Preview Newsletter
Ethicon Media Monitoring 10/24/2017
-
Stop telling women their suffering is normal. Pain should be treated
Oct 23, 2017 | The Guardian
By Heba Shaheed
Women’s health is in major need of disruption. For too long women have suffered alone and in silence. Pelvic floor issues are normalised “because you’ve given birth, so what do you expect?” It’s time to break the taboos surrounding pelvic health so that we can enable women to access the high-quality healthcare that they deserve. -
Horwich mum Lisa Aherne shares the pain and tears suffered after pelvic mesh surgery
Oct 24, 2017 | The Bolton News
By Rosalind Saul
A MUM has blamed a surgical implant at the centre of a health scandal for turning her life upside down. -
Plaintiffs’ $27 Mill Boston Scientific Mesh Verdict Upheld!
Oct 23, 2017 | Mesh Medical Device Newsdesk
The trial of four women, implanted with Boston Scientific’s Pinnacle mesh, was held in a Miami court November 2014 before Judge Goodwin, displaced temporarily from his Charleston, WV court, while another mesh trial took place there.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Stop telling women their suffering is normal. Pain should be treated
Oct 23, 2017 | The Guardian
By Heba Shaheed
Women’s health is in major need of disruption. For too long women have suffered alone and in silence. Pelvic floor issues are normalised “because you’ve given birth, so what do you expect?” It’s time to break the taboos surrounding pelvic health so that we can enable women to access the high-quality healthcare that they deserve.
Pelvic issues like incontinence, prolapse, period pain and painful sex are common but they are not normal. Just because a woman menstruates does not mean that period pain is normal. Period pain could be a sign of endometriosis, which affects 10% of women, and has a ridiculously delayed diagnosis of seven to 10 years, leading to chronic pain and infertility.
Women have the right to know about injuries of vaginal birth beforehandSascha Callaghan and Amy Corderoy
Read more
If a woman is sexually active, it is not normal for her to have pain during intercourse. If a woman is pregnant, it does not mean that her back pain is normal. If a woman has given birth, it is not normal for her to have bladder leakage or pelvic organ prolapse. It’s high time we change the language dominating in women’s health.
When we tell a woman that her suffering is normal, we take away her right to receive treatment for her pain. We have a collective responsibility to give the woman the best possible chance to recover and live a healthier, pain-free life.
Pelvic organ prolapse and incontinence affects one in three women, which makes these issues common. What is normal is that two-thirds of women are not affected. Period pain is common and affects one in five girls and women. What is normal is the 80% of women who have pain-free periods. The sooner we reform this culture, the better access women will have to effective solutions.
When it comes to gynaecological issues, apart from doing nothing, the go-to treatment is typically surgery. Evidence-based alternatives such as pelvic floor physiotherapy are rarely provided. If a person was to have a shoulder surgery, they would be prescribed physiotherapy pre- and post-surgery yet pelvic floor issues are rarely afforded adjunct treatment options.
Pelvic physiotherapy is effective in managing pelvic organ prolapse, painful sex, back pain, endometriosis, and a number of women’s health issues. Research by the Australian Physiotherapy Association shows an 84% success rate in the treatment of incontinence. Unfortunately women continue to suffer, with incontinence in women being the largest factor for admittance into nursing homes.
Often women come out of endometriosis surgeries with the same amount of pain, and sometimes more pain. Prolapse surgeries have high recurrence rates, and some women are still incontinent after incontinence surgeries. The common thread is that women were not provided crucial pelvic floor education and rehabilitation.
These surgeries can also have debilitating side effects for women, as demonstrated by the recent vaginal mesh implants scandal. If these women had received physiotherapy before surgery, or better yet, immediately postpartum, many of them could have avoided surgery altogether. Importantly, women who have developed mesh complications may also benefit from pelvic floor physiotherapy.
Surgeries only provide one piece of the puzzle, with the pelvic floor component often overlooked. In women with conditions like endometriosis and vaginismus, the pelvic floor muscles become tight and unable to relax. Unless these muscles are released by a physiotherapist, a woman may continue to experience pain. In women with prolapse and incontinence, the pelvic floor muscles need to be strengthened, preferably before surgery is even recommended.
The World Health Organisation has outlined that there is a global maternal health crisis. In response, a working group of women’s health physiotherapists from four nations was set up with the aim of reducing the physical, psychological and social impact of pregnancy and birth-related injuries. We propose a proactive model to revolutionise postpartum care, similar to a successful model currently available to new mothers in France.
