You may be surprised to learn just how your doctor purchased the pelvic sling he put in your body. Truth is, he didn’t have to lift a finger. His sales rep brought it to him. Moreover, there is a good chance your salesman watched your doctor put it in you and, he may even have “scrubbed in” and performed part of your surgery.
It is no accident that your surgeon “forgot” to mention the manufacturer’s rep might be in your surgery. Manufacturers are well aware that the practice is very controversial and don’t want you to know. David S. Hilzenrath discovered the obfuscation while preparing for his 2009 Washington Post story about salesmen boosting sales by participating in operations:
“(S)ome companies want nothing to do with a story about sales rep in the operating room.
“‘I would hope that you would not mention Boston Scientific in your story,’ a spokesman for that company e-mailed.
“Major device makers such as Johnson & Johnson, Stryker and Zimmer declined to arrange interviews for this article.”
Mesh injured women began realizing that manufacturers invaded their surgeries, not when they were asked to sign a consent for an observer to be there while their genitals were being operated on, but afterward when they found evidence by reading their own charts. Detail men around the world routinely attend surgeries to make sure doctors don’t use competitors’ products.
In 2008, Ronda Yancy (not her real name) was appalled when she retrieved her own medical record: “I found out, after my surgery, that a Johnson & Johnson Gynecare sales representative was in the O.R. with me.”
Yancy, who died at 52, after living her final years dealing with mesh complications and a string of illnesses, had been implanted the Gynecare Prolift (a polypropylene-based surgical mesh device used to treat pelvic organ prolapse). The Prolift was first introduced by J&J in 2005 without an F.D.A. approval and was soon the source of alarming federal complaints. It wasn’t removed from the market until a year after Ronda’s death, in 2012.
Ronda’s pelvic sling sawed itself out of the space it was supposed to be and into her vagina, causing her suffer years of infections and disabling pelvic pains. “I sure never thought that some day I’d be crying just cause I can’t stand to wear underwear anymore, much less pick up my grandkids,” said Ronda. “After the surgery I couldn’t walk properly and am in constant cutting pain. Doctors say I am the first patient to ever have problems.”
After Ronda posted in an online support group, others began to look at their operative reports and at least three found that salesmen had been in the room with them while they slept. One said she felt like she’d been “drugged and raped.”
One nurse wrote to the group, “The hospital loves for the reps to come in because their labor is free and they provide free products to use. The reps bring in pizza dinners and cater lunches from time to time and so the O.R. staff loves them too.
Bill Mackay, a high school drop-out and device salesman who performed the major part of a surgery that crippled a man in 1975, was never mentioned in that patient’s chart. He later wrote in a tell-all book, Salesman Surgeon, that he took over lead surgeon, David Lipton’s position during a hip replacement, ordered the nurse to hand him sharp instruments, hammered and chiseled away at bones and removed one hip prosthesis and implanted another. He said it was the “one of nicest pieces of surgery (he’d) ever seen or done” but the patient, Franklin Mirando didn’t agree. The forty-two-year-old service station owner never walked again after Mackay was done with him.
In 1977, criminal charges for assault and misrepresenting business records were made against salesman Mackay, two surgeons, a nurse and the Smithtown General Hospital. Investigations were launched by both state legislators and the Sulfolk County Medical Society. Despite all the hoopla, the charges were eventually dropped and the manufacturers across the country began to have free rein inside operating rooms.
What could possibly go wrong when you send wet-eared salesmen into an operating room? In 1998, another device rep was sued after he operated a machine during a fibroid removal surgery and 30-year-old Lisa Smart died within hours. Lawyers found Lisa’s surgeons had botched many aspects of her surgery including overloading her with fluid. She drowned. Her husband’s lawyers were also shocked to discover Johnson & Johnson sales rep, David Myers, was operating the dials on the unauthorized machine that delivered electrical impulses to her uterus. “The patient was never given the chance to consent to the use of the equipment or the presence of the salesman,” the New York Times reported at the time. The hospital a was fined $30,000 and Myers disappeared from sight. Yet again, in the face of another disastrous outcome, device marketers stepped up their pace.
Classes for prospective salesmen include topics like: “how to get inside a surgical suite without an invitation” or how “to sell without making the surgeon feel that he’s being sold” or even “the art of engaging surgeons in conversation.” Candidates are invariably young, good-looking go-getters whose training lasted no longer than a few weeks. Although a college education is recommended, it is not always required. Despite the fact that pelvic mesh sellers are given an unfettered view of your genitals, there is no evidence that they were ever required to go through a background check–although your nurse sure was.
Recently, two pelvic mesh recipients found out that salesmen had been with them by reading their charts. One woman noticed a set of unfamiliar initials next to “Ass.,” or assistant surgeon, on her operative report and set out to investigate. She found another document with the full name spelled out and remembered her surgeon mentioning he was going to “ask the advice” of his salesman with the same name. She was never told he would be there. A modest woman, she can’t digest the fact that a total stranger was afforded a clear view of her most private area. As if to compound the emotional harm from realizing a salesman had seen her tilted backward, legs spread on an operating table, she said the same sales rep later visited her in her home–right after she made an official complaint about her mesh injuries.
It the manufacturers are working hard to hide the presence of salesmen in operating rooms, there is no way to know if, when your transobturator-tape was pulled to tight, it was really the detail man who tugged too hard on that trocar or if his scrubbing technique was not up to standard and that’s why you had a post-operative infection.
If you would like to look up your medical record, be prepared to put a little wear and tear on your shoe leather. Go to your hospital medical record department in person and ask for the complete report of your surgery, including the label for you implant. Most medical record departments provide only the surgeon’s dictated report, especially when you ask by mail, but there is a lot more paperwork than that. Look for your consent, your anesthesiologist’s minute-to-minute accounting, your nurse’s count of sponges and instruments, and your interoperative report, which should contain the names of everyone who attended your surgery.
Yancy felt she was invalidated every step of the way after her implant. Doctor after doctor told her, “Mesh is the gold standard, it can’t be the mesh.” She summed it up in one word saying she had been “Gaslighted,” a reference to the 1944 movie, Gaslight, in which Charles Boyer pulled dirty tricks on Ingrid Bergman and then told her she must be going crazy–all the while pretending he had her best interest at heart. What a perfect phrase. Are you being Gaslighted?
Peggy Day is working on an investigative report on pelvic mesh salesmen in the operating room. She welcomes any input you may have about the questionable practice.
If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, check the list of support groups here.
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