The FDA & Injured Women
When I read the latest FDA report in February this year 2016, all I could think of was “They know what this is doing the women and yet they allow this to continue every day, which will result in more women who will live like me”. I felt elated when I read it because I had written about many of these things in the past and yet I felt dam angry that the panel of doctors on the FDA board are taking the usual stand. Put out a report, but let the devastation and injury of women continue.
I am now going to share with you some of what the panel said about the techniques of this surgery and the tools (trocars) used. I am well aware that others have written about the reclassification of these tools, but they have not lived with the consequences of the damage caused by these tools. I have and I still am.
Before I share part of this report, I want women to know that for six years I have sympathized with injured women and I still do. However, there are times when I feel so frustrated because other women do not always do their part against the War on Mesh. We can only win this war if more women let other women know what mesh has done to them and how it impacted their lives.
Here is part of the FDA report which is 40 pages long plus attachments, dated February 26th 2016.
- Designed, packaged, and indicated for use with one specific urogynecologic surgical mesh device. The packaged combination of mesh and instrumentation is referred to as a urogynecologic surgical mesh kit.
Kits began to be produced in the early 2000’s and before anyone knew it, they became abundant and in every operating room and accepted as the ‘Gold standard of treatment’. It became acceptable practice to place a mesh sling in every woman who underwent a gynecological procedure, hysterectomy, prolapse and other procedure to do with women’s bodies. Kits are cheap to produce and can be sold at a high price in every hospital across this country and around the world. Because they could make a lot of money, it was not long before many manufacturers joined in. The results have been devastating to women.
2. Designed and indicated for use with multiple urogynecologic surgical mesh devices. The instrumentation is packaged and marketed separately from the mesh devices.
3. Designed and indicated for use with a urogynecologic surgical mesh device but also indicated for non-mesh urogynecologic procedures, e.g., pelvic floor repair procedures
Please note that the FDA is not proposing to reclassify general instrumentation used during urogynecologic surgical mesh procedures. The FDA is only proposing to reclassify urogynecologic surgical mesh instrumentation that is designed to be used with urogynecologic surgical mesh. General instrumentation will remain in class I. III. Regulatory History Section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C Act; 21 U.S.C.360c) establishes three categories (classes) of devices based on the risks to health posed by the devices and the regulatory controls needed to provide reasonable assurance of their safety and effectiveness.
From day one of my own prolapse surgery where a mesh kit was also used, I had so many health issues I was shocked. I was a very healthy person who never had illnesses or any surgeries before that first one in March 2010. From that moment on I experienced horrendous pain and suffering and that has not changed since. Since that first surgery, I underwent four more surgeries to fix problems, remove the mesh and then try to fix my injured body. Five terrible surgeries where I had so many problems and had to self-cath. Not only does this hurt your body but it hurts your mind.
When I learned what had been used in my body I was dedicated to learning more about it and what had happened to me, but finding information on the Internet six years ago was almost non-existent. I searched and searched and when I found even traces of what I was dealing with, I presented them to my implanting doctor. It was a mine field of battles and wars that I refused to give up on, even though I was never believed. She did not believe me because the manufacturer had sold the kit to the hospital where she did surgery and therefore, in her mind it had to be good.
Class I devices are low risk and require less regulatory control whereas class III devices are high risk and require the most regulatory control. Class II devices are intermediate with respect to both risk and regulatory control. Please see Attachment 2 for an overview of the risk based classification and regulation of medical devices. Urogynecologic surgical mesh indicated for transvaginal POP repair are class III devices, and urogynecologic surgical mesh for all other indications (i.e., transabdominal POP repair and female stress urinary incontinence) are class II devices. Urogynecologic surgical mesh instrumentation is regulated as a class I device under 21 CFR 876.4730 (manual gastroenterology-urology surgical instrument and 3 accessories) and 21 CFR 878.4800 (manual surgical instrument for general use). Urogynecologic surgical mesh instrumentation is exempt from premarket notification procedures; and therefore, their design, biocompatibility, sterilization method, etc. are not reviewed by the FDA prior to being marketed.
However, when instrumentation is packaged with the surgical mesh in an urogynecologic surgical mesh kit, the FDA has reviewed the instrumentation as part of the premarket notification (510(k)) submitted for the urogynecologic surgical mesh.
