Aug 30 2013

Doctors Sued – Did Not Discontinue Oral Contraceptives Prior to Surgery

Published by at 5:00 pm under Healthcare Reform

A sad case. A 39 year old woman had extensive plastic surgical procedures — a mommy makeover. This included breast lift, tummy tuck, and other procedures. She died two days later from what the coroner labeled a pulmonary embolism.

Now the lawsuit. The family’s plaintiff attorney alleged the patient was taking oral contraceptives. She was cleared for surgery by her internist.  Both her internist and plastic surgeon were aware of the oral contraceptives.

“The combination of birth control pills with a major surgery of four hours or more is a deadly combination,” Pajcic (the plaintiff’s attorney) said.

Paraphrasing –  that’s common knowledge in the medical field, and if doctors had taken Brooke off her birth control, she’d be alive today.

“It’s shocking to me,” Pajcic said.

We can all agree this is a sad case with a bad outcome. And oral contraceptives do increase the risk of venous thromboembolism.

But, the report is silent on whether the doctor utilized any prophylactic methods against venous thromboembolism – such as compression hose, intermittent pneumatic compression device,  Lovenox, etc.

Furthermore, is it realistic to stop oral contraceptives before any activity that might increase the likelihood of thrombosis? Let’s take air travel. It is recognized that the risk of venous thromboembolism increases on flights greater than 8 hours – (prolonged sitting doesn’t help). There’s an increased relative risk – but the absolute incidence is still quite low. So, are primary care doctors – who learn their patients will be going to Europe – under an obligation to advise stopping the pill. While in Europe, stick to abstinence or condoms. Really?

Maybe the patient in the lawsuit had other risk factors – and perhaps she was a suboptimal candidate for any type of surgery. This will come out in discovery.

For now, the dogma that oral contraceptives should be stopped before a plastic surgery procedure will come as news to most doctors. And that dogma is what will be shocking.

 

http://www.gadailynews.com/news/local/135040-widower-suing-doctors-after-wife-s-death.htm

15 responses so far

15 Responses to “Doctors Sued – Did Not Discontinue Oral Contraceptives Prior to Surgery”

  1. Paul Angelchik, MDon 30 Aug 2013 at 6:17 pm

    I enjoy your posts and find them very informative and generally right on. I have to respectfully disagree here. In my plastic surgery practice, we stop po exogenous estrogens ( HRT, OCP) 3 weeks before surgery and allow resumption one week post op. The data is there to show increased risk. In an elective scenario like plastic surgery you don’t really have an excuse not to do this, although many patients are reluctant to do so. I’ve heard many times, “I had a consultation with Dr. X and he didn’t tell me to stop my pills, so why are you?” My answer is that we don’t have any excuse not to lower risk before any elective surgery. If the patient doesn’t agree, then she can go elsewhere, and that has happened as well. It’s unbelievable that a patient would want to take an increased risk for a fatal complication to avoid the inconvenience of stopping OCPs, but it happens.

  2. Michael M. Rosenblatt, DPMon 30 Aug 2013 at 6:25 pm

    I hope that defense attorneys have a chance to look at a Johns Hopkins study which suggested that “preventive measures” do NOT stop all clots:

    http://www.hopkinsmedicine.org/news/media/releases/surgical_site_infections_may_increase_risk_of_deadly_blood_clots_after_colorectal_surgery

    Ok, I admit that this study dealt with colorectal surgery patients; and they were far from elective, in most cases. But the study may have a basis for comparison with other lower extremity, mid-trunk operations. This is certainly a risk factor for foot and ankle operations and others that are done proximal up the leg. For DPMs this is a big deal.

    The main thrust of the study is the apparent concomitant risk of embolism and post operative wound infection, occurring as a combined trait. We don’t know if this patient had a PO infection so soon after her plastic surgery, whether epinephrine was used in the local anesthetic, often given together with sedation, her possible smoking, obesity history, etc. As Medical Justice reported, this will all come out in discovery.

    I am not quite ready to jump on the bandwagon to DC oral contraceptives pre-operatively yet. Then, the patient may sue you for getting “unexpectedly” pregnant. (Surprise!)

    I think it makes sense to alert the patient pre-operatively for that risk, and certainly combining notification of “connection of risk” between post operative infection and DVT. Then, if you see a PO infection, or even an elevated white count you JUMP on the PO antibiotics pronto.

    Truly a sad case. Who to blame? Certainly plaintiff’s attorney has their cross-hairs well in sight. Plaintiff’s attorneys always say that “their presence” is to put pressure on physicians to do better care. At least that’s what their lobbyists say.

    It is unlikely that even with a significant settlement (predictable), that there will be any significant changes in Standard of Care coming out of this very unfortunate event.

    Michael M. Rosenblatt, DPM

  3. David Eon 30 Aug 2013 at 6:27 pm

    Good luck with this one Mr. Money Grubbing Plaintiff’s Attorney. “It’s shocking to me,” Pajcic said., well I wish I could see your face after you spend a whole bunch of time for a whole lot of nothing….shocked is what I’m guessing.

