensure that surgeons who use the products have extensive training, he said.
"You've seen other companies leave the space altogether. It would have been easier to do that," Pierce said. "But we, as an executive committee, made the decision to stay in this, to absorb the additional expense and complexity, because it's the right thing to do for women."
https://www.mddionline.com/boston-scientific-wants-you-know-few-things-about-controversial-pelvic-mesh
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Health Minister cancels meeting with women who suffered vaginal mesh complications
May 17, 2018 | The Journal.ie
By Michelle Hennessy
THE MINISTER FOR Health has cancelled a meeting he was due to have with women who suffered complications after vaginal mesh surgeries.
Vaginal mesh devices are used in surgeries to treat stress urinary incontinence and pelvic prolapse, conditions women can suffer after natural childbirth. There have been thousands of reports internationally of painful complications from women who have undergone these procedures.
This includes a number of Irish women, some of whom have spoken to TheJournal.ie in the last year about their recurrent urinary infections and pain after the operations.
Solicitor Melanie Power, who set up the Mesh Survivors Ireland and who is representing a number of impacted women in their legal actions against the State, was due to meet today with Simon Harris and Chief Medical Officer Tony Holohan.
She had arranged to bring a small group of women with her so that their experiences could be taken into consideration in the CMO’s report.
“Unfortunately, due to the Cervical Check issues Minister Harris and the Chief Medical Officer had other engagements and this meant our appointment had to be cancelled,” she said today at a protest by the group outside Leinster House.We have been given a rescheduled date now for the 6th of June and hopefully we will be able to express to them our concerns and the opinions of the ladies of Mesh Survivors Ireland and the deep pain they are suffering as a result of this device.
“They are very much feeling abandoned by the healthcare system here and they want a retrospective audit to be carried out on the women implanted so we can speak from a position of knowledge as to what are the actual real risks and complications with this device,” Power said.
Media coverage of these stories promoted Health Minister Simon Harris last year to order a report into the use of vaginal mesh devices in Ireland by the CMO. Now the women who are impacted by complications are worried about how long this review may take.
“We’ve been waiting a long time to have this meeting. With regards to the CMO’s report, it was requested in November, we have no idea as to when it will be completed so that is something I’d be very keen to discuss with the CMO, particularly who he has spoken to because as yet he hasn’t contacted any of the people who are suffering as a result of this device,” Power said.
That was something I wanted to get across with him, that a report needs to take on board the end user of the device and the people suffering as a result of it.”
Power said since the story broke in Ireland, she has been contacted by many women who had silently accepted their symptoms, until they read about other women who spoke to the media.
“We have over 300 members in the [Facebook] group at the moment and that really isn’t a reflection of the numbers that have contacted me because a lot of the people are actually in the older age bracket and aren’t on social media,” she said.
The Department of Health said the meeting was cancelled “owing to urgent other work commitments and has been rescheduled for early June”.
http://www.thejournal.ie/vaginal-mesh-5-4019677-May2018/
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May 17, 2018 | Independent.ie
By Kyle Ewald
Protesters gathered outside of Leinster House today to call for the immediate suspension of the use of transvaginal mesh and the “using of women of Ireland as guinea pigs and ignoring their suffering”.
The protest was in response to the cancellation of a meeting between Minister for Health Simon Harris, the Chief Medical Officer and members of Mesh Survivors Ireland. The meeting was originally scheduled for today, but cancelled on Tuesday and has been rescheduled for June 6.
Transvaginal mesh is used to treat pelvic organ prolapse (POP) and stress urinary continence (SUI), two conditions often experienced by women after a hysterectomy, menopause or childbirth. HSE figures show that around 2,000 of these apparatuses were implanted in 2015 alone with the exclusion of privately-conducted procedures.
In November, Minister Harris asked Chief Medical Officer Dr Tony Holohan to investigate the concerns around the use of mesh implants, but the procedure is still allowed in Ireland.
Solicitor and organiser of the Mesh Survivors Ireland group, Melanie Power has launched the national campaign to suspend the usage of pelvic mesh until the claims of mesh-related suffering can be investigated.
Speaking to Independent.ie, Ms Power said: “Women desperately need to be aware of the damaging side-effects others are feeling as a result of these devices.”
“Women are in excruciating pain and can’t carry on with their lives. There are women who can’t get out of bed in the morning without morphine, it’s just horrendous.”
Over 300 women have joined Mesh Survivors Ireland since its creation and have shared experiences of infection, bowel perforation, bladder perforation, erosion of vaginal tissues and unexplained pain.
Josephine Kilroy, a member of the group, has spent over 288 days in hospital since August 2017 following “unbearable pains” in her stomach and bowel.