Ladies if YOU have NOT as yet reported your complications to the FDA, then you should be aware that we are all still in a War against the use of mesh and the technique which is used to put into our bodies. Thank you to all the women who DID report their complications to the FDA and there is a chart on page 6 of this report to show you the rise in complications over the years from 2008 to 2015. I would have loved to have copied it to show you the rise in 2015, but it would not allow me to so please look at it for yourself. This is SO IMPORTANT because women have now been implanted by the hundreds of thousands by this time and the reports will grow alarmingly over the next several years and it is up to us, the already injured women to do all we can to change this.
This report only covers the tools used in these kits, but we know the long term complications of the mesh itself can be terrible.
When I feel like giving up on this War, I ask myself, how many women will die a long slow death from all their complications? How many women will die who never even knew it was a badly designed implant that caused their death? I believe there are many because as yet, mesh complications are the last thing that is blamed for a woman’s death. So I go back to working to finding a way to win this War instead of giving up.
Ladies it is not hard to report to the FDA and you can do it over the phone. If you sit on the side line thinking to yourself “I don’t need to do this because all the other women already did it”, then you will be part of the problem and not part of the solution.
If you can file with a lawyer, you can file with the FDA! All you need is the make and number of the implant and a LIST of your complications!
You cannot file with a lawsuit without these same things, so if you haven’t reported as yet and have filed suit with a lawyer, then why have YOU not reported what happened to you, with the FDA? Please, please help win this battle against the War on Mesh.
The reason it has taken so long for the FDA to take notice of the problems associated with the mesh kits, is because not enough women report their complications direct to the agency and not enough doctors are working with us to share their knowledge of mesh complications. I do thank God that some have taken that stand and have written about adverse reactions, but we need more to help stop the carnage of injured women.
I am not going to be popular when I write this, but I have taken note over these past six and a half years how women love the idea of joining up to rally in front of a court house or Mesh Manufacturer’s annual meeting and yet THE MOST IMPORTANT thing they can do to change what is happening to women because of these implants, they sometimes do not do. If they themselves would list EVERY complication they are dealing with after a mesh implant and report them to the FDA, things just may change far sooner. Or if they would only help a woman who is struggling and can’t report her complications, that could also help win this War.
I have never given up on the War on Mesh because I am truly disabled by the implant. I continue to battle to win this war, not for me but for the future generations of women who could wind up just like me. If I can help it, IT WILL NOT HAPPEN.
If you truly want to do something to change this and you are not disabled like me, then all you have to do is sign up with your local hospital urology or other female departments to receive emails and you will find out when they will hold a meeting and invite women to learn how they can be fixed if they have any female issues. They are still putting mesh in women every day and are battling against the FDA report by going direct to the source. You can take some printed pamphlets (write-up already done for you free if you click at the top of this blog) and leave some in the women’s rest rooms or hand them out in person. Tell your story. Warn other women so that they don’t have to go through any of this. Then you truly will make a difference.
Just remember this the next time you say “Why do they keep doing this to women?” If you are not part of the solution, then you are part of the problem.
Every American woman who reports their complications to the FDA can and will be part of the change for the women of the future all over the WORLD, including their own daughters, granddaughters and down on the line of those who will come after they are gone.
Also think about this. When you pray to God to help you with this situation, then you must respect the fact that God cannot change this without the very people who are already injured. HE needs your help!
Now to continue with this report. Much of this report is the same old rhetoric and I realize it is boring, but without it, you won’t get the full gist of it.
The FDA is proposing to reclassify urogynecologic surgical mesh instrumentation into class II so that all new instrumentation will be subject to premarket notification (510(k)) requirements and special controls. Section 513(e) (1) of the FD&C Act sets forth the process for issuing a final reclassification order.
Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) publication of a proposed order in the Federal Register;(2)
consideration of comments to a public docket; and (3) meeting of a device classification panel described in section 513(b) of the FD&C Act.
Remember the FDA panel is reluctant to state the obvious. But I will. Mesh complications shorten women’s lives and cause many illnesses that are often irreversible. The FDA has put out this report and yet they refuse to halt all these surgeries until the problems are fixed and remove all the mesh kits from the shelves of hospitals WORLDWIDE until the manufacturers recognize that mesh complications are real and highly damaging to women’s bodies. As you can see they took the first step on May 1st 2014 and yet more than three years later, many more women have been injured and sometimes debilitated for life.