We believe that every woman has the right to receive a women’s health physiotherapy assessment at 20 weeks pregnant and at eight weeks postpartum. This allows for pelvic floor problems to be diagnosed early, for women to receive appropriate preventative advice, and for women to receive early access to evidence-based non-surgical solutions.
In March I conducted a poll surveying 800 women where I asked them if they would like to know about their individual risk factors for birth-related pelvic floor problems. 85% of women indicated they wanted to be informed before birth and only 2% indicated that being informed would scare them.
This poll clearly demonstrated that our failure to educate women prenatally of birth-related pelvic floor injury systematically strips them of their autonomy. This is further confirmed by the statement I hear most commonly by my clients: “Why didn’t anyone tell me this could happen?” Education is key to progress, especially in healthcare, and a woman has the right to be informed, so that she can prepare for her future.
https://www.theguardian.com/commentisfree/2017/oct/24/stop-telling-women-their-suffering-is-normal-pain-should-be-treated
-
Horwich mum Lisa Aherne shares the pain and tears suffered after pelvic mesh surgery
Oct 24, 2017 | The Bolton News
By Rosalind Saul
A MUM has blamed a surgical implant at the centre of a health scandal for turning her life upside down.
Since undergoing an operation which saw her fitted with a surgical mesh, Lisa Aherne has lost her job, nearly lost her home and has been left living in constant pain.
The former care assistant from Horwich underwent a hysterectomy on July 16, 2014 – her 44th birthday – at Beaumont Hospital during which time she was also fitted with the mesh in her pelvic region after doctors found a small prolapse.
Immediately after the procedure she noticed something was wrong and suffered 'horrendous pain' but was told it was part of the recovery process.
Two years down the line the 47-year-old is unable to walk, sit or eat without suffering pain down her right-hand side.
She said: "I can feel it pulling on the right-hand side in my groin area. It feels like a fish hook inside of me pulling all the time while the pain down my leg into my foot comes and goes. I also get back pain.
"It feels like the organs are being pulled about in my stomach. I have no idea what damage it is doing. I can't go out to the shops or walk about everywhere. It's not a nice feeling at all.
"When eating food I can't sit straight up, I have to lean to one side, which means I don't go to restaurants any more because of the discomfort.
"This has absolutely changed my life, there have been tears.
"It's horrible, it feels like your life has been taken away from you. You go from enjoying your job and a happy life to feeling totally lost with no answer.
"People like me, we are only the tip of the iceberg. This had affected both men and women."
According to the NHS, synthetic meshes are used to support the vaginal wall and/or internal organs for surgery to a pelvic organ prolapse.
About 1,500 operations are carried out in the UK each year but the Medicines & Healthcare products Regulatory Agency has received reports of complications associated with vaginal meshes – these include persistent pain, sexual problems, mesh exposure through vaginal tissues and occasionally injury to nearby organs, such as the bladder or bowel.
International concern has been mounting over the severe complications and on Wednesday the Government rejected a call for an inquiry and ban on the implants following a debate by MPs in the House of Commons.
In Mrs Aherne's case, she was told by the medical team that they would repair the prolapse but says there was no warning that it would involve using the mesh or what side effects it could cause.
It was only after reading the medical notes that the mum-of-two discovered she had been fitted with a prolene — synthetic — implant which she blames for the complications.
She explains: "There was a consent form and I signed it, but I listened to my consultant and, I know you should read the small print, but you trust the consultant to do what's best and I had no inclination.
"I wish I could go back three years knowing what I know now, I would never have agreed to it.
"If someone said there was a risk of destroying the intimacy with your husband and the loss of your job I would have said forget it!"
The pain, and resulting problems with mobility in Mrs Aherne's right leg, forced her to leave work after 25 years and the drop in earnings nearly resulted in the loss of the family home.
She can no longer walk long distances without discomfort, often relying on walking aids or a scooter, and the problems have also put pressure in her marriage.
Over the last two years she was repeatedly sought the help of healthcare professionals, being passed from specialist to specialist, and even undergone a second operation at the Royal Bolton Hospital.
All she has ended up with is a diagnosis of depression, anxiety and chronic fatigue, which she argues against, and has vowed to continue the fight to have the mesh removed and is seeking legal advise.
