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A “Gold Standard” for Hernia Repair and the Patients’ Post-surgical Understanding of Unreasonable Mesh Device and Procedural Risks?

David Schmidt, FDA hearings September 2011

David Schmidt, FDA hearings September 2011

By David Schmidt

Thank you Jane for this opportunity to share my experience as a U.S. hernia patient harmed, via the standard of care, by two large 4.3” x 6.3,” heavyweight, polypropylene Bard 3DMax Mesh implants. My story begins, as any patient’s does, with the blind trust placed in a physician.

Sen. John Ensign, David Schmidt, Sen. Harry Reid, U.S. Capital, July 29, 2010.  Both U.S. Senators are holding their copy of the July 29, 2010 letter I sent to the Senators of the 112th U.S.  Congress requesting a hearing/investigation of the surgical mesh industry.

Sen. John Ensign, David Schmidt, Sen. Harry Reid, U.S. Capital, July 29, 2010. Both U.S. Senators are holding their copy of the July 29, 2010 letter I sent to the Senators of the 111th U.S. Congress requesting a hearing/investigation of the surgical mesh industry.

On April 18, 2007, under what I would only later understand as false and misleading pretenses, I illegally consented to have a surgery performed to repair a “small left inguinal hernia containing fat (identified in a CT scan).

Also, mentioned at the time of the pre-surgical office consultation, to the surgeon who would ultimately perform the surgery, was my experience of discomfort (understood then as “pain”) on the right side of the groin occurring during more physically demanding activities. At the surgeon’s recommendation, it was mutually agreed upon that he would approach a surgery laparoscopically, to determine during surgery, if there was also a hernia in the right groin which the CT scan had not identified. The surgeon’s written “impression” from that office consultation was: “1. Left inguinal hernia; 2. Possible right inguinal hernia.”

 

When laying on the gurney, prepped for surgery, I was handed a consent form that stated: “Laparoscopic Bilateral Inguinal Hernia Repair.” Almost immediately after receiving the form, very concerned, I remember asking (I believe) the same women who had handed it to me why it stated bilateral repair – the surgeon only thought I might have a hernia on the right side. She responded, in a way which I interpreted both as explanatory and to insinuate only a stupid person would not know this reason why, that if I did not sign to have both sides done the doctor would not be able to repair the other side if needed.

 

Left to think it over…what would there be to “repair” if there was not another hernia found? Mesh, I had been told, was like stitches but better since I would not have to worry about a hernia again. Logically assumed at that time, and as mutually agreed upon during the pre-surgical office consultation, it had been my naive understanding that there would also have to be another hernia found, to then “repair.” This is not my understanding today.*

 

* As a non-physician member of The American Hernia Society (AHS) for over the last 5½ years, I have had the first hand opportunity, while an annual conference attendee, to learn both about the far-reaching intended use of mesh (to reinforce) and the magnitude of this industry’s knowledge of patient harm from use.  

 

Having never had a surgery performed before (except for my wisdom teeth removed as a teenager) and although it did not quite make sense to me at the time, I conditionally signed the consent form, when verbally telling the same woman who had answered my question about why it stated bilateral repair (upon handing it back to her) that I needed to talk with the surgeon before the surgery. In a rush, the surgeon told me not to worry, as we had agreed upon, he was still only going to repair the right side if needed.

 

In the operative report this surgeon would later write:

      “The camera was inserted. We [referencing the other surgeon who assisted him] visualized the pre-peritioneal space, which had been dissected by the balloon before. We elected to perform right herniorrhaphy first. The peritoneum was dissected away from the anterior abdominal wall, exposing the inguinal floor. It appeared the patient had a direct defect in the right inguinal space, medial to the inferior epigastric vessels. The peritoneum was dissected back. The cord was identified and expected for any signs of an indirect hernia or a cord lipoma [fat]. There was none.”…“Procedure was repeated on the left side, dissecting the peritoneum away from the anterior abdominal wall, and exposing the cord structures. There was no direct inguinal hernia. The cord was inspected and noted to have a large cord lipoma.” Following which “…again a large, left 3DMax Mesh was placed into the pre-peritoneal space….” The postoperative diagnosis stated: 1. Right Direct Inguinal Hernia; 2. Left Cord Lipomas (emphasis added).