The FDA completed the first step on May 1, 2014, by publishing a proposed order titled “Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation. “In this proposed order, the FDA proposed to reclassify (1) surgical mesh indicated for transvaginal POP repair from class II to class III and (2) urogynecologic surgical mesh instrumentation from class I to class II. The FDA also proposed to develop new regulations for these devices under Part 884, Obstetrical and Gynecological Devices.
You should also know that there was a small number of women (just over 200) who did realize that mesh implants had caused their descent into hell and they filed lawsuits back in 2004, only a couple of years after the first kits had begun to be used. However, it did not stop even MORE manufacturers from bringing out these kits and push them forward to willing doctors who wanted to get in on a new wave of money making surgeries.
The FDA received public comments regarding the urogynecologic surgical mesh instrumentation reclassification as part of the May 1, 2014, 513(e) proposed order, satisfying the second step of the reclassification process. The FDA will complete the third step of the reclassification process by convening the Panel on February 26, 2016. [Please note that the Obstetrics and Gynecology Medical Devices Advisory Committee Panel discussed the proposed reclassification of surgical mesh indicated for transvaginal POP repair on September 8, 2011. The FDA reclassified surgical mesh indicated for transvaginal POP repair to class III in a final order dated January 5, 2016.] Almost three years later, because there are not enough American women who report their complications to this panel.
So what did the manufacturers have to say about the reports of tool malfunctions? Here it is.
16 For those reports where the device was not returned or the manufacturers stated they were unable to confirm the complaint, the reports did not include information which aided in the analysis as to the cause of the reported problems.
For 39 of the 92 reports which listed that the device evaluation was still in progress at the time of initial MDR submission, supplemental reports were later submitted with an analysis result. The manufacturers’ responses in such cases included:
•”the most probable root cause classification is operational context”
•”the complaint is associated with a product that meets the design and manufacturing specification but due to anatomical/procedural factors encountered during the procedure, performance was limited”
•”a root cause classification of handling damage indicates the complaint was caused by handling of the device or portion of the device without direct patient contact”
•”the device history record review found the device met all manufacturing specifications”
•Re-stating the device’s Instructions for Use with warnings and contraindications address the proper use of the device, and possibly problems that may be encountered if not adhered to.
One supplement report for an Uphold Lite device manufactured by Boston Scientific Corporation stated that a possible supplier manufacturing issue of improper crimping of the suture may be related to the reported event of the suture detaching from the needle. The supplier has completed an investigation to address this issue. Additionally, a review of the device history was performed with no anomalies noted.
The manufacturing conclusion, “device failure occurred and was related to event”, was provided in MDRs following a visual analysis of returned product and confirmed the original complaint such as: “tip of used needle was found bent and broken”, “tip of needle was damaged”, “tip of trocar sheath broke”,
and “sheath around mesh was broken.” Additionally “batch met all finished goods release criteria” was also provided in a number of the supplemental reports as a manufacturing conclusion statement.
The MDR listing “device was out of specification in a manner that relates to event” as a conclusion involved a bent needle tip from a Tension Free Vaginal Tape device manufactured by Ethicon, Inc. The manufacturer additionally stated that the “batch met all finished goods release criteria.”
The MDR which listed “design deficiency” as a conclusion involved an Uphold Lite device manufactured by Boston Scientific Corporation. The manufacturer stated that the most probable root cause for the event of “Capio device would deploy at a slight angle” was “design.” Further analysis for needle detachment could not be determined. Additionally, the manufacturer stated that the device history record review found that the device met all manufacturing specifications.
The MDR which listed “manufacturing deficiency” as a conclusion involved a needle detachment from a Boston Scientific Corporation Uphold Lite device. It was further stated in the report that the conclusion was not yet available as the evaluation was still in progress.
IV. Summary of Clinical Evidence
Adverse events related to an urogynecologic surgical mesh procedure, and that might be attributable to the instrumentation used in the procedure, are typically submitted or described with reference to the surgical mesh and not the instrumentation. Therefore, it can be difficult to distinguish adverse events related to the urogynecologic surgical mesh instrumentation from those directly related to the surgical mesh.
