Investigation 11HDC00531 Death # 2

https://www.hdc.org.nz/decisions/search-decisions/2014/11hdc00531/

This case involves the first of two patient deaths from one DHB, by the one surgeon. The outcome of the HDC investigation leaves an open, unanswered question. Did the HDC give a ‘free pass’ to the surgeon; as a result of the HDC’s own application of the legally enforceable Code of Rights? Arguably, the lack of action from the HDC, yet again, has reinforced their unwritten policy of ‘learning not lynching’ of medical professionals and protecting them, rather than holding them accountable. Resultantly, there was another preventable patient death six months after this investigation ruling. (See 12HDC01488)

Recap: Just prior to this patient’s death, in an unpublished ruling, the HDC took the extraordinary steps to whitewash consumer complaints about the method that New Zealand surgeons obtained consent for cholecystectomies, which as we continue to emphasise, have been obtained illegally through deceptive and fraudulent means. The HDC was strongly advised it too would breach the Code of Health and Disability Services Consumers’ Rights and would be held accountable for personal damages, such as loss of income and even loss of (life) expectancy, for every cholecystectomy carried out in New Zealand, if it failed to investigate breaches and enforce cholecystectomy patients’ rights as mandated by the HDC Act.  In a truly shocking outcome, the HDC chose to ignore its own non-surgical recommendation, which would expose New Zealand surgeons that were deliberately lying to their patients. Subsequently, the HDC continued to ignore the lack of chronic side effects and alternative non-surgical treatment options of cholecystectomies that were not being presented to patients.  Remarkably, the HDC doubled-down on this stance with the following ruling on informed consent requirements: When the New Zealand surgeon explained the general and specific complications of the procedure, (see $100K reward link); they listed the types of complications as those arising interpretatively, or well-recognised post-operative complications such as bleeding, or infection. The HDC did not consider that further medical advice is necessary. “Removal of the gallbladder is generally considered to have no lasting consequences, although some people experience more frequent and less formed stools or diarrhoea”

2. Take home points

• This unfortunate death, and a second following shortly after, may never have happened if:
  • The HDC had not given a mandate for New Zealand surgeons to withhold informed consent. (Honest and transparent) 
  • The HDC acknowledged their unsatisfactory application of the legally enforceable Code of Rights that supported their unwritten policy of ‘learning not lynching’ continuing to protect medical practitioners and not hold them accountable.
• The HDC protection extends to obstructing natural justice to family members of victims/patients:

Everyone (including the HDC for misusing using their statutory powers) is liable to imprisonment for a term not exceeding 7 years who conspires to obstruct, prevent, pervert, or defeat the course of justice in New Zealand under Crimes Act 1961. Public Act 116 … www.legislation.govt.nz/act/public/1961/0043/latest/DLM329005.html

• The following breaches of the Code of Rights were not investigated:

Right 6(1)(b) Every patient have the right to the information that a reasonable consumer in his circumstances would expect to receive, including an explanation of the treatment options available and an assessment of the expected risks, side effects (affecting quality of life), benefits and costs of each option. Failing to disclose the risks during the informed consent process breaches Right 6(1)(b) of the Code of Health and Disability Services Consumers’ Rights (the Code). Right 7(1) –Informed consent is obtained illegally, by fraudulent deception.  Every consumer has the right to make an informed choice and give informed consent. Services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent. Without this information, patients are denied that opportunity to legally give informed consent. Right 4(4) every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of the consumer.

3. What Happened

• A General Practitioner (GP) referred a fit and well, young, 31-year old woman to the surgical service at DHB. Noting that she was experiencing daily right-side abdominal pain. An ultrasound showed a single 14mm gallstone.
• It was agreed that Ms A would have a laparoscopic cholecystectomy in the near future. She was prescribed a five-day course of antibiotics in the interim. No other non-surgical treatment options were discussed, and it would appear, nor were the risks of bleeding, resulting in blood transfusions ever revealed.
• The surgeon failed to read the patient’s files and pre-admission forms, which all detailed a directive not to receive blood products. The surgeon also fails to attend a ‘time out’ meeting to discuss the risks, which included the directive.
• The operation proceeds without completed consent documentation. Sadly an injury occurs, there is uncontrolled bleeding and the patient dies.

4. The HDC Investigation Outcome

On the surgeon: “This was a failure to provide services with reasonable care and skill and, accordingly, a breach of Right 4(1)” Every consumer has the right to have services provided with reasonable care and skill.