 

It is my understanding, derived from the preceding documentation, that there was pre-surgical, surgeon intent to “repair” both sides regardless whether or not there were any hernias found. This was in violation of my informed consent. Never did I knowingly, legally consent to a surgical procedure to have my groin reinforced with 8½ x 12½ inches of mesh. Logically, thinking about it later (when understanding the device implanted), had there not been pre-surgical intent to perform a bilateral mesh implantation procedure – why were the surgical sides not marked before surgery? Bard 3DMax Mesh has both a right and left side orientation. It would also appear that both surgeons were unable to even correctly identify the surgical sides, as the CT scan identified a left not right hernia.

 

Never was I told what specific mesh device would be implanted (it was simply “mesh” – there are hundreds of hernia mesh devices currently on the market), the number of devices intended to be implanted, general and very mesh specific device risks, and the heightened immediate and long-term laparoscopic surgery specific risks. When I asked about risks, I was only informed of general surgery risks. In regards to mesh benefit, I was told that a mesh repair was permanent and that tissue repairs were not done any more because they (the repair) would probably just fail.*

Dr. Byrnes Shouldice and David Schmidt, taken at the 2012 International AHS Conference (Congress) in New York, NY.

Dr. Byrnes Shouldice and David Schmidt, taken at the 2012 International AHS Conference (Congress) in New York, NY.

 

* As an annual AHS conference attendee I have had the privilege to speak, at length, on numerous occasions with Dr. Byrnes Shouldice (son of Dr. Edward Earle Shouldice, the inventor of the Shouldice tissue repair). The Shouldice repair, still preformed at very high success rates by The Shouldice Hospital in Ontario, Canada, evolved as the gold standard of hernia repair before the onslaught of mesh repairs overtook the standard of care in the ’80s to mid ’90s (contributory to the dawn of the “minimally evasive” laparoscopic surgery). It is my firm and unwavering belief that patients are being deprived the success of tissue repairs, specifically, the quality of the Shouldice repair. It is a travesty that patients are being needlessly harmed by unwarranted mesh abuse, if not for the regressively trained surgeon reduced to indiscriminately abuse mesh, those patients specifically, could have benefited from surgical intervention.

 

Only later would I understand, that the in vivo placement of mesh is both meant and understood as permanent, the repair is not. As for the safety and effectiveness of mesh, if mesh was like stitches – stitches still seem like a reasonable general surgery risk. Both I, at the time of the April 2007 surgery, and implant surgeon when asked during his January 24, 2012 deposition, knew nothing of 510(k) device clearance. During his deposition, when also asked why he uses mesh, he stated “recurrent risk tends to be higher without mesh.” (He did not even know that Bard 3DMax Mesh was never FDA approved for safety or effectiveness.) There are no performance standards “applicable” to surgical mesh.

Very predictable to the industry understanding (documented in the medical literature) for high patient chronic pain rates to following the modern mesh hernia repair, repetitiously echoed surgeon opinions to give my developing and becoming more debilitating, postoperative complications more time to “heal” ensued. Misleading physician documentation would precede my “persistent inguinodynia” (groin pain).

In the months following my fourth and final post-surgical appointment with the implant surgeon (concluding with him walking me to the door of his office, documenting he told me if I was “unhappy with [my] outcome” I was welcome to seek a second opinion), I would describe the experience of “an alien/foreign sensation [in my groin] as if two pieces of cardboard are moving, becoming slippery, cutting and jarring into the insides of my flesh adjacent to my hip joints.”

 

Davol Inc., Sub. C.R. Bard, Inc., the manufacturer of Bard 3DMax Mesh, markets these implants to not require fixation. This particular mesh device is sized as small and large to universally “fit” the anatomy, in an apparent attempt to keep a non-inert mesh device in place until the unpredictably of the scarification response possibly occurs. Early on in my attempt to understand what was going on, in a response letter to mine here, February 2010, C.R. Bard, Inc. stated that even they, the manufacturer, are unable to predict the outcome of the scarification response. In this same letter, however, they also shared with me their belief that “[3DMax Mesh], and other products produced from the same materials, has [had] a long history of safe and very effective use in the repair of inguinal hernias.”*

 

* Less than four months before the first corrective surgery, and about 14½ months after the April 2007 implantation surgery, I sought the expert opinion of a long-time general surgeon at a “world renowned” clinic in Rochester Minnesota. He stated in his “To Whom It May Concern” letter that he had “seen nearly a thousand patients with chronic groin pain.” And, “it [had] been [his] experience that pain tends to get better over time. As the brain adapts to this discomfort, patients become more functional.”