The panel then states the obvious things that can happen during these surgeries, because there is no way to dispute certain things that can go wrong.
The FDA believes that intra-operative and peri-operative adverse events, such as organ injury and perforation, hemorrhage and bleeding, and nerve injury and paincan be reasonably attributed to the urogynecologic surgical mesh instrumentation and not the surgical mesh. The FDA believes it is unlikely the surgical mesh itself caused those adverse events.
Once again THE most important thing women can do is report their LONG TERM complications which did not happen immediately but did happen over the YEARS.
Although the previously described adverse events are inherent to urogynecologic surgical mesh procedures, the FDA believes they can be mitigated through well designed instrumentation and appropriate labeling.
This is what upsets me so much. They state that the instruments need redesigning in that paragraph and yet thousands of kits still sit on operating room shelves to be used on many, many unsuspecting women without proper warning to the WOMEN themselves. It is the women who need warning, not just the doctors.
One woman told me that when she went to her doctor, he told her he would do her surgery, but she should go home and ‘Google’ mesh. What the hell is that? All he had to do was provide her with a proper pamphlet for her to read. I too was never given a pamphlet or told anything, so very little has changed in six and a half years. That is why it is up to us to do something.
In addition, the use of urogynecologic surgical mesh instrumentation may lead to adverse tissue reaction as a result of using non-biocompatible materials. There it is. NON-BIOCOMPATABLE MATERIALS. Unless surgeons go back to learning how to fix women using their own tissues, more will die a slow and horrible death. It may also lead to infection due to inadequate sterilization, inadequate reprocessing procedures, or use beyond the labeled expiration date. This is why once a mesh implant has been placed in a woman’s body, many women will suffer serious side effects and infections for the rest of their lives and the antibiotics will no longer work. That means an earlier death for many unsuspecting women.
The FDA panel sits on the sidelines trying to get along with all the doctors who are pro-mesh. These big organizations are fighting hard to keep these kits on the market, so we all have to fight harder to change this.
These are general risks that apply to devices that have patient contact, are provided sterile, and are reusable; and therefore, it is challenging to identify adverse events in the MDR database and published literature specifically related to those risks. It is challenging to identify because doctors refuse to report the things that happen to women, not only during surgery but years after and there is no way to force them to.
There is a lot more with many charts on this report and I will give you the link at the bottom of this blog for you to read to the fullest extent. This next paragraph I wanted to include in this blog. It will tell you about some of the malfunctions that happen with these tools and few doctors report them.
How many of us were under anesthesia when one of the needles broke in the hands of our surgeons? How would we know. I doubt if there is any surgeon who would put that in our operative reports, in fact most operative reports are vague to say the least.
MDRs related to broken suture MDRs Related to Cover Sheath and Needle Passer Insertion Tool Covering sheath and needle passer/insertion tool (often referred to as a trocar) issues including break, detachment, retained, bent tip, and other miscellaneous problems were listed in 70 of the 463 MDRs (15
injury and 55 malfunction reports). The primary manufacturer which listed these issues was Ethicon, Inc. with 55 MDRs. The primary device issue noted was the break or tearing of the covering sheath during placement of the device. All but three of the MDRs noted that the procedure was completed either with
the same or second device.
This is how I feel. Doctors are not recognizing the complications from these implants and tools, when women tell them while in their offices. Women are either refused to be believed, or are ushered out of their doctor’s office and made feel highly uncomfortable, in the hopes they will never return again. Believe me most won’t because they are so distraught or angry. Or they succumb to the hand out of prescriptions for depression or pain.
So why would any doctor believe a woman if she states that she feels something happened during surgery. This is why I am including the next paragraph.
Where noted, patient outcomes were reported as “with no adverse patient consequence.” Of the device issues which noted a retained covering sheath, it was reported that a portion was left in two patients, another patient needed further dissection to remove the broken portion, and the fourth patient required a laparoscopic procedure for removal of the retained sheath. The miscellaneous needle passer/insertion tool issues noted included the connector/tubing between the needle passer and mesh breaking off, cracking of the tubing that is connected to the needle passer/insertion tool and mesh, difficulty experienced by the physician to maneuver the needle passer/insertion tool, and wire noted protruding through the needle passer/insertion tool upon
In this report there are many charts to read about specific things that have happened with these tools while women are having surgery. But I am sure not one doctor after the surgery was over, informed the woman herself, that this happened. How would the FDA know that there were ‘no adverse patient consequences’ if the woman never knew something happened, and is not believed when she returns to the doctor’s office?