Ms Kilroy had the transvaginal mesh inserted in November 2007 and began to develop strong pain in the area in 2010. Between 2010 and 2017 she would visit the hospital five to six times a year for extended period to receive treatment to manage the pain, but has been permanently situated in University College Hospital in Galway since September 2017.
“I haven’t seen my home in 288 days,” Ms Kilroy told Independent.ie. “My mother died in February and I was in so much pain I couldn’t even make it to the funeral, it was heart-breaking.”
“I had my own business for 24 years, worked part time, had a lovely home, and I just feel like I lost everything to this pain.”
In the UK, the NHS have confirmed that 3,000 women have had their mesh removed as a result of the symptoms caused. A warning was issued in the US stating that the transvaginal insertion exposes patients to a greater risk compared to traditional non mesh repair.
Independent.ie reached out the HSE for contact, but has not received a response at this time.
“I just want the HSE to acknowledge the pain and suffering we have gone through, I feel as though we’ve all been let town and we deserve to be treated like people,” said Ms Kilroy.
https://www.independent.ie/irish-news/news/women-are-in-excruciating-pain-protesters-call-for-immediate-suspension-of-use-of-transvaginal-mesh-36918023.html
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Guardian science reporter wins prize for vaginal mesh investigation
May 17, 2018 | The Guardian
By Matthew Weaver
The Guardian’s science correspondent Hannah Devlin has scooped a coveted prize in the Association of British Science Writers awards for her investigation into the vaginal mesh scandal.
Her report exposing NHS data on how thousands of women have undergone surgery to have vaginal mesh implants removed won in the category of best investigative journalism.
The figures Devlin unearthed last August suggested that about one in 15 women fitted with the most common type of mesh support later required surgery to have it extracted due to complications.
In its citation the judging panel described Devlin’s work as “a persistent investigation that uncovered an important story of public interest that might never otherwise have come to light”.
Devlin’s reporting raised awkward questions about the sponsors of the awards Johnson & Johnson, the medical devices multinational which is believed to produce the majority of vaginal mesh products used in the UK.
The company is fighting a major class action in Australia and could face legal proceedings in the UK.
At the time Johnson & Johnson said: “We empathise with those patients who have had complications associated with pelvic mesh procedures, but we believe it is important to recognise that their experiences do not speak for the vast majority of women whose lives have been improved through treatment with pelvic mesh devices.”
Devlin thanked the women who shared their stories of how they had been affected.
The association also awarded a posthumous life achievement prize to Steve Connor, the former science editor of the Independent who died in 2017.
His award was presented to his widow, Ines Connor, by Tim Radford, his former counterpart at the Guardian.
The chair of the judging panel, Mićo Tatalović, praised the calibre of the record 300 entries. “The sheer number of entries and their overall high quality did, of course, make judging tricky, but I am confident the panel has made the right choices,” he said.
A full list of the winners is published on the association’s website.
https://www.theguardian.com/science/2018/may/17/guardian-science-reporter-wins-prize-for-vaginal-mesh-investigation
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Dr Peter Petros faces third disciplinary action since 2005 after pelvic mesh surgery complaints
May 18, 2018 | Newcastle Herald
A DOCTOR whose experiments on 13 large dogs in the 1980s led to pelvic mesh devices at the centre of a global mesh scandal will front a tribunal after the NSW health regulator launched professional misconduct action.
Retired gynaecologist and University of NSW Professor Peter Petros, 78, will appear at the NSW Civil and Administrative Tribunal for the first time next week.
The tribunal directions hearing comes more than four years after the NSW Health Care Complaints Commission received complaints against Dr Petros linked to surgery using a pelvic mesh device he invented, the Tissue Fixation System (TFS). Rights to the device are owned by former Newcastle Falcons basketballer Paul Zadow whose company, TFS Manufacturing, is appealing its cancellation in 2014.
The HCCC move against Dr Petros is the third time he has faced disciplinary action since 2005, including discontinued Medical Board of Australia professional misconduct proceedings against him in 2011.
The case against Dr Petros follows a professional misconduct tribunal hearing against his colleague, gynaecologist and former University of Newcastle Associate Professor Richard Reid, which in April heard at least one woman was left with severe and permanent injuries after pelvic mesh surgery in 2013 by the two men.
The woman was implanted with the TFS device, invented by Dr Petros in 2003 as a “re-engineering” of an earlier device, the Intra Vaginal Sling (IVS). Dr Petros developed the IVS in Western Australia in the late 1980s after experiments on 13 large dogs.
The IVS was marketed by the Australian Medical Association as a “medical design breakthrough” to treat women’s incontinence and prolapse, despite reports of serious complications in women in Western Australian public hospital trials from as early as 1989.