 

On October 21, 2008 I underwent the first exploratory/corrective surgery. On September 3, 2009 I underwent the second. By my own estimate, the combined duration of these two surgeries was around 9½ hours. Both Bard 3DMax Mesh implants were found in a progressively contracted, harden state and observed to have migrated, adhered to the ligaments, bladder, spermatic cord, nerves and intertwined with the blood vessels of my severely inflamed groin.* The explant surgeon estimated that about 5% of the implants remain non-recoverable because of the risk of removal from critical groin structures.

 

* It is Industry understood that both the larger and heavyweight polypropylene meshes are associated with more acute in vivo inflammatory responses. Mechanical pressures in the groin from 3D mesh design are also understood contributory to higher incidents of patient chronic groin pain.

 

Today, almost five years after the last corrective surgery, I still do not have a recurrence of my small hernia containing fat. The doctor who performed both corrective surgeries did not see any evidence of a hernia (therefore, perhaps due to scar tissue, there was nothing to repair*).

* Contrary to physician documentation in my medical records, I never saw a hernia bulge. Doctors documented seeing a bulge; one even documented seeing two hernia bulges. I was lead to believe that a hernia was the reason for my “pain” and underwent a surgery to address a hernia(s) as the cause. Never was I informed of a possibility to post-surgically experience groin pain. I had no grasp on a reality that the suggested use of mesh, as the “treatment,” would result in the very outcome I sought to address (with initial discomfort perhaps only temporary but chronic pain following mesh implantation permanent).

 

What was left understood in the case of DAVID SCHMIDT vs. C.R. BARD, INC., et al., CASE # 2:11-CV-00978-PMP-PAL (in which I was the Plaintiff) was that the Court was not swayed “that Plaintiff’s hernia repair could have been accomplished without use of the 3DMax Mesh.”

And, in regard to “evidence to show that the design of the 3DMax Mesh in question was the legal cause of the injuries alleged by Plaintiff,” my request to the Court to consider that evidence was DENIED. As it is my shared belief too, that my hernia “repair” could not have “been accomplished without the use of Bard 3DMax Mesh,” I also believe, had the Court considered the evidence of the case, there would have been sufficient cause, to raise a fact issue: “that the design of the 3DMax Mesh in question was the legal cause of the injuries alleged by Plaintiff.”

Had I been legally informed of unreasonably dangerous, very specific device and accompanying heightened laparoscopic surgical risks, I could and would have acted to prevent my injuries.  Now understanding the reality for the numerous benefits from a tissue repair, I would have sought out a competent surgeon, to proactively address – upon ability to successfully perform a quality, non-mesh hernia repair – a true hernia. I erroneously believed mesh would be used like a band-aid, and like a band-aid, sized proportional to an actual hernia defect. If this was the case, upon market clearance, Bard 3DMax Mesh could not have been injuriously sized to “fit” patient anatomies, in an apparent attempt to mitigate its very foreseeable migration, as a non-fixated mesh device.

It is my belief that the game-changer needed now, to protect future potential U.S. medical device implant patients, unequivocally involves the universal recognition of each and every patient’s civil/Human rights. To that end, as suggested to FDA Commissioner Margaret A. Hamburg, M.D., in my July 22, 2014 open letter requesting appropriate FDA action (David Schmidt July 22, 2014 FDA Docket Response-1), The Universal, Two-Step, Implantable Medical Device Patient Informed Consent Process will shift the paradigm to/for the patient perspective. Knowledge will then empower the appropriateness of patient response. #

 

Learn More:

David Schmidt – July 22, 2014 open letter here addressed to FDA Commissioner Margaret A. Hamburg, M.D., copied to  Docket No. FDA-2014-N-0297.  David Schmidt July 22, 2014 FDA Docket Response-1

 

David SchmidtFebruary 24, 2010 Bard Letter to David Schmidt

Feb 24, 2010 letter to Schmidt from C.R. Bard Please note: At the text here attach PDF document: [July 22, 2014 Bard Letter]

Feb 24, 2010 letter to Schmidt from C.R. Bard

17 Comments

  1. All Meshed Up says:

    Your story, David, mirrors so many Hernia mesh victims. We were lied to about the safety and hazards of having a mesh implant. Then after the implant, when there is great pain and discomfort, WE are blamed for the pain we are experiencing. Whether “It is in our head” or” we just have to be patient” or ” I believe you are just wanting Narcotics” the Doctors will blame anything other than the mesh. There are more Hernia victims than gynecological victims yet we get no publicity as do the vaginal meshes.