Based on the information provided in the MDR database, the FDA draws the following conclusions:
•Boston Scientific Corporation (n=316) and Ethicon Inc. (n=90) were the two manufacturers which had the highest number of MDRs.
•The top reported instrumentation problems were issues noted with the suture and needle detaching or breaking. These two device issues were seen predominantly with Boston Scientific Corporation’s two products, the Pinnacle and Uphold Systems.
•Other instrumentation problems included issues with the covering sheath either tearing or “breaking” during device placement, primarily noted with Ethicon, Inc.’s Gynecare TVT System, and the Capio/Needle holder failing to capture or pass the needle during mesh insertion (all but one seen with Boston Scientific Corporation’s Uphold and Pinnacle Systems).
•Additional instrumentation issues included anchor breaks noted with the AjustSling System manufactured by C.R. Bard, Inc., introducer/dilator breaks and “kinking/bunching,” as well as deployment of various mesh components.
•”Device fragments in patient” can be clinically significant in that device fragments left inside a
patient may not be retrieved or found, possibly leading to a need for later surgical retrieval if the fragment(s) lead to patient problems. Even when identified and retrieved during the initial mesh implant procedure, there is typically an increase in overall surgical time.
•The devices were reported as not returned in 231 MDRs; therefore, a thorough analysis and determination of likely contributing cause(s) could not be completed for the reported events. Additionally, the manufacturer conclusion in 161 reports was
listed as “unable to confirm complaint,” again not providing a possible or likely cause for the reported event.
•Of the reports which listed that an evaluation was in progress at the time of initial MDR submission, only one MDR, involving the Uphold Lite Device manufactured by Boston Scientific Corporation, stated that a design issue was the most probable cause for the event, with no further information provided.
•The primary patient problem code, “no consequence or impact to patient/no known impact or consequence to patient” was listed in 317 out of 463 MDRs (68%), indicating that in the majority of reports, the device problems experienced did not lead to significant adverse patient consequences.
Overall, the FDA believes the MDR data demonstrate that failures of urogynecologic surgical mesh instrumentation occur and have the potential to adversely affect patients. These data support the need for well-designed instrumentation evaluated to ensure adequate performance, specifications, and labeling.
This report is very long which is why I have only included a few paragraphs. If you are a mesh injured woman you need to read it. If you are a loved one or friend of a mesh injured woman, you need to read it.
I can tell you this. No matter what happened during surgery, you cannot sue your doctor unless the complications are so serious or you die. This is because the hospital administration buys in these kits, believing that the manufacturers have properly designed and tested them. You will never know exactly what happened during your surgery and you will only FEEL the consequences without any explanation by your surgeon.
Women need to get stronger. To question when needed and not except that this is their fate. A lawsuit will not do anything about this and it is up to you to fight to be heard. Every paragraph written in this report, reports facts as the FDA panel sees them. But as injured women we know these consequences go far beyond a few months of pain or a few complications. For many of us the consequences are the result of disabilities that cannot be fixed and we have to figure out a way to live with them.
When confronted by a woman, many doctors refuse to listen and certainly won’t take any responsibility for their own actions. In the end, the result is such that those of us damaged forever, become expendable.
I refuse to be expendable. My life was on track for many wonderful things that my daughter and I had planned together. We never minded hard work to get there because we had a goal of a new future, after my husband’s long and drawn out death, due to dementia. That future was not only taken away from me; it was taken away from my daughter. It cost us financially as well as our lifestyle and I refuse to stay quiet.
I know my life has been shortened by what happened to me that day in March 2010 but I will never know all the facts during that surgery. In the end, I have learned to except that what goes on behind operating room doors will remain silent to me. But I will never remain silent on what happened to my life.
Here is the link to the full FDA report.
If you are a friend of a loved one of and injured woman, after you read that report read this blog. She needs and deserves your support. http://www.meshangels.com/mesh-is-an-illness/