It was later sold to an American company and used to approve a number of pelvic mesh devices to treat prolapse after childbirth, before legal action by women and regulatory action led to its removal from the market. AMA president Dr Michael Gannon conceded in 2017 that AMA endorsement of the IVS device was “a long way from our proudest hour”.
After disciplinary proceedings against Dr Petros in 2006 the Medical Board of Western Australia found he could be criticised for the way he informed women patients about the risks of pelvic mesh surgery using the IVS device but “his conduct did not amount to gross carelessness or incompetency”.
His application for the board to pay his legal costs was dismissed.
The Medical Board of Australia “consented to the discontinuation of professional misconduct proceedings” against Dr Petros in 2011 but was not required to make public its reasons for doing so, the Australian Health Practitioner Regulation Agency said.
In a 2004 civil case against Dr Petros a Western Australian District Court judge awarded a woman more than $136,000 after evidence of severe and permanent injuries following IVS pelvic mesh surgery by him. The court heard Dr Petros received a royalty from each device implanted. The judge found Dr Petros “lacked a complete understanding of the obligation owed by a medical practitioner to a patient contemplating surgery”.
In an application to the State Medical Board of Ohio in 2012 Dr Petros said WA Public Health Services was handling a claim by one former woman patient alleging injuries because of mesh surgery by him at a public hospital using one of his pelvic mesh devices. The matter was settled.
At a Senate pelvic mesh inquiry hearing in September a University of NSW colleague of Dr Petros’, Dr Darren Gold, said Dr Petros had been “vilified, ostracized and tormented for daring to contradict the established thinking” on women’s pelvic surgery by developing an “integral theory” that underpinned his devices.
“In any other country he would have already been awarded a Nobel Prize; here he gets destroyed,” Dr Gold said.
But the inquiry heard evidence from women who blamed Dr Petros’s procedure for “their crippling condition”, said Senator Derryn Hinch, who successfully argued for an inquiry.
Dr Petros declined to comment on the HCCC proceedings.
“We’ll see how that goes,” he said.
The NSW Civil and Administrative Tribunal is expected to hand down its decision on Dr Reid later this year after 18 women complained following pelvic mesh surgery.
TFS Manufacturing’s appeal against the TFS device’s cancellation in 2014 is being heard in the Australian Civil and Administrative Tribunal in Adelaide this week.
https://www.theherald.com.au/story/5406710/second-pelvic-mesh-surgeon-faces-professional-misconduct-hearing/
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Are you a woman in your 50s? Here's what you need to know about your health
May 17, 2018 | WTVD-TV
By Tisha Powell
MENOPAUSE
Relieving stress and maintaining a healthy mind and body can help as the body changes and goes through menopause.
"You're labeled as menopausal if you have absolutely no cycle or no spotting for at least 12 months" according to WakeMed internist Dr. Tehmin Adnan.
Dr. Adnan said that for some women, the symptoms of menopause can be miserable not only for them but those around them as well. "You're family and colleagues will be complaining that you are moody, hot flashes, sleep disturbance," she said.
CHANGES TO YOUR BODY
Experts said many women may find changes in their libido.
Women could also see other changes in their body that may influence their desire to have outercourse, and additionally, have issues with vaginal dryness.
WakeMed OBGYN Dr. Chantel Roedner said there is help for these symptoms. "The gold standard for vaginal dryness or vaginal atrophy is topical estrogen. There are other hormonal placement options available for women if they are suffering from the very severe mood swings, hot flashes, night sweats. There's some evidence hormonal therapy can help with libido as well" Roedner said.
PELVIC FLOOR DISORDER
More serious issues that may affect women in their 50s are pelvic floor disorders.
Urogynecologist Dr. Andrea Crane said pressure in the pelvic floor for older women can lead to incontinence and pelvic organ prolapse in older women.
"Their tissues when they've gone through menopause become weaker and so it's less resilient to counteract the pressures that you do as an active woman," Dr. Crane said because as many as one in four women will suffer a pelvic floor disorder.
For some, a nonsurgical option such as a pessary can help. "You bend it like a taco, put it into the vagina and it opens up and it helps to lift everything up," said Dr. Crane.
COLONOSCOPY
Women turning 50 should also schedule a colonoscopy.
Dr. Adnan said that if your results are normal, you're good for 10 years.
In addition to taking care of your colon, make sure you're getting enough calcium.
"If you are taking in some form of like yogurt, milk, cheese then you're fine, but if you're not you better supplement," said Dr. Adnan.
As women get older osteoporosis can cause fractures that can be slow to heal.
Dr. Adnan has recommended the new shingles vaccine for everyone 50 and older.http://abc11.com/health/are-you-a-woman-in-your-50s-heres-what-you-need-to-know-about-your-health/3484471/
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