On the Anaesthetist: “Failed to take reasonable steps to co-operate with his colleagues to ensure quality and continuity of services. This was a breach of Right 4(5) of the Code”

On the Nelson-Marlborough DHB:  The arrangements and systems in place at Hospital 1 did not support the timely communication of this information. In addition, Ms A’s refusal of blood, despite two staff believing it was discussed in the surgeon’s missed ‘time out’ meeting and added – blood products should have been raised during the surgical “time out”. The NMDHB breached Rights 4(1) and 4(5) of the Code of Health and Disability Services Consumers’ Rights (the Code).  

5. Breaches of Patient Rights Not Investigated (Unanswered Questions)

Doctors have a statutory obligation to abide by the Code of Health and Disability Services Consumers’ Rights (the Code). Under the Code, every patient has the right to make an informed choice and to give informed consent. This never took place and the HDC ensured a criminal office was never unearthed. The patient was robbed of their right to make an informed choice that was free of coercion and deception and concealment of risks. The patient was also robbed of their right to fully understand and comprehend the side effects of surgery and alternative non-surgical treatment options.

Patient “autonomy” or self-determination is at the core of patient’s right to give informed consent. Doctors are legally required to provide patients an explanation of:

1. Alternative treatment options available,
2. Side-effects (of surgery affecting their quality of life); and
3. Assessment of the expected risks

There is no evidence stating that alternative treatment options were recorded as being discussed with the patient, or documented in the Nelson Marlborough DHB informed consent. Nor were they detailed in a patient informed consent handout or information guides. Consent was not legally obtained and a criminal offence occurred.

The surgeon is required by law to advise provide non-surgical treatment options during the informed consent process. The following question should be asked of the HDC:

• Why was Oral Dissolution Therapy not considered when gallstones were first identified in CBD and gallbladder?
• Why was there not even a nutritional diet plan discussed to prevent things escalating further? There was a window of opportunity before the surgery was carried out to try alternative non-surgical treatments.

(See Appendices for alternate treatment options not presented)

(See Appendices for a history of why surgeons lie in order to obtain consent)

The HDC investigation notes confirm a breach of the Code and the surgeon, as legally required, provides no treatment options. Nor was it disclosed to the patient the direct risks of surgery, such as bleeding, or the resulting risk of a blood transfusion:

• Surgeon “advised (the HDC) that he recommended Ms A have a (laparoscopic) cholecystectomy “as the only proven and gold standard treatment of symptomatic gallstone disease”. He stated that other possible treatment options were not discussed as no other treatment is recommended in fit patients with symptomatic gallstones”

Doing nothing and offering no alternative non-surgical treatment options could be considered as guaranteeing a further client for surgery, and is a failure to provide a duty of care to the patient. This is a breach of Right 4(4), ‘Every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of the consumer.’

There is no evidence presented that the risks of the side effects, likely to affect the quality of life of the patient, were discussed in regards to the surgery. Furthermore, nothing was documented in the Nelson Marlborough DHB informed consent and patient handout out information guide. Consent was not legally obtained and a criminal offence occurred.

Cholecystectomy is associated with several physiological changes in the upper gastrointestinal tract which may account for the persistence of symptoms or the development of new symptoms after gallbladder removal. The cholecyst sphincter of Oddi reflex, cholecyst-antral reflex, and cholecyst-oesophagal reflexes are all disrupted and some local upper gastrointestinal hormonal changes also occur after cholecystectomy. Thus, there is an increased incidence of gastritis, alkaline duodene gastric reflux and gastro-oesophageal reflux after cholecystectomy, all of which may be the basis for postcholecystectomy symptoms. Symptoms occur in about 5 to 40 percent of patients who undergo cholecystectomy, and can be transient, persistent or lifelong. The chronic condition is diagnosed in approximately 10% of postcholecystectomy cases (See Appendices for full details of side effects affecting quality of life)

There is no evidence presented that confirm the major risks of heavy bleeding, as a result blood transfusions being discussed by the surgeon, with the patient. This breach was also confirmed by the HDC:

Investigation notes:

• “Dr C noted that he does not routinely discuss the (risks of bleeding resulting is) use of blood transfusions with patients undergoing a laparoscopic cholecystectomy”
• “I accept that if Dr C had talked to Ms A about the risks and options relevant to her treatment refusal, she may indeed have decided to proceed, and it would not have been unreasonable to do so. Had that occurred, Ms A would have been making an informed choice; without this information she was denied that ”  (This is a breach of patients’ Right 6(2); and Right 7(1))

 (See Appendices for more information on the risks of bleeding resulting in blood transfusions)

More unanswered questions:

Question 1: Was consent obtained illegally because of the non–disclosure of the risks of bleeding, or the risk of blood transfusion? Also, was there deliberate concealment of the true nature of the risks of the procedure and a breach of the Code, namely Right 6(2)?