  4. Erik Nuveenon 30 Aug 2013 at 7:02 pm

    Everyone is missing the real issue! Why would any surgeon require more than 4 hours to do a surgery of this nature. Why was it done under general anesthesia. Absolutely inexcusable. It will settle for many millions, as my suggestion to save time and anguish for the defendant.

  5. David Eon 30 Aug 2013 at 9:49 pm

    Nuveen you sound like a lawyer, because you sure don’t know Jacksh*t about these surgeries. My guess, she was obese, smoked, had surgery…..Virchow’s triad, they probably didn’t go over that in your Law school.

  6. Joe Hortonon 30 Aug 2013 at 10:39 pm

    http://xkcd.com/1252/

    Defense rests.

    JH

  7. Scott Kasdenon 30 Aug 2013 at 11:16 pm

    Erik Nuveen, did you happen to see all of what she had done? how long do you take to do surgery- 5 minutes? And really, you have a problem doing abdominoplasty under general anesthesia? Really? Excuse me for being militant, but I find your comments inexcusable.

    You don’t know the first thing about the case, and you make these inflammatory statements. Your comments to my mind don’t reflect what would be reasonable and prudent, but rather arrogant.

    Why don’t you look at this:

    http://www.thetileapp.com/?utm_source=fnws&utm_medium=ar&utm_content=ad1&utm_campaign=300×250

    The ASAPS policy says consider, or strongly consider. There are no absolutes here, so I think the knee jerk rhetoric needs to be toned down. I guess, that includes me. Sorry.

    There are no

  8. David Mobley, MDon 31 Aug 2013 at 12:52 am

    This represents false logic and is a ploy commonly employed by plaintiffs attorneys and expert witnesses. Take an extremely rare and tragic outcome, then tell an uninitiated jury that something “definitely” should have been done to reduce the chance of that outcome. The jury is biased by seeing the event retrospectively instead from the standpoint of the physician who must make decisions without the benefit of knowing the outcome.

    By the same logic each time someone gets killed in a motor vehicle accident we should sue the car manufacturer for making and selling them the car.

    I suspect there are also many examples of lawsuits brought by by women who became pregnant after they were asked to temporarily discontinue oral contraceptives.

  9. Eric M. Joseph, M.D.on 31 Aug 2013 at 9:00 am

    To my knowledge, BCPs are not a relative contraindication for general anesthetic.

    Around 2 years ago at the Vegas plastic surgery conference, a prominent FPS described a DVT and PE occurring “on the table” after a patient had driven several hours to his operatory for elective rhinoplasty surgery. There was difficulty oxygenating the patient along with hypotension. An astue diagnosis was made, and the patient was transferred to the hospital for thrombolytics, and ultimately survived.

    This surgeon concluded that it was unclear whether the long drive or the BCPs or both contributed to this life-threatening event in his 39 year old female patient.

    After hearing that anecdotal story several years ago, I routinely recommend discontinuing synthetic hormones in my patients 7-14 days before undergoing general anesthetic for elective cosmetic surgeries. If the benefits of HRT outweigh the low likelihood of a DVT and PE, I will operate with the HRT.

    It would be interesting to learn the timing of events in this case presentation, as DVT is associated with GA with or without HRT.

    Eric

  10. Michael M. Rosenblatt, DPMon 31 Aug 2013 at 10:33 am

    I have to say that I’m disappointed about the finger pointing occurring here. Not that I’m surprised. This is part of the same “triad” of blame that occurs when as individuals, we are all under attack by stronger powers that supersede our own separate abilities to fix. In this case the legal industry. If it were about another subject, it might be the insurance industry. But the cause is the same. We gave away our political power.

    It is natural to look for your own mistakes. As physicians that is your duty. Looking at this issue, we have our patients stop taking NSAIDS prior to surgery to avoid the risk of intra/post-operative bleeding. Now we must also consider clotting from the other side, stopping hormone replacement therapy or BC pills prior to surgery. HRT is becoming rare now, for other reasons. But some women still take them.

    This is an impossible balance. No perfection will occur. Some people will die after both elective and non-elective procedures. As I am now 70 years old, I realize that this may be me. Or, I may suffer from dementia after being exposed to general anesthesia from a cancer surgery. We hate it to be young people, but young people die too.

    You have a requirement to keep up with the latest literature in your specialty, and this includes the discussion of clotting potential during your cases. When the “incident clock” strikes in your disfavor (and certainly for that patient), I hope you remember that you kept up with the latest issues regarding what you do.

    This includes pointing fingers at yourself. But the system is designed to exacerbate your personal blame, even if there IS none. You did not design that system. It was put into place long before you started your training. And generally speaking, you have allowed your own political leaders to give away your power.

    Michael M. Rosenblatt, DPM

  11. Robert S.on 31 Aug 2013 at 3:17 pm

    I have to say I agree with the plaintiffs here. What’s the point of continuing the OCPs, when the doses of zofran and/or aprepitant for PONV prophylaxis will destroy their efficacy anyways? Do plastic surgeons really expect patients to engage in sex right after an abdominoplasty? (Seems like that’d be mechanically difficult what with all the seroma-preventing pads and girdle!)