She adds: "I walked in there a very fit lady, running miles a day, doing a physical job, never been overweight, I don't drink and I had quit smoking in 2011.
"I'm not depressed, I'm lost if anything and very frustrated. I kept saying it was something to do with the operation and they kept saying no it wasn't.
"There are questions that can never be answered. It's horrible, really horrible. I want a chance to at least try to get some of my life back."
http://www.theboltonnews.co.uk/news/bolton/15612767._It_feels_like_a_fish_hook_inside_of_me_pulling_all_the_time______Mum_reveals_pain_and_tears_suffered_after_mesh_implant_operation/
-
Plaintiffs’ $27 Mill Boston Scientific Mesh Verdict Upheld!
Oct 23, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, October 21, 2017 ~ The trial of four women, implanted with Boston Scientific’s Pinnacle mesh, was held in a Miami court November 2014 before Judge Goodwin, displaced temporarily from his Charleston, WV court, while another mesh trial took place there.
Each of the four women was awarded compensatory damages in excess of $6 million.
Last week, the mesh trial jury verdict of $27 million against Boston Scientific (BSC) was upheld by the Eleventh Circuit Court of Appeals from the Southern District of Florida.
The case was Eghnayem, Dortes, Nunez and Betancourt, (Eghnayem v Boston Scientific 2:13-cv-07965). All four women had been implanted with the Pinnacle pelvic mesh, used to treat pelvic organ prolapse (POP). All four women had complications including pain, infection, mesh erosion, dyspareunia and mesh shrinkage.
Originally filed in the Southern District of West Virginia in multidistrict (MDL) litigation, the case consolidating the plaintiffs and was transferred to the Southern District of Florida for trial.
On November 13, 2014, after an eight-day trial, the jury found for each of the plaintiffs on four claims, deciding that the Pinnacle Pelvic Mesh Repair Kit was defectively designed, that its instructions to physicians were also defective, that the company was negligent, and failed to warn patients about the dangers of the Pinnacle.
The plaintiffs were awarded different amounts of compensation ranging from $6.5 million to $6.8 million each.
Boston Scientific immediately filed to overturn the judgment, which was denied, then to appeal the verdict.
See Mesh New Desk coverage here and here.
Boston Scientific claimed there were errors in the verdict, that the four women should not have been tried together, that the exclusion of the Food and Drug Administration’s clearance of Pinnacle through the 510(k) was omitted from the evidence, and that Eghnayem did not prove her claims.
Publishing the U.S. District Court decision October 19, 2017, Judge Judge Stanley Marcus wrote:
“After thorough review, and having had the benefit of oral argument, we can discern no error in the district court’s rulings, and accordingly we affirm the judgment.”
In upholding the jury verdict, the appeals court supported the decision of Judge Joseph Goodwin, of the Southern District of West Virginia, the federal court where the multidistrict pelvic mesh litigation is centered and more than 104,000 cases have been filed.
Boston Scientific had tried to sever the four cases claiming they were different.
A district court may consolidate multiple actions that involve a “common question of law or fact,” wrote Marcus, and that decision is “purely discretionary.” The different jury awards showed that jurors considered each plaintiff individually, says the decision.
BSC wanted jurors to hear that the FDA cleared its Pinnacle mesh, hoping some form of an FDA acknowledgement might influence the jurors, but the appellate panel said the 510(k) is “not a safety regulation, approval under that process cannot show that BSC performed sufficient testing or complied with applicable safety regulations.”
Besides, this is not a case about federal regulatory compliance and other courts have also rejected including the 510(k) evidence under Rule 403 (Bard 4th Circuit 2016).
“The long and short of it is that the district court properly exercised its broad discretion in consolidating these actions and refusing to admit FDA evidence, and the contested fact questions were properly presented to the jury,” Marcus concluded.
The warnings in the IFU (Instructions for Use) do not “even remotely suggest that removal might be impossible,” wrote Marcus, referring to a failure to warn.
Daniel Rogers of Shook Hardy & Bacon in Miami spoke for Boston Scientific at oral arguments in May. Rebecca Vargas of Kreusler-Walsh Compiani & Vargas in West Palm Beach argued for the women, including her client Amal Eghnayem.
Rogers has filed a notice that Boston Scientific has reached a tentative settlement with the last of the four women.