“Dr C stated: “I always indicate that the laparoscopic surgery bleeding is usually not an issue, a couple of [teaspoons] of blood is sometimes quite a lot. We very seldom have major issues with bleeding.”

However, another injured patient by the same surgeon by the , same procedures, advised that their informed consent process, and subsequent risk disclosure went like this:

The surgeon told a patient: “that the laparoscopic (keyhole) surgery to remove her gallbladder was straightforward and the chances of anything going wrong were less than being hit by a bus.”

NOTE: The statistical odds of being hit by a bus in a major transport city like London are 1/10 million.  Naturally, the patient then provided consent.

 Sadly, post operation the patient awoke to find that during surgery her bile duct had been damaged. The surgeon then went on to kill this patient and one other as a result of uncontrollable bleeding.

Note: European Union issued guidelines for using words to convey risk; they pegged the word “rare” to a risk of 1 in 1,000 to 1 in 10,000.So there is no medical study known that will back these risk disclosure statements given to patients by this surgeon . As such a breach of the Code most likely took place for this patient and another that was injured .

Note: Family members looked into obtaining the consent forms for this patient, detailing the surgery risks.  According to the NMDHB, they are legally allowed to remove these from patient records and as a result they were unavailable.

Question 2: Why weren’t other pervious patients contacted to verify this key testimony, a relatively simple task?

 A lot of evidence provided to the HDC in this particular case was non-collaborated “hearsay” between the surgeon and the deceased, The above testimony would have confirmed fraud and possibly saved the life of the next patient, if there was a proper investigation by the HDC.

Question 3a:  How can the brochure with details of the procedure be used for informed consent when it is void of key information?

We are told Ms A was given a brochure with further information about laparoscopic gallbladder surgery, including details of the procedure, its risks, alternatives, and the recovery process.

Yet the document is completely void of side effects and alternative treatment options, and as such, breaches the Code, Right 6(2). Quite clearly, this right states that deception cannot be used to obtain consent. As such, consent was not legally obtained from the patient. The hospital is also backing the surgeon’s standard practice of offering no alternative treatment options, whatsoever. Most concerning, is that every consent obtained by the Nelson Marlborough DHB is obtained illegally.

(See link: More information about the fake informed consent documents void of key information, never disclosed by the Nelson Marlborough DHB)

Question 3b: How could the surgeon be cleared of any wrongdoing, when they failed to provide informed consent and did not disclose the risks to patient?

The Informed consent documents do, however, clearly state risk of bleeding resulting in requirement for blood transfusion. According to the HDC, a patient has received this information when the surgeon supposedly advises them. Compare this to a patient who always carries with her a laminated directive stating that no blood products are to be used on her person.  Would they not respond, or make mention of this, during the two consultations with the surgeon discussing risks and obtaining consent, as testified by the surgeon?

Who is telling the truth? Was consent legally obtained? Were the risks disclosed?

(See Appendices for medical information about the risks of bleeding during this procedure)

Question 4: Why would the hospital later go on to remove from Ms A’s clinical records, signed informed consent documentation?

It was advised to family members when requests were made for informed consent information that this patient’s information was unavailable. Furthermore, this information has been removed even though a medical council investigation is still in progress. (May 2018)

Question 5a: Is there a civil conspiracy between the NMDHB and the HDC in place to obstruct justice?

The handling of this case once again confirms the HDC’s unwritten policy of ensuring surgeon breaches of the Code; never see the light of day. This is a continuation of protecting negligent medical practitioners and not holding them accountable, as they should, under the interpretation of the legally enforceable Code of Rights found in the HDC Act.

During the course of this HDC investigation the Nelson Marlborough DHB knew about two other serious injuries but never disclosed this to the HDC. This is mentioned in the published investigation # 12HDC0144.

