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 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.
* 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. #
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 Schmidt - February 24, 2010 Bard Letter to David Schmidt
Feb 24, 2010 letter to Schmidt from C.R. Bard