    Regardless, pregnancy is not a disease process… PE definitely is and should be avoided.
    Anything that has nuclear effect and increases circulating level of factors 2, 7, 9, 10 and plasminogen and increases platelet adhesion while decreasing antithrombin III should be considered a risk and adjusted preoperatively.

    Women aged 40 are even warned re smoking and OCPs. Can one honestly think that undergoing a substantial surgery is somehow less inflammatory than puffing on pack of cigs?

  12. Michael M. Rosenblatt, DPMon 31 Aug 2013 at 4:55 pm

    I took a look at the latest edition package insert for the combined oral contraceptive: (estradiol and progestin).

    It said to “notify your doctor if you are going to have MAJOR surgery.” (Their capital letters, not mine).

    I’m reminded of the “correct” definition of major vs. minor surgery: Surgery on you is minor. Surgery on ME is major.

    Michael M. Rosenblatt, DPM

  13. H Tobinon 01 Sep 2013 at 8:32 am

    A most interesting article, especially the comments, some of which where quite interesting and some rather disturbing ( i.e. the one by Dr Nuveen ) We are certainly going to consider whether we will advise our patients to discontinue birth control pills. Frankly, I never really paid attention to this and I’m not sure how often it is an issue. I seem to feel that most, if not nearly all, of my abdominoplasty patients are beyond that stage.

    A few years ago, we tried using Lovenox but stopped because of the high seroma incidence. We no longer anticoagulant. We do use compression stockings and are careful to insure early ambulation. Fortunately, we have only had one patient develop a non fatal pulmonary embolus (about 20 years ago) and one minor thrombosis in a small vein. recently.

    What we do feel is of great importance is limiting actual surgery time to about four hours. Many studies have confirmed that risk is pretty steady for that period and then begins to rise. Of course, we all differ in how much we can accomplish in that time. Of primary importance is that we work to our highest skill level. Some of us are just naturally faster than others and may be able to do more. For me that usually means adding one other procedure to an abdominoplasty – either body liposuction of breast augmentation. In some cases, if the abdominoplasty is relatively simple on a rather thin individual, we may add reduction/augmentation to the abdominoplasty. (I rarely do mastopexy any more, much preferring augmentation/ reduction in most cases, but I think mastopexy/augmentation could also be done in many cases within our four hour limit). This all assumes that there are no added risk factors to the overall surgery including smoking, obesity, diabetes or previous bypass surgery.

    The bottom line, in my humble opinion, is that this whole “mommy makeover” concept has led to trouble in too many cases. As I stress to all my patients: “everything we do is elective and there is no reason to add excessive risk to the procedure.” When we stage procedures, we try make financial considerations to that the two procedures do no add a lot extra cost. Sometimes we will do the second within a few weeks of the first.

  14. Michael M. Rosenblatt, DPMon 01 Sep 2013 at 7:57 pm

    Dr. Tobin makes an important point regarding time of surgery. As the owner of my own Medicare Certified Surgical Center (and author of a book and Manual on how to certify such programs/facilities) I am reminded of the Medicare Claims Processing Manual Chapter 14 – Ambulatory Surgical Centers Section 10 -

    “(Rev. 1514; Issued: 05-23-08; Effective: 01-01-08; Implementation: 06-23-08)
    Prior to January 1, 2008, payment was made under Part B for certain surgical procedures that were furnished in ASCs and were approved for being furnished in an ASC. These procedures were those that generally did not exceed 90 minutes in length and did not require more than 4 hours of recovery or convalescent time. Prior to January 1, 2008, Medicare did not pay an ASC for those procedures that required more than an ASC level of care, or for minor procedures that were normally performed in a physician’s office.”

    I assume the above contested procedure was performed at a hospital rather than an ASC. I would hope so. A four hour plus surgery requires more time for anesthesia recovery than ASC’s have the facilities for, or permit. (Unfortunately I was not able to log into the URL describing the above case.)

    Most of our cases averaged 60 minutes. I had a schedule to keep and I also wanted to “sponsor” and provide cases for our residents to do at our training hospital. So I would put longer cases in the hospital for those obvious reasons. Even though we were certified to repair ankle fractures and repair ruptured Achilles tendons in our ASC, I would not do them in my ASC.

    As a general rule, podiatry cases would almost never run more than three hours. Even ankle reconstructive cases involving screws and hardware should be done expeditiously. If you can’t do them in that time, you should refer them to MDs or DPMs who can. There is nothing wrong with getting older. When that happens, it is time change your practice pattern. I did.

    I have had almost 40 clients (MDs and DPMs) who utilized our program and I have never had any complaints from our ASC clients over the “length of time” for their procedures, which in any case, would of necessity match the Medicare requirements for them.

    Michael M. Rosenblatt, DPM

  15. Geoffrey@Health Insurance Digeston 05 Sep 2013 at 12:24 pm

    Well, this is a sad medical case and perhaps proper investigation will help unveil the truth for instance the medical history of the patient and even the doctors practice.