“In 2010, Dr C commenced employment at the Hospital. NMDHB advised that the first adverse incident relating to Dr C that came to its attention was the death of a patient in early 2011, owing to a postoperative haemorrhage following an open cholecystectomy that had been converted from a laparoscopic procedure. At the time of the internal investigation of that case, NMDHB became aware of two cases of common bile duct injury during laparoscopic cholecystectomies performed by Dr C, which had occurred in late 2010 and early 2011”

Did the Nelson Marlborough DHB deliberately withhold this information from the HDC investigation? If these serious injuries had been disclosed by the Nelson Marlborough DHB, to the HDC, in the investigation of the first patient, would this have not influenced the outcome of other investigations? Would a ‘free pass’ for the surgeon occur? Or, instead, would there be a different ruling, resulting in a stand down with significant retraining, as seen with previous HDC investigation outcomes (see #04hdc07920).

If action were taken, would the second patient’s death occur just a few months after this investigation was completed?

Or, was the HDC actually advised of the two other serious injuries by the Nelson Marlborough DHB during this investigation and choose to conceal them as not being relevant? If so, this could be construed as concealing the truth and protecting the surgeon in order to give them a ‘free pass’. Arguably, the HDC becomes an accessory to the fact and can be held culpable for the death of the second patient because of their failure to investigate the case in an open and transparent manner. The HDC are therefore also responsible for concealing breaches and permitting a pattern of harm, putting patient safety put at risk.

Question 5b: Why did the Nelson Marlborough DHB not respond with any further comment to the provisional report?

 This is unusual for any HDC investigation, specifically due to employers being vicariously liable under Section 72(2) of the Health and Disability Commissioner Act 1994 (the Act) for any breach of the Code by an employee. Under Section 72(5) of the Act it is a defence for an employing authority to prove that it took such steps as were reasonably practicable to prevent the act or omission of employees that breached the Code.

There was no response by the NMBHD, to the HDC finding, that a specifically identified hospital procedure, of attending a “time out’ meeting was not followed by the surgeon.  At this meeting key information should have been discussed not to use blood products on the patient and this would have stopped the procedure and saved the patient’s life.

Was the reason for Nelson Marlborough DHB not participating the fact they had become aware of two other serious bile duct injury incidents raised by the clinical director? The surgeon had to be stood down from laparoscopic cholecystectomies and an independent review of his performance with implemented supervision and education. At the time, this would not reflect well in any investigation.

Question 6: Why did the HDC refuse to investigation complaint concerns?

Statement put to the HDC by the family of the patient: “Mr and Mrs B (parents) consider that Dr C’s statement that “[Hospital 1] is not the place to fiddle with vascular bleeding” implies that he was “an amateur” who felt unsure of what he was doing and was not taking their daughter’s complications seriously. They consider that Dr C should have immediately arranged for her transfer rather than re-operating”.

This statement has real merit, as the next patient’s death occurred in eerily similar circumstances as a result of uncontrolled bleeding from injury. This could have been prevented if the HDC investigated the original incident properly and found concerns with Dr C’s skill set and critical thinking. This first case alone should have been a huge red flag, serving as a warning to the HDC to restrict the practice of this surgeon.

(See investigation 12HDC01488 case, second patient death,)

Additional factors:

• The surgeon’s CV overstates their actual experience.
• The lack of experienced surgical supervision oversight by the NMBHB goes against what was required by the Medical Council of New Zealand (MCNZ) for the surgeon’s registration and employment. This was required before the surgeon could go near a patient with a scalpel.

 Investigation 12HDC01488 case notes:

• “Dr C stated to NMDHB that in New Zealand he had encountered a far greater number of unexpectedly difficult cases than he was used to. He attributed this to the greater degree of obesity in the younger, predominantly female, population compared to that which he had experienced overseas”
• ”Prior to coming to New Zealand, his surgery always involved assistants with varying degrees of surgical training, either consultant colleagues or registrars. He noted that there were no registrars at the Hospital”
• “Overseas his surgery always involved assistants with varying degrees of surgical training, either consultant colleagues or registrars“
• An expert advised on the second surgery: “ but I can not ignore the fact that in his CV he claims to have been a course director for [a relevant] teaching programme and was involved in trauma surgery at his previous role as Head of the Divisions of General, Vascular and Thoracic surgery at [an overseas hospital]”
• There were requirements by the Medical Council of New Zealand (MCNZ) for registration and employment at the NMDHB. Specifically, the surgeon was employed with the following requirements indicating he was of ‘lesser experience ‘and NOT a senior surgeon, as advised to the police and the HDC. The surgeon had conditions to be:
  • “Under the onsite supervision of consultant general surgeon Dr D”; and
  • “Off-site supervision of a consultant general surgeon”

Question 7: Did the surgeon, and others involved, truly not know that the hospital did not routinely keep the required alternative blood products, namely recombinant factor VII?