    Bruce has told me about your experiences with mesh and the Doctors. I find it hard to believe that you cannot sue the pants off of Bard or the Doctor. But that is the way it is when the FDA is in collusion with the Manufacturers. With 100’s of 1000’s of Hernia Mesh victims out here suffering in one degree or another, the FDA is completely silent. It is not until the FDA bans or recalls all mesh products, especially those made of Polypropylene, none of us will get any retribution against the manufacturers. Then I want to go after the FDA for collusion and protecting the manufacturers throughout the lawsuits and public inquiry.

    Best Wishes, David

    • David says:

      Thank you for your response and kind words of support.

      I think one of the major problems with surgical mesh (regardless of indication) is that the effectiveness consideration for patients from its use is an afterthought to both the heightening of surgeon efficacy benefit and profit opportunity afforded to industry with increased use.

      The suggested “mandatory” FDA medical device reporting requirements do not equate the patient experience of harm; without the prelude of surgical intervention, there is no requirement to report an adverse event. And, specific to mesh hernia repairs, surgical intervention is reserved, almost exclusively, to address the obvious surgeon problem of hernia recurrence – not the reason for, the subjective patient experience of lack of treatment effectiveness (chronic pain). The prevention of patient harm (by mitigating mesh risk, and then chronic pain from abuse, to a once responsible, unwarranted historical use), would however, be counterproductive to the manufacturer/surgeon societal goal fixated upon maximizing its own one-sided benefit.

    • cindy says:

      hi there, just found your comment, I too have two hernia mesh implants and living in hell just found DR Patterns in Vegas who is taking it out successfully but its 9,000.00 just for the surgery plus travel and I have already spent everything, lost my marriage from being so ill, lost thousands of dollars trying to find help, now on pain and nerve meds that are really messing me up, I have no family nor ability to get a loan due to I had to file chapter 7 after these surgeries, have you ran across anyone who is or can direct me to finding help to get the monies to have these meshing taken out, I have tried doing fund raising on line but not any response yet and its been over a week now..thanks for your time cindy

      • Jane Akre says:

        Have you checked into Dr. petersen in Las Vegas… hernia mesh specialist? It sounds like a lot of money…. please check with him….. to price comparison. Do you have your medical records?

  2. George says:

    Thanks David,

    Agree very much with you and AMU.

    Having similar and continuing problems with hernia mesh implants and ex-plants, I fear too many “positive outcome” mesh patients are misdiagnosed and have meshoma of some form, which erroneously creates the high percent of acceptable outcomes for mesh use. The larger picture is the US is that we are the only industrialized nation that makes very large profits off two vulnerable segments of society; those in need of an education and those that need health care. Changing social status-quo in a business profit at all cost society is not likely without a tremendous shift in values. This FDA – AMA – Medical Device triangle is not open for input and requested improvements from patients. MAUDE reports and lawyers attempting to advocate for patients rights only seem to create false hope. This is not a Walt Disney movie and for most of us the daily routine of chronic pain is not a happy ending.

    G

    ps – Thank you Jane for your dedication!!

    • David says:

      Hi George,

      Thank you for your response. Great comment about “…those in need of an education and those that need health care.” So true it is…as this industry’s opportunity is exploited in the vulnerabilities of patients with a lack of education and in need of healthcare – “very large profits” are subsequently made. And as you said – this is not a Walt Disney movie with a happy ending (with patients left to live out the manifestation of nightmares from the unaddressed known and unknown reasons for chronic post-operative pain), and as AMU said – “…the Doctors will blame anything other than the mesh,” I would like to also add that if those surgeons reduced to indiscriminately abuse mesh did not have the mesh to blame they would be forced to blame themselves for not acting in their patient’s best interest. This brings us to the informed consent threshold: Why is patient informed consent even necessary if not for the surgeon’s inability, and/or gross failure of ethical intent, to have acted in their patient’s best interest?

