Preview Newsletter
Ethicon 6/16
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Judge sets 26 Ethicon mesh cases for a single trial
Jun 15, 2015 | Reuters
By Jessica Dye
A federal judge overseeing thousands of transvaginal mesh lawsuits has set a single consolidated trial for 26 women who said they were injured by a device made by Johnson & Johnson's Ethicon Inc unit. -
Mum joins campaign to ban medical procedure
Jun 15, 2015 | Sussex Express
A Heathfield woman is backing a national campaign to ban a medical procedure in the UK after suffering serious complications from the operation. -
New robotic system to help with Pelvic Prolapse
Jun 15, 2015 | KGNS (NBC)
By Justin J. Reyes
Whether it's having a baby, aging, undergoing a hysterectomy or gaining weight, many women will develop a condition where their pelvic floor organs begin to fall or prolapse. -
*New* Restorative Justice Proposal for Transvaginal Mesh Harmed Women
Jun 15, 2015 | Mesh Medial Device News Desk
By Jane Akre
Transvaginal Mesh harmed women have been supporting each other through horrendous injuries, and tortuous surgeries to remove defective mesh products from their bodies for years.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Judge sets 26 Ethicon mesh cases for a single trial
Jun 15, 2015 | Reuters
By Jessica Dye
A federal judge overseeing thousands of transvaginal mesh lawsuits has set a single consolidated trial for 26 women who said they were injured by a device made by Johnson & Johnson's Ethicon Inc unit.
On Friday, U.S. District Judge Joseph Goodwin in the Southern District of West Virginia set a November 2 trial date for the cases, which are among more than 25,000 consolidated in multidistrict litigation against Ethicon over its mesh products.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/1ToSYjS
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Mum joins campaign to ban medical procedure
Jun 15, 2015 | Sussex Express
A Heathfield woman is backing a national campaign to ban a medical procedure in the UK after suffering serious complications from the operation.
Claire Cooper underwent the TVT mesh sling operation in November 2008 after four years of suffering bad stress incontinence.
Three years after her operation, the mother-of-two had another operation that used high heat close to her sling and since then, she has been the victim of a catastrophic chain of events leading to lifelong, life-altering pain.
The 40-year-old said: “Initially, I had a few minor side effects from the sling but other than those, I was very pleased.
“Around this same time, I was also being treated for heavy periods and in 2011, it was suggested I had a thermal Endometrial Ablation using the balloon and boiling water method, which took place in November 2011.
“A day later, my nightmare began. I have never experienced tearing, sickening pain like it. Weeks went by, and then months, and despite procedure after procedure and subsequent time off from work, I was no better.
“I had a hysterectomy on January 24, 2013 and it was a total abdominal type, taking my cervix too. After a few weeks post op, it was clear I was in more pain than ever and I became desperate.
“I left employment in January 2014. I felt my life was over.
“I heard a feature on the TVT implants and the main speaker was Dr Sohier Elneil, a consultant urogynecologist. I contacted Dr Elneil and she agreed to see me. Very quickly, she diagnosed a very damaged sling and explained why.
“Because they are made of polypropylene plastic, they shrink with heat.
“And of course, I’d had the high-heat thermal ablation very close to it.
“On May 19, I was admitted for partial removal surgery. It was found that the mesh had indeed shrunk to a stiff cheese wire and sliced through muscle, nerves and tissues before embedding itself.
“I then embarked on a series of degrading tests to see what was working and what wasn’t, and then wait for my tissue to heal enough to have repair surgery. I am now recovering from that surgery but my agony remains the same. I am maimed, pained and am half the women I once was.”
Claire is now backing a national campaign called Sling the Mesh to have the procedure stopped in England and Wales, as it was in Scotland last year.
The campaign also wants the risks to be fully explained to patients and a national register to be launched to track all future problems.
Visit https://slingthemesh.wordpress.com for details.
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New robotic system to help with Pelvic Prolapse
Jun 15, 2015 | KGNS (NBC)
By Justin J. Reyes
Whether it's having a baby, aging, undergoing a hysterectomy or gaining weight, many women will develop a condition where their pelvic floor organs begin to fall or prolapse.
Left untreated, you could develop a host of medical complications.
The only way to fully restore function is through a prolapse surgery, something that now can be done with the Da Vinci robotic surgical system through six tiny incisions, versus one large cut.
"When we go into the abdomen and into the pelvis, we dissect the vagina free from the bladder and from the rectum. When you're separated those two fascial layers, you're able to position the mesh in between those two layers, sandwiching the vagina and lifting it up", said Dr. Kenneth Ewane.
The Da Vinci system features a magnified 3D HD vision system and allows the doctor to operate with enhanced vision, precision and control leading to a better recovery compared to a traditional open surgery.