 Did the surgeon have knowledge or did they simply assume it was available. It is known to be an expensive alternative. This would call in to question the truthfulness of the surgeon and single out their culpability. The surgeon claims they were not advised at any time (hearsay), and did not see the directive when reading the notes (also hearsay).

It is also a very important question not asked of the subcontracted Anaesthetist, when he also knew blood products were not available at the hospital at the time.

Question 8a:  Was there a lack of critical thinking?

The time from being made aware of the product not being available, through to the time of re-operation was less than the time it would take to order and fly the product from the main hospital. This was ignored; all whilst knowing the risk to the patient’s life was very serious.

Alternatively, they could have had the patient flown to the main hospital, a 1.5-hour journey, once they were advised of the bleeding and the impossibility of being able to provide a blood transfusion. Also, let’s not forget the requirement, stipulated by the MCNZ, for an experienced surgeon to be able to take over the operation, was NOT currently present.

Furthermore, there were two other injured patients, not disclosed to the HDC at the time of investigation that had to previously be transported to the Christchurch DHB for specialist corrective surgery. By now, the surgeon would be accustomed to injured patients being sent away!

The patient would be alive to this day if either of these actions taken place.

The question must also be asked why would a surgeon even consider re-operating on a bleeding issue with no possibility of providing a transfusion?

If there was lack of discernible leadership, co-ordination and critical thinking in the clinical team treating the patient post-operatively, and a lack of support offered by senior supervising surgeons, this demonstrates a systemic level failure by the Nelson Marlborough DHB to provide services with reasonable care and skill, and is a breach of Right 4(1) of the Code.

Question 10: Why was the surgeon (employee) continuing to operate with no supervision, as stipulated by the Medical Council of New Zealand as a condition for registration and employment by the Nelson Marlborough DHB? 

Specifically, the surgeon was employed with the following requirements indicating he was of ‘lesser experience ‘and NOT a senior surgeon, as advised to the Police and the HDC. The surgeon had conditions to operate:

• “Under the onsite supervision of consultant general surgeon Dr D”; and
• “Off-site supervision of a consultant general surgeon”

Question 11: Was the anaesthetist used as a scapegoat?

 The subcontracted employee, not affiliated to the Nelson Marlborough DHB, appears to be used as the surgeon’s scapegoat for not representing the patient’s directive and not ensuring that the surgeon understood this risks of his first of two attempted procedures. All this took place remembering that the ‘time out’ meeting with the surgeon did not occur due to the surgeon’s not-attendance, which is a mandatory requirement before proceeding with ANY surgery.

The Nelson Marlborough DHB internal procedures stated that consent for the use of blood products was required to be obtained by the Anaesthetist, which was not done due to incorrectly believing the risk was below 1%. When in fact, the risk sat more realistically between 1-10%. Also, the DHB noted the surgeon would still not have been alerted to this fact as his documentation was completed first and the second page requiring the consent of blood product was completed second, by the Anaesthetist.

On first look, these are paper-thin arguments, which seem to point to the Anaesthetist being used as a scapegoat.

Question 12: Why could the cause, or location of the bleeding, not be identified in the investigation, nor be identified by the surgeon, nor appear in the outcome from an autopsy report?

If the bleeding injury to the liver region were caused during the laparoscopic cholecystectomy, would this not confirm sub-standard skills of the surgeon? Emphasising their need for retraining. Or, would the fact that the bleeding was not picked up expose negligence on the part of the surgeon?

6. References

1. Patients’ perception of the adequacy of informed consent: a pilot study of elective general surgical patients in Auckland. https://researchspace.auckland.ac.nz/bitstream/handle/2292/4640/12658314.pdf?sequence=1
2. https://www.sages.org/publications/patient-information/patient-information-for-laparoscopic-gallbladder-removal-cholecystectomy-from-sages/
3. Suuronen, S., Kivivuori, A., Tuimala, J., & Paajanen, H. (2015). Bleeding complications in cholecystectomy: a register study of over 22 000 cholecystectomies in Finland. BMC Surgery, 15, 97. http://doi.org/10.1186/s12893-015-0085-2
4. https://www.stuff.co.nz/the-press/news/68423552/im-lucky-to-be-alive-says-former-patient-of-under-fire-surgeon
5. http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=11443184
6. http://www.stuff.co.nz/national/health/8083329/Family-still-waiting-for-answers-after-death
7. http://www.stuff.co.nz/national/health/10639363/Ex-Jehovahs-Witness-bled-to-death-after-surgery
8. https://www.stuff.co.nz/national/health/64038267/refusing-blood-transfusions-could-prove-to-be-fatal
9. https://www.radionz.co.nz/news/national/122971/patient-deaths-could-have-been-avoided