  3. Courtney says:

    Hi David- thanks for your informative article. I now have a hernia, it happened months after mesh removal in the incision area. I am very concerned about getting it repaired due to the fact that most general surgeons favor mesh. Ironically hours prior to reading your article I had contacted shouldice hospital for a consult appointment. Do you think they still hold the same standard that they did years ago? I noticed they talked about tissue repairs on their website. When I phone they stated it was hard to give an opinion until they examined the area. Although its no fault of the mesh removal surgeon, it is about the worst thing that can happen at this point considering most all surgeons want to put in mesh to repair a hernia which is in no way an option for me . I am mesh free finally and if it comes down to it I would prefer to put duct tape on the outer area if I got desperate before I would ever let anyone come near me with mesh. And duct tape does come in some cute designs now a days!!

    • David says:

      Hi Courtney,

      I too would prefer the duct tape (or watchful waiting) approach if I ever had firsthand, empirical evidence I developed an actual hernia. It is my understanding, since your hernia is no longer a primary hernia, that any surgeon who is able to competently perform a tissue repair, would first need to examine the area to determine if a tissue repair is still a viable option. The tragedy facing patients following the aggressive use of mesh as the first, not last, approach to hernia repair is that it becomes very changeling for a properly trained surgeon – proficiently able to successfully perform a tissue repair – to then approach a mesh failure, conservatively without mesh, in a patient’s best interest. The sad reality for patients undergoing primary hernia repairs is that they either subject themselves to the current, unreasonable risk of illness and injury from indiscriminate surgeon mesh abuse or seek no treatment (watchful waiting). This is NOT the progression of medicine!

      I can certainly understand, upon successfully getting a previous mesh out of your body, the prospective of undergoing another surgery in which mesh use might possibly be warranted (to again address the failure of the initial surgery –as I also agree “…its no fault of the mesh removal surgeon”…he/she acted in your best interest) would seem counterproductive to a proactive healthcare choice. I can empathize with your situation and the very difficult choice you face. If I can offer any advice to you, put your resources into getting the best opinion(s) possible before limiting your choice to having another mesh put in. (I think you are on the right track with The Shouldice Hospital.) And, regardless if any surgeon feels confident that he/she can still successfully perform a tissue repair, discuss with that surgeon what type of mesh they would have to use if it was warranted.

      Consent to a surgery with the understand that since no 510(k) cleared surgical mesh device was FDA approved for safety or effectiveness – “substantial equivalence” was the FDA’s finding: that one mesh device is no less dangerous than the next mesh device.

      Best of luck to you

      • Courtney says:

        Hi David,

        Thank you for replying to me. This situation is very worrisome. The original mesh was not for hernia repair, it was a bladder sling . Due to mesh migration and much trauma to the area it finally was removed from I have developed this hernia. Which, I had confirmed a few days ago. I cannot consider mesh. I had an autoimmune disease disappear when mesh came out. Mesh stole many years of my life. For the first time I am free now. If my own tissue is too damaged can they use a fascia from

        another part of the body? I hope Shouldice can help as I will be travelling there next month. Let me know if you heard of the fascia from another part of the body being used. Many thanks.

        • David says:

          Hi Courtney,

          I do not know anything about the use of fascia, from another part of the body, for the repair of a hernia. I was talking to Bruce Rosenberg with the National Meshoma Foundation about your situation and he would be willing to talk with you about his experience speaking with hundreds of patients over the years who have also found themselves in similar, very challenging circumstances. You can email your contact information to Bruce at brosenberg1@bellsouth.net.

          Sorry I can not be more help. If I could offer any advice to you it would be to write out the questions that you want to ask the surgeon before the office consultation, so even if he/she cannot offer you surgical intervention, your may find answers to some of your questions. Akin, to most, if not all patients who are left to deal with surgical mesh complications (which they were very likely not legally even informed of), knowledge of both viable treatment and non-treatment options will help you make the best choice possible.

          Take care.

        • abandoned says:

          Courtney, How much trouble was it to have your mesh removed and do you mind sharing your surgeon’s information?

          Good Luck with the hernia….You are the first mesh sling patient that I have heard was able to get it entirely removed.