THE 2014 MIAMI TRIAL
During the eight-day trial, the four women claimed painful intercourse, pain, incontinence, infections and mesh exposure after being implanted with the Boston Scientific polypropylene plastic mesh used to treat pelvic organ prolapse (POP).
Dr. Dennis Miller, was presented on videotape. As the inventor of the Pinnacle, he benefited as a Boston Scientific consultant and preceptor and trained other doctors on the Pinnacle.
In all, 25 witnesses were called for the plaintiffs to testify about the Pinnacle design, its chemical characteristics and potential dangers.
Pathologist, Dr. Vladimir Iakovlov, (see MND story here) brought his microscope into the courtroom to show slides of what happens to the polypropylene material as it undergoes oxidative degradation and mesh erosion. He explained the foreign body response, incited by the presence of mesh, causes inflammation.
What results is scar tissue that encapsulates the mesh as the body tries to distance itself from the invader. See a study he authored in 2013: Mesh is Not Inert.
Scar tissue, also called fibroblasts, move into the mesh holes and cement it into place, making treatment very difficult, said expert, Dr. Tom Margolis.
Ultimately, the jury heard that while Boston Scientific studied different waves, weights and pore size of polypropylene mesh, those 2002 studies did not address the Marlex that would eventually be used in the Pinnacle, and did not involve human trials but rather the implantation in the abdomen of rabbits.
The rabbits were sacrificed at two weeks, six weeks and 12 weeks, so there was no assessment of the long-term effect on the rabbits.
BOSTON SCIENTIFIC
BOSTON SCIENTIFIC
Meanwhile, during the same November 2014 time period, the trial of four other women was underway in Charleston, West Virginia.
Jacqueline Tyree, and the others, claimed their Boston Scientific Obtryx Mid-Urethral sling used to treat stress urinary incontinence, was defective.
They were awarded more than $18 million by the Charleston jury.Boston Scientific is one of seven mesh manufacturers facing product liability cases filed over their proprietary mesh products. As of today, there are 25,274 cases pending in the MDL court with 15,811 listed as closed, which may mean they are in the process of being settled.Last May, BSC announced it would settle 37,000 of its outstanding cases. See MND story here.
Boston Scientific Trials So Far
The Eghnayem Miami trial was the first federal bellwether for Boston Scientific, designed to gauge how juries would respond to the evidence and the relative value of the cases.
Boston Scientific had two successful outcomes earlier in 2014 in a Massachusetts courtroom.
In the trial of Maria Cardenas, the jury decided that BCS provided adequate warnings about its Obtryx product. The jurors were not allowed to see the Material Safety Data Sheet during the proceedings, which carried a warning the raw polypropylene plastic material was not to be used to make medical devices. Background here.
In July 2014, Boston Scientific was successful in its Pinnacle Pelvic Floor Repair Kit trial filed by Diane Albright and heard in Middlesex Co. in Massachusetts, where Boston Scientific is headquartered. See background story here.
An unprecedented $73.5 million jury award in the Martha Salazar v. Boston Scientific broke the Boston Scientific winning streak last September 2014 in a Dallas courtroom. That jury award has since been reduced by half due to caps on awards in Texas.
Salazar v Boston Scientific (DC 12 14349). Martha (Rodriguez) Salazar et al (Feliz Salazar, husband) v Jorge Lopez, MD et al (Boston Scientific) filed over the Obtryx® Transobturator Mid-Urethral Sling (MUS) System story here and here.
Pinnacle Mesh
The Pinnacle Pelvic Floor Repair Kit, cleared by the FDA 510(k) process to market in 2007, is no longer on the market in the U.S.
The polypropylene mesh implant was cleared based on it being “substantially equivalent” to another device already on the market.
On May 10, 2011, Boston Scientific sent an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED” letter to all affected customers concerning its Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because ‘the device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.”
Boston Scientific still sells a number of mid-urethral slings for the treatment of incontinence including:
Advantage Fit (transvaginal mid-urethral sling)
Lynx – transvaginal mid-urethral sling
Obtryx II (transobturator mid-urethral sling)
Solyx (single-incision sling system).
Boston Scientific’s ProteGen was the first mesh sling to be manufactured by any mesh maker but it was pulled from the market in 1999 after problems. That did not stop other companies from naming it as a “predicate device” upon which to base their own mesh products. ###
https://www.meshmedicaldevicenewsdesk.com/boston-scientific-mesh-trial-27-mill-upheld/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested