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11th Circuit Court of Appeals upholds ruling against Boston Scientific
Nov 15, 2017 | Florida Record
By David Hutton
The U.S. 11th Circuit Court of Appeals has upheld a lower court’s ruling that consolidated cases filed by four women who alleged injuries by a defective pelvic mesh implant by Boston Scientific Corp. -
Almost 7,000 women in NI had vaginal mesh implants
Nov 16, 2017 | BBC
By Marie-Louise Connolly
Almost 7,000 women in Northern Ireland have had vaginal mesh implants in the last decade. -
This once-common surgical material can cause a lifetime of pain
Nov 16, 2017 | SheKnows
Because I watched a lot of daytime TV during certain parts of my life, I remember and sometimes still see commercials for law firms offering to defend folks who had been injured via transvaginal mesh implants.
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11th Circuit Court of Appeals upholds ruling against Boston Scientific
Nov 15, 2017 | Florida Record
By David Hutton
The U.S. 11th Circuit Court of Appeals has upheld a lower court’s ruling that consolidated cases filed by four women who alleged injuries by a defective pelvic mesh implant by Boston Scientific Corp.
The 11th Circuit ruling also upheld a ruling by a U.S. District Court for the Southern District of Florida jury in 2014 that awarded four women a $27 million verdict in the case.
The jury did deny the women punitive damages.
The panel hearing the case included Justices Frank M. Hull and Stanley Marcus. Justice John M. Rogers, U.S. circuit judge for the Sixth Circuit, was sitting by designation. Marcus wrote the opinion.
On appeal, Boston Scientific sought a new trial and alleged the lower court erred when it consolidated the cases of the four plaintiffs. It also maintained the judge was wrong to explode evidence connected to the Food and Drug Administration’s clearance of the Pinnacle Pelvis Floor repair kit for sale through a “substantial equivalence” process.
However, the plaintiffs, according to the opinion, made the same basic claim that the Pinnacle kit was defective and lacked sufficient warnings.
Marcus noted that the lower court rejected the FDA evidence under both Federal Rule of Evidence, which notes that irrelevant evidence isn’t admissible, and Federal Rule of Evidence 403, which, according to court documents, details that relevant evidence may be excluded “if its probative value is substantially outweighed by a danger of unfair prejudice, confusing the issues, misleading the jury, undue delay, [or] wasting time.”
In upholding the ruling, the appeals court panel ruled the Florida court wasn’t out of bounds in its decision.
“The district court acted well within its discretion in consolidating each of these four lawsuits,” Marcus wrote in the opinion. Under Federal Rule of Civil Procedure 42(a), a district court may consolidate multiple actions that ‘involve a common question of law or fact.’”
Moreover, the court noted that a district court’s decision to consolidate cases is discretionary.
The appeals court also ruled the district court was on pit when it denied judgment to Boston Scientific on plaintiff Amal Eghnayem’s claims of failure to warn.
Marcus noted that Eghnayem offered expert testimony that supported her position and warnings didn’t inform doctors that multiple procedures could be required to remove the mesh.
Further, the Florida court didn’t err when it denied judgment to Boston Scientific on its claim that Eghnayem’s claims were time barred.
“It was not unreasonable for the jury to find that Eghnayem’s claims accrued after April 11, 2009 -- the cut-off point for the state’s four-year statute of limitations,” Marcus wrote in the opinion.
“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 in the opinion, affirming the lower court ruling.
https://flarecord.com/stories/511258658-11th-circuit-court-of-appeals-upholds-ruling-against-boston-scientific
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Almost 7,000 women in NI had vaginal mesh implants
Nov 16, 2017 | BBC
By Marie-Louise Connolly
Almost 7,000 women in Northern Ireland have had vaginal mesh implants in the last decade.
The figures released by the Department of Health cover the period from 2005 to 2015.
The number is higher than previous figures, which indicated that the procedure was used in more than 4,000 operations from 2006 to 2016.
A growing number of women are asking for use of the mesh to be suspended.Case studies: Mesh led to 'excruciating pain'Hundreds suing NHS over vaginal implantsWhat's the issue with mesh implants?
BBC News NI has learned that a number of gynaecologists in Northern Ireland have visited their counterparts in England to observe doctors remove the mesh in especially complicated cases.
According to the Health and Social Care Board (HSC), these visits are routine for clinical staff.
In the past six months, the mesh debate has stepped up a gear, with campaigns and lobbying happening in London and Belfast.
With thousands of men and women affected, there have been calls for a public inquiry and for the suspension of the use of mesh devices.
On Wednesday, a Sinn Féin delegation met representatives from the Department of Health.
Sinn Féin MLA Órlaithí Flynn said she was satisfied that the issue was being taken seriously.
"There was a broad range of issues discussed with the permanent secretary, including women having access to full mesh removal in Northern Ireland, as well as having access to 3D scans to assess where the mesh is."
Last month, Kath Sansom, a campaigner for Sling the Mesh in the UK, visited Belfast to meet women who have had the operation.
She said the women "need to be heard and taken seriously".
"The latest studies show at least 10% of women suffer - that is a vastly underestimated figure," she added.
In Scotland, some hospitals have temporarily suspended using the material.
In a statement to the BBC, the HSC Board said it and the Public Health Agency have been working to ensure that women who are experiencing problems with vaginal mesh implants have a clear pathway to treatment.
"In July this year, we advised these women to speak to their GP and ask to be referred back to the trust where the surgery was performed.
"The trusts, in turn, have arrangements in place for these women to be seen promptly by a consultant with an interest in urogynaecology.
"The advice to clinical staff in Northern Ireland is that they should discuss all relevant treatment options with each patient, and agree with each patient, the treatment that is most appropriate for the patient's particular clinical needs."
According to the health board, it is also currently exploring the possibility of establishing a vaginal mesh centre here.
"We plan to maintain close working relationships with a vaginal mesh centre in GB to ensure ongoing quality assurance and development of vaginal mesh services here and offer women the best possible standard of care."
Meanwhile, Susan McLarnon, from south Belfast, said she and others like her, want action.
"We want fixed by experienced surgeons who have done a lot of these operations.
"Ultimately we want the mesh banned," she added.
http://www.bbc.com/news/uk-northern-ireland-42004828
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This once-common surgical material can cause a lifetime of pain
Nov 16, 2017 | SheKnows
Because I watched a lot of daytime TV during certain parts of my life, I remember and sometimes still see commercials for law firms offering to defend folks who had been injured via transvaginal mesh implants. But I was in the dark about what they were or who these ads were directed toward.
Transvaginal mesh implants were a treatment for pelvic organ prolapse, which happens when the pelvic organs can’t be supported by tissue that secures the bladder, rectum and uterus, causing these organs to drop so they’re against the wall of the vagina. This can be caused by childbirth and also by the strength of the pelvic wall muscles eroding with age.
About 300,000 surgeries are performed in the United States each year in order to correct pelvic organ prolapse, and 11 to 19 percent of women who experience issues involving the pelvic floor will need surgery. (Transvaginal mesh has also been used to treat urinary incontinence.) The mesh, made from a porous synthetic material called polypropylene, was cleared for use for these purposes in 2001, is implanted in the vagina to prevent the prolapse (it had been used in abdominal repair surgeries since the 1970s). According to Morgan Statt of ConsumerSafety.org, the mesh was approved by the FDA without clinical data, and 1 in 10 women have experienced complications as a result of the mesh implant.
In 2008, the FDA informed physicians and patients of the risks associated with transvaginal mesh, such as infection, pain during sex, UTIs, the inability to walk, nerve damage, adhesions when tissues grow into the mesh and more, including mental health issues resulting from the stress of coping with ongoing medical problems. Today, the mesh has mostly been pulled from production, and that which remains has been labeled as a high-risk product.
Lindsey Andrews is a lawyer who works with women who have been injured by transvaginal mesh implants.
“The injuries that women are suffering from this mesh implant are severe and debilitating and could have been avoided had people had the proper information,” she said.
Because the mesh is, well, mesh, the edges can cut through the skin and cause infections as well as potentially puncture the bladder, bowel and uterus. Andrews describes the material that makes up the mesh as a “breeding ground” for bacteria. The injuries caused by transvaginal mesh won’t necessarily show up right after surgery; you can be impacted years after the procedure.
“Even after multiple surgeries, doctors are sometimes unable to remove all of the mesh, which by that point has become infused to the surrounding tissue, causing lifelong problems,” reported Andrews.
More: No, Anal Sex Is Not the Solution for This Medical Problem
“These issues can be severe and lead to severe loss of quality of life,” says Michelle Llamas, a senior content writer at Drugwatch who has been writing about transvaginal mesh implants and their effects for many years. “I have spoken to many women that have lost marriages, relationships, careers and their ability to walk without a wheelchair or cane.”
The impact of transvaginal mesh implants has been met with a certain degree of tone-deafness from some medical providers, including some French gynecologists, and marketing professionals, who in emails that surfaced in August 2017 suggested women have anal sex in order to avoid the pain that resulted from vaginal sex due to the implant.
In September of this year, BuzzFeed Australia published a piece examining the impact of transvaginal mesh implants on women in the country after an inquiry looking for those who had been impacted by it revealed hundreds of women in terrible and enduring pain.
“I feel I no longer can have a sexual relationship, which has left me feeling depressed and alone,” said one woman, now 60, who was not made aware of the risks of transvaginal mesh implants when she had the surgery. Throughout the piece, women reported being unaware that over 100,000 women in the U.S. had filed lawsuits due to injuries from the implant. “My life turned to hell [and I suffered] daily pain and discomfort,” another wrote. “Don’t use this product, ever.”
More: Is Squirting Just Peeing? A Doctor Answers Your Most Pressing Pelvic Health Questions
In order to maintain the overall health of one’s pelvic floor, doctors suggest pelvic floor therapy as well as Kegel exercises to strengthen muscles. There are options for treating pelvic organ prolapse without transvaginal mesh. You can learn from your doctor how to insert a pessary, a small plastic or silicone device that can support sagging organs, thereby eliminating the need for surgery altogether. Your own tissue, as well as organic mesh (made from animals), can be used in lieu of the polypropylene that has such devastating and interminable effects.
The bottom line is that if you're diagnosed with pelvic organ prolapse, know you have options that do not involve transvaginal mesh, and don't hesitate to discuss these with your doctor.
http://www.sheknows.com/health-and-wellness/articles/1136976/transvaginal-mesh-implants
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