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*New* Restorative Justice Proposal for Transvaginal Mesh Harmed Women
Jun 15, 2015 | Mesh Medial Device News Desk
By Jane Akre
Dear Judge Goodwin,
Transvaginal Mesh harmed women have been supporting each other through horrendous injuries, and tortuous surgeries to remove defective mesh products from their bodies for years. We have been supporting each other through social media sites. We have watched the mesh lawsuits wondering how justice would be served best for the thousands upon thousands of women worldwide, realizing the mesh products in their bodies are causing life altering and life threatening injuries.We are dismayed when punitive awards get appealed and held up in constant battles.We are dismayed when settlement offers do not cover the cost of full mesh removal surgeries, or adequately compensate for the damages to our bodies that we will likely sustain for the rest of our lives.We are dismayed when women do not have choices to go to mesh removal specialists because the best doctors to remove mesh are not in some health insurance providers’ network.We are dismayed when settlement amounts are for the most part linked to the number of surgeries a woman has had.
This dismay comes from researching outcomes of other women who have endured multiple partial mesh removals. Our consensus among a group of nearly one thousand women is that partial mesh removals are linked to more complications and unsatisfactory resolution of mesh complications. Women are waiting in painful situations for access to qualified full mesh removal surgeons to have all or as much mesh as possible removed in one surgery. There are no studies available to say that partial mesh removals are of more benefit than aggressive mesh removal when mesh is degrading, eroding and extruding, and causing systemic havoc in the process. There is however, one full mesh removal surgeon from UCLA, who has definitively stated to at least one mesh injured woman that partial removals are the worst thing a woman can do. He further stated that once the mesh is cut, it begins to leach toxins into the body, and that it also begins to crumble. This doctor stated that when mesh begins to crumble, it is then like looking for shrapnel in the human body. When asked whether the toxins would filter out of the body after seven years, the time it takes for our blood to completely filter itself, his response was no, the toxins invade our organs and do not stay in the bloodstream.
It is not fair to equate the number of surgeries with the amount of compensation.
Women are afraid to have partial removals, afraid it will make it harder to remove all or as much mesh as possible, have opted not to have multiple surgeries. Women waiting to get to qualified surgeons suffer just as much or more than those enduring multiple surgeries. We realize multiple surgeries are sometimes indicative of a higher level of injury, and this needs to be considered. However recognize that not all women with mesh complications are able to get degraded mesh removed in a timely manner because of financial situations and lack of access to mesh complication experts. We suspect the more surgeries we have, the more nerve damage we may incur. Nerve damage often causes irreversible chronic pain.
May we respectfully suggest that in conjunction with punitive awards that get scooped up by states under tort reform, a restorative justice plan be put into place?
Instead of large fines for punitive damages, sometimes numbering in the millions, why not allow manufacturers a face-saving way to avoid paying the large punitive measures by agreeing to fund a non-profit foundation, established and maintained by mesh injured women, with representation from several countries, with at least 50-75% of the suggested punitive award being used for mesh removal surgeries and travel expenses for the mesh injured woman and one care taker, and reimbursing those that have already had their mesh removal surgeries for all out of pocket and travel expenses? Women should be able to choose their surgeons based on research rather than the ones insurance providers allow. We are working to set up a foundation to help women with mesh excision surgeries and reconstruction surgeries post mesh removal.
This would be RESTORATIVE justice. Restoring women’s lives, by providing free mesh removal surgeries, by providing free access to chronic pain management centers of excellence, and free access to autoimmune specialists who recognize the understudied systemic responses of chronic inflammation caused by mesh complications. We want restorative justice, as well as compensation.
Where there is a will, there is a way. Many women might consider forgoing large compensation awards if they could have free access to centers of excellence to treat and manage mesh complications caused directly by POP mesh and SUI mesh products. Give them choices. Surely a group of intelligent lawyers with mesh injured women’s best interests at heart, under the guidance of a wise judge, can come up with a restorative justice plan proposal that is fair to women, and fair to the lawyers who have incurred costs providing representation to injured women. Brilliant minds will be gathered June 2nd. Please listen to our proposal. It would take very little effort for your legal teams to register a no profit foundation for the hundreds of thousands of mesh implanted women.
Scales of Justice
We want it named Women’s International Pelvic Mesh Removal Foundation. If mesh manufacturers could pay for restorative mesh removal surgeries and treatments, pay for studies into the systemic effects of mesh complications rather than pay punitive damages, perhaps victims of mesh complications would feel justice is being served. It would be better served by involving mesh harmed patients heartfelt advice and opinions, unvarnished by legal jargon, into the restorative justice plan proposal.
Please hear us. Please respond. Justice delayed is justice denied. Denied access to highly skilled doctors for any reason allows mesh complications to cascade and threaten life and quality of life.
Sincerely from mesh harmed women worldwide.