          Kindly,

  4. David says:

    Due to the fact that I was trying to limit my word count in describing my experience (by adding emphasis), I would like to take this opportunity to elaborate further on my interpretation of the referenced text section from this April 2007 operative report. Although it would “appear that both surgeons were unable to even correctly identify the surgical sides…” (via “we [referencing the other surgeon who assisted him] visualized…”), there is another plausible explanation for a confusion between surgical sides: The CT scan actually identified a left cord lipoma, “…which [is] associated with an indirect hernia,” as stated by the implant surgeon during his January 24, 2012 deposition testimony.

    A factual interpretation of reality (via the CT scan) would support a surgeon’s written account in an operative report that: “the [left] cord was inspected and noted to have a large cord lipoma.” It would, however, contradict both this surgeon’s postoperative diagnosis indicating there was more than one cord lipoma (as his postoperative diagnosis stated “left cord lipomas”) and his testimony during his January 24, 2012 deposition, when stating (upon referring to his notes): “we saw cord lipomas” (“we saw” = “we visualized”).

    Problematic to the right side – the right side unlike the left side in the operative report, was referenced in past tense with the words “it appeared the patient had a direct defect…,” while contrasted to the left side (ten lines later) with the word usage: “the cord was inspected and noted to have a large cord lipoma” (referenced in present tense). (To have “had” and then “have” this preceding relationship, at a near proximate time interval, is contradictive to coherent logic.) During his January 24, 2012 deposition, however, the implant surgeon would later state (upon referencing his notes) “we were looking at the right side first. We noted him to have a direct defect or a direct hernia on that side.” It now, no longer “…appeared the patient had a direct defect…”; the patient was “noted” to affirmatively “…have a direct defect…” on the right side.

    The CT scan did not support the surgeon’s finding of “a direct defect or a direct hernia on [the right] side,” only a herniation of fat on the left side – first identified during surgery by the surgeon as “a large [left] cord lipoma” (“…associated with an indirect hernia”) and then, following in his postoperative diagnosis and later during his deposition, as “left cord lipomas.” An understanding that a direct hernia will repair itself to support a surgeon’s factual finding that: “it appeared the patient had a direct defect…” defies logic –consequential to a portrayal of truth: hernias are not understood to magically repair themselves. It is my belief that the implant surgeon rewrote reality to justify his premeditative, pre-surgical intent to inflict excessive risk (and then subsequent abusive use of force) with his intended implantation of two Bard 3DMax Mesh implants.

  5. Angie says:

    Why is it so hard to get any information on the Bard3Max Mesh Meduim? My husband had surgery on July 14,2014 and has the same symptoms as everyone who had the large and small mesh ! He started breaking out 2 days after the mesh was put in and is in more pain now then when he had the hernia!

    • Jane Akre says:

      Please direct your questions to Bruce Rosenberg,,, 954-701-5094. He can answer your questions about hernia mesh. He has a nonprofit concerning hernia mesh injuries. Keep trying, he’s sometimes hard to reach.

    • Wendy says:

      Hi Angie,

      I also had a hernia repair with mesh on July 14, and have been in pain ever since, worse than the original hernia pain. I am wondering if you would share the symptoms your husband is suffering from, as I am experiencing strange and painful symptoms that I suspect are from the mesh, yet my surgeon just keeps telling me it’s not the mesh. At this point I am desperate to know if it is indeed the mesh, but I am having difficulty finding others who have experienced this, and what their symptoms are, and if they match mine.

      Thank you so much.

  6. moira says:

    In 2000 I had abdomnioplasty and hernia repair with 9×9 piece of Marlex sheeting…For 10 years I was fine. Then it started happening the rapid weight loss 80 pounds in 10 months with no explanation….stomach issues intestinal issues..now I have a sharp searing burning pain that feels like a hernia again. Ultrasound shows nothing..ive been scoped up and down..all he found was polyps in my large intestine…Now im going to a plastic surgeon again to have my mesh assessed. I think there is a tear in my mesh and I think its breaking down chemically in my body making me sick. Been off work a year now and my quality of life is at best manageable..Im on narcotic pain killers for the pain..on medication for stomach and intestines…Theyre investigating further now cause I told my nurse practioner I thought it could be my mesh…Im looking for a lawyer in Canada that deals with this. Any help would be appreciated..

  7. Jen-Ann says:

    Hi David
    Hope you are doing well!
    MN
    Jen

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