Restorative Justice Proposal for Transvaginal Mesh Harmed Women

Restorative Justice Proposal for Transvaginal Mesh Harmed Women

Proposed by Mesh Harmed Women

May 29th 2015

Nonie Wideman

Advocate for Mesh Harmed Women

PO Box 134, Rose Prairie BC, Canada, V0C2H0

Judge Joseph Goodwin

Charleston, WV federal courthouse

Honorable Joseph R. Goodwin, Judge

P.O. Box 2546

Charleston, WV 25329-2546

7009 Robert C. Byrd

United States Courthouse

300 Virginia Street E.

Charleston, WV 25301

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?

Prolene mesh

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 McClain

• I 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 FDA

• I 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-416625

• http://ireport.cnn.com/docs/DOC-422675

• I 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 9/2010
• Leadership America Board Member
• FAILED 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.

Mrs. Aaron Horton/The Mesh Warrior Founder, The Mesh Warrior Foundation for the injured

• W: tmwfoundation.org
• B: themeshwarrior.com
• T: @TheMeshWarrior
• F:https://www.facebook.com/themeshwarrior

Dora De Wilde

• A 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 Belgium
• andmeshedup.eu Maria Smit Netherlands

Europe women are watching how those horrible operations will be stopped, we all hope that you can make the difference!

Nonie Wideman

• Administrator, 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 members
• Website creator of meshproblems.weebly.com, over 5000 visits to peer reviewed information website
• member of MAM, (Mesh Awareness Movement)
• member of and contributing research writer to Mesh Medical Device News Desk https://www.facebook.com/groups/142368339207055/?ref=bookmarks
• Author of The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseasesby Nonie Wideman, April 2013 ,http://meshproblems.weebly.com/linking-the-research-from-fbr-to-implant-materials-to-autoimmune-disease-initiation-or-exacerbation.html
• And 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