Advocates, and mesh support leaders for mesh injured women in support of this letter are as follows:
Suzanne McClainI have been instrumental in educating victims of surgical mesh on how to obtain their medical records, and how to find the type of mesh implanted in them; I have advised mesh injured women how to file adverse events with the FDA since 2008; and I’ve assisted these women with finding doctors who are proficient in full mesh removal.I have educated women on the Statute of Limitations for Personal Injury and Medical Malpractice in their respective states, and made recommendations regarding legal counsel.I have performed years of research on surgical mesh, and penned many articles and letters about what damage can be done to the human body by polypropylene.Mesh complication researcher/ specialty: history of mesh clearances by the FDAI have tied over 60 surgical mesh devices cleared by the FDA under the 510K clearance program, (meaning no clinical trials were required) straight back to The ProteGen Sling. The ProteGen Sling was voluntarily removed from the market via letter from Boston Scientific to the FDA on January 22, 1999; the FDA formally removed the product from the market nearly two months later, on March 17, 1999. My articles, covering approximately 35 of these devices can be found on CNN iReport at:http://ireport.cnn.com/docs/DOC-416625http://ireport.cnn.com/docs/DOC-422675I am a mesh injured woman who has endured several mesh related surgeries; one to implant; three for removal; one for autologous (native tissue) repair. I have suffered excruciating pain as a result of mesh erosion, and work toward total removal of transvaginal mesh from the market. I was uninformed of the danger; my goal is to make sure not one woman whose doctor recommends transvaginal mesh goes into this with their eyes closed. The women who have already been down this path need a voice. They need medical care, and they need justice.
Joleen Chambers
Joleen would like to add; “I would personally extract from the manufacturers a full admission of product/material defect. Settlements should not be paired with any required confidentiality clause because harmed women have lost enough without being forced to stay quiet about PREVENTABLE harm and delayed and minimal justice.”FDA/CDRH-trained Patient Representative 9/2010Leadership America Board MemberFAILED implant Device Alliance (FiDA) founder
JjrkCh Twitter, http://fida-advocate.blogspot.com
Danyelle Robinson, Co-administrator of Medical Mesh – Outreach and Activism
Dear Judge Goodwin,
I just want to add that taxpayers are forced to pay for the lifelong care needed by many woman and men following implantation and removal of medical devices. Manufacturers make billions of dollars, yet pay pennies for problems they knew existed. Additionally what may be acceptable risks for life-saving surgeries can be excessive in relation to elective and cosmetic surgeries. Medical Implant patients are fast becoming a public health care crises as it looks like we are the epicenter of superbugs. Hold manufacturers accountable.
Lorraine Evans,
Dear Nonie, We support your letter to Judge Goodwin.
With Love and Healing Light to all the Mesh Injured Worldwide
Founder:The Voices Today on Messed up Mesh (TVT Mum)Website: http://www.tvt-messed-up-mesh.org.uk/NHS England Patient and Public Voice (PPV) RepresentativeWebpage: http://www.tvt-messed-up-mesh.org.uk/NHS-England-Patient-Public-Voice-Members.htmlvoice for 500+ mesh injured women in the United Kingdom
Mrs. Aaron Horton/The Mesh Warrior Founder, The Mesh Warrior Foundation for the injuredW: tmwfoundation.orgB: themeshwarrior.comT: @TheMeshWarriorF:https://www.facebook.com/themeshwarrior
Dora De WildeA voice for hundreds of women who are hurt by the pelvic meshes.Together with the Netherlands we represent more than 600 women.meshedup.eu dora De Wilde Belgiumandmeshedup.eu Maria Smit Netherlands
Europe women are watching how those horrible operations will be stopped, we all hope that you can make the difference!
Janet L. BeyerAdministrator for Mesh Problems open Facebook group (membership 925) and Women’s POP/SUI TvMesh Complications Support closed Facebook group (membership 475.)I would like to say that: “As the medical expenses, pain & suffering, lost wages, and future medical needs of mesh-injured women are considered, please also consider the losses that our spouses and families have experienced because of transvaginal mesh implants. Many of us were disabled at a very young age by a transvaginal mesh implant, thus are facing numerous years of lost income due to the severe damage these devices have caused. I was a healthy 40 year old woman, but because of the mesh implant’s damage to my body, will likely never be able to work again. That means 25+ years of lost income for my family. Also, we cannot forget the very important “Loss of Consortium” claim that our spouses/partners are justified in making. For most of us, sexual contact or stimulation of any kind causes such a drastic increase in pelvic pain that we forego any kind of sexual contact completely. Please consider the fact that those of us injured by mesh, as well as our spouses/partners, have permanently lost our sex lives. For many spouses, this is a devastating loss.”
Linda Patterson For Women’s POP/SUI TvMesh Complications Support closed Facebook group
Nonie WidemanAdministrator, advocate for Links on Mesh,social media group providing mesh research and support contacts for mesh harmed women, membership 900+Member of and contributor to , Women’s POP /SUI TV Mesh Complication Support, 466 membersWebsite creator of meshproblems.weebly.com, over 5000 visits to peer reviewed information websitemember of MAM, (Mesh Awareness Movement)member of and contributing research writer to Mesh Medical Device News Deskhttps://www.facebook.com/groups/142368339207055/?ref=bookmarksAuthor of The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases
by Nonie Wideman, April 2013 ,http://meshproblems.weebly.com/linking-the-research-from-fbr-to-implant-materials-to-autoimmune-disease-initiation-or-exacerbation.htmlAnd last but not least, a mesh injured patient with personal experience of the trauma of cascading mesh injury, advocating for improved access to skilled health care providers for mesh injured women.Sincerely, Ms.Nonie Wideman
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