SURGICAL MESH COMPLICATIONS | INJURED BY SURGICAL MESH, TAKE ACTION!
TRUTH IN MEDICINE HIGHLY RECOMMENDS SYNTHETIC SURGICAL MESH NOT BE USED IN THE FEMALE PELVIS FOR BLADDER SUSPENSION OR PELVIC ORGAN PROLAPSE.
TRUTH IN MEDICINE RECOMMENDS
SYNTHETIC SURGICAL MESH FOR THESE PURPOSES
BE REMOVED FROM THE MARKET IMMEDIATELY!
Please read and try to follow the FDA's tips below....
Give facts and your recommendations for change.
Tell your story but limit emotional comments.
LET'S GET MESH OFF THE MARKET!
Please use the following information to make comments on the FDA's proposal to upclassify Synthetic Mesh used for Pelvic Organ Prolapse from Class II to Class III.
This has been a long process with thousands of adverse events filed by injured women over a period of more than 8 years. All the actions of the FDA have benefited mesh manufacturing companies: Ethicon/Johnson & Johnson, Davol-Bard, American Medical Systems, Boston Scientific, Caldera and Cook Medical, NOT PATIENTS.
Sure the FDA issued warnings in 2008 and 2011, orders for 522 studies Jan 2012 and a proposal to upclassify to Class III and require clinical trials in May 2014. The result of these actions is some of the mesh companies stopped selling their prolapse mesh kits, changed the instructions for use and continue to sell mesh for use in a woman's pelvis.
DESPITE FDA "ACTIONS" THE HORRIFIC HARM CONTINUES.
Written Submissions...Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions:All submissions received must include the Agency name and Docket No. FDA-2014-N-0297 for this rulemaking.
All comments received may be posted without change to http://www.regulations.gov, including any personal information provided.
For additional information on submitting comments, see the "Comments" heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
TIPS FOR SUBMITTING EFFECTIVE COMMENTS*
A comment can express simple support or dissent for a regulatory action. However, a constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision making.
These tips are meant to help the public submit comments that have an impact and help agency policy makers improve federal regulations.
ü Read and understand the regulatory document you are commenting on
ü Feel free to reach out to the agency with questions
ü Be concise but support your claims
ü Base your justification on sound reasoning, scientific evidence, and/or how you will be impacted
ü Address trade-offs and opposing views in your comment
ü There is no minimum or maximum length for an effective comment
ü The comment process is not a vote – one well supported comment is often more influential than a thousand form letters
1. Comment periods close at 11:59 ET on the date comments are due - begin work well before the deadline.
2. Attempt to fully understand each issue; if you have questions or do not understand a part of the regulatory document, you may ask for help from the agency contact listed in the document.
Note: Although the agency contact can answer your questions about the document’s meaning, official comments must be submitted through the comment form.
3. Clearly identify the issues within the regulatory action on which you are commenting. If you are commenting on a particular word, phrase or sentence, provide the page number, column, and paragraph citation from the federal register document.If you chose to comment on the comments of others, identify such comments using their comment ID’s before you respond to them.
4. If a rule raises many issues, do not feel obligated to comment on every one – select those issues that concern you the most, affect you the most, and/or you understand the best.
5. Agencies often ask specific questions or raise issues in rulemaking proposals on subjects where they are actively looking for more information. While they will still accept comments on any part of the proposed regulation, please keep these questions and issues in mind while formulating your comment.
6. Although agencies receive and appreciate all comments, constructive comments (either positive or negative) are the most likely to have an influence.
7. If you disagree with a proposed action, suggest an alternative (including not regulating at all) and include an explanation and/or analysis of how the alternative might meet the same objective or be more effective.
8. The comment process is not a vote. The government is attempting to formulate the best policy, so when crafting a comment it is important that you adequately explain the reasoning behind your position.
9. Identify credentials and experience that may distinguish your comments from others. If you are commenting in an area in which you have relevant personal or professional experience (i.e., scientist, attorney, fisherman, businessman, etc.) say so.
10. Agency reviewers look for sound science and reasoning in the comments they receive. When possible, support your comment with substantive data, facts, and/or expert opinions. You may also provide personal experience in your comment, as may be appropriate. By supporting your arguments well you are more likely to influence the agency decision making.
11. Consider including examples of how the proposed rule would impact you negatively or positively.
12. Comments on the economic effects of rules that include quantitative and qualitative data are especially helpful.
13. Include the pros and cons and trade-offs of your position and explain them. Consider other points of view, and respond to them with facts and sound reasoning.
14. Keep a copy of your comment in a separate file – this practice helps ensure that you will not lose your comment if you have a problem submitting it using the Regulations.gov web form.
Organizations often encourage their members to submit form letters designed to address issues common to their membership. Organizations including industry associations, labor unions, and conservation groups sometimes use form letters to voice their opposition or support of a proposed rule. Many in the public mistakenly believe that their submitted form letter constitutes a “vote” regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence, not a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters.
* Throughout this document, the term “Comment” is used in place of the more technically accurate term “Public Submission” in order to make the recommendations easier to read and understand.
Disclaimer:This document is intended to serve as a guide; it is not intended and should not be considered as legal advice. Please seek counsel from a lawyer if you have legal questions or concerns.
Jane Pennington, Janet Holt, Lana Keeton, Denise Jacobs in Washington, D.C. April 2011 for Congressional Hearing on Medical Devices
Denise Jacobs, Dianne Kelley, Lana Keeton, Kelly Villoch Lead Truth in Medicine Oct 1, 2010 Get the Mesh Out Rally in Washington, D.C.!
Jane Pennington, Sarah McFarland, Wendy Bradley, Janet Holt, Lana Keeton at FDA/CDRH Town Hall Meeting Dallas, TX March 2011
Gynecare TVT Mesh Complications Lana Keeton Dec 23, 2001
Gynecare TVT Mesh Complications - Necrotizing Fasciitis - Lana Keeton Dec 25, 2001
Gynecare TVT Mesh Removal Surgery Pics of Lana Keeton 06-21-2010
Explanted Gynecare TVT Mesh Lana Keeton 06-21-2010 1st Implanted Dec 21, 2001
Here at Truth in Medicine, we are fighting to keep this from happening to other women (and to men for hernia repair). May 2013 will mark the beginning of Year Six for Truth in Medicine's mission to get Synthetic Surgical Mesh off the market, though individual efforts started at the FDA in 2007. Those of us mesh injured patients who are able have been traveling to Washington speaking before Congress, the Institute of Medicine (IOM) and the FDA starting in early 2010.
A milestone came when our testimony from June 2010 was included in the IOM report on the flawed 510 (k) Premarket Notification (PMN) clearance process, which came out in August 2011. Add to that the July 13, 2011 FDA warning of the significant harm from transvaginal mesh for pelvic organ prolapse, and the floodgates of awareness of this medical disaster opened up. As a result, synthetic surgical mesh has become the "poster child" for bad medical devices on Capitol Hill.
We won some battles but this is not over. The fight continues. Still, hundreds of thousands of patients have mesh implanted every year for hernia repair, bladder suspension and pelvic organ prolapse, leading to horrific complications and a lifetime of pain and suffering. Despite the warnings, thousands of lawsuits and mandated 522 studies by the FDA people continue to be harmed every day.
We have to step up our efforts as patients educating patients! Please participate. Please take action. Please join our cause! We need your support, your donations and most of all, action on your part.
Tell everyone you know not to listen to claims “Minimally Invasive, Outpatient Procedure”. “Oh, it’s a new mesh and it’s better.” Please tell everyone you know the truth about mesh and the harm it causes. Don't let someone you know, someone you love be harmed!
ALL MESHES are capable of causing significant harm and even death. They shrink, they harden and they move within the body AFTER they are permanently surgically implanted. Having them surgically removed when they cause complications is like removing gum from hair.
The doctor has to surgically cut and remove your own tissue to get the mesh out. And most doctors who implant meshes do not have the surgical skills to remove them. Or how to locate them in your body with an MRI or CT Scan or Ultrasound.
Life altering catastrophic complications happen every day to patients from the surgical implantation of Synthetic Surgical Mesh for hernia repair, pelvic organ prolapse and bladder suspension, both male and female.
When this happens, doctors frequently have no idea how to deal with the complications. Or to avoid liability, they deny mesh is the root of the complications and/or frequently blame the patient.
Are you one of these patients? Has your doctor abandoned you? Do you need medical attention or just someone who believes you? We believe you. We will try to help you find the right medical treatment.
Truth in Medicine is fighting the sale of mesh by greed driven pharmaceutical companies and medical device manufacturers. Truth in Medicine is focused on making changes to the 510(k) Premarket Notification “clearance” process at the FDA to better protect patients! Truth in Medicine has a presence in Washington and is determined to stop the atrocity of mesh implantation.
Many “outpatient procedures” are life threatening! Are they worth risking your life? Do you really need surgery? Is your doctor implanting a medical device? Is your doctor really telling you everything he or she knows?
If it sounds too good to be true, it probably is. There are no magic buttons. Doctors do not heal you. Doctors only have the ability to help your body heal itself.
If you already have mesh implanted, you can not change what happened to you. You can prevent it from happening to other people!! Your participation in our cause will make a difference! Please make a difference! Please register on the Worldwide Registry of Complications of Synthetic Surgical Mesh so we will be able to show the FDA and its’ CDRH the true number of people harmed by mesh!
REMEMBER…if you need surgery and do not have Synthetic Surgical Mesh already implanted in you, ask your doctor to repair your hernia, improve your incontinence symptoms or treat pelvic organ prolapse with an alternative procedure! If they don’t know an alternative procedure, find another doctor who does. You will be saving yourself lifelong heartache and pain.
We really need you to help us to help others. Please donate to support our cause!