7. Appendices

Timeline of both fatalities:

• In 2010, the Medical Council of New Zealand (MCNZ) note the surgeon is registered within a special purpose scope of practice to work as a specialist in general surgery at the DHB under the onsite supervision of consultant general surgeon Dr D, and offsite supervision of a consultant general surgeon.
• It was not disclosed to the HDC that two patients, who were operated on in late 2010 and early 2011, were transferred to another hospital with common bile duct injures.
• In early 2011, the first patient died following a post-operative haemorrhage following an open cholecystectomy performed.
• The NMDHB requested that Dr C cease all laparoscopic surgery, while a supervision and education package was put in place. Following the review, and professional advice from his peers on his surgical technique, he resumed performing laparoscopic cholecystectomies.
• In early 2012, a patient suffered a diathermy injury during a laparoscopic cholecystectomy performed by Dr C. Dr C was then stood down from all laparoscopic cholecystectomy surgery pending an MCNZ performance assessment committee (PAC) review
• It was during this period of stand-down that Dr C conducted the “open” surgery on another patient who subsequently also dies from uncontrollable bleeding.

More about bleeding:

A risk greater than 1%, as mandated by the Medical Council of New Zealand, must be disclosed to the patient:

“Risk include bleeding, wound infection, hernias, blood clots, or heart problems. Unintended injury to adjacent structures such as the common bile duct, colon, or small intestine may occur and may require another surgical procedure to repair it. Bile leakage into the abdomen from the tubular channels leading from the liver to the intestine may rarely occur.

The risk of bleeding and risk of transfusion reported as high as 1.3% and even higher for Open Cholecystectomy, 13%

Register data included 17175 Laparoscopic Cholecystectomy,s (LC’s)  and 4942 Open Cholecystectomy (OC’s) , s. In the LC group, 1.3 % of the patients received red blood cell (RBC) transfusion compared to 13 % of the patients in the OC group 

Suuronen, S., Kivivuori, A., Tuimala, J., & Paajanen, H. (2015). Bleeding complications in cholecystectomy: a register study of over 22 000 cholecystectomies in Finland. BMC Surgery, 15, 97. http://doi.org/10.1186/s12893-015-0085-2

Doctors’ own medical studies confirm dishonesty in place:

One 2015 study found up to 27 % of anaesthesiologists and 7 % of surgeons admitted to misrepresenting the truth to each other at least once a month regarding a number of factors that can influence perioperative care. The justifications reported typically involved concerns around the adverse consequences of being truthful; in particular, paternalistic concerns about disclosing truthful information to a colleague who might not understand or who would then demand unreasonable steps. Such concerns were the drivers of intentional misrepresentation much more often than worries about personal blame, chastisement or legal consequences.

Nurok, M., Lee, Y., Ma, Y., Kirwan, A., Wynia, M., & Segal, S. (2015). Are surgeons and anaesthesiologists lying to each other or gaming the system? A national random sample survey about “truth-telling practices” in the perioperative setting in the United States. Patient Safety in Surgery, 9, 34. http://doi.org/10.1186/s13037-015-0080-7

Comprehensive and reputable medical studies confirm post complications include:

The Postcholecystectomy Syndrome (PCS): is a heterogeneous group of diseases and symptoms presenting following gallbladder removal. Symptoms occur in about 5 to 40 percent of patients who undergo cholecystectomy, and can be transient, persistent or lifelong. The chronic condition is diagnosed in approximately 10% of postcholecystectomy cases.

Post-cholecystectomy Syndrome may include: 

• Diarrhoeaas a troublesome problem range from 9 to 12% of which bile acid malabsorption (BAM), 65% of these patients.
• Depression, anxiety disordersoccurring in 0.9%-3.0% of patients
• Bile (duodenogastric) refluxoccurring in 20%-30% of patients.  Likely damage attributable to chronic bile exposure post-cholecystectomy includes:
  • cellular damage to esophagogastric junction
  • bile induced Gastroesophageal Mucosal Injury (Protective barrier that constrains the acidic reflux)
  • increase the incidence of gastric and esophageal cancer
• Sphincter of Oddi dysfunction (SOD) is seen in 1% of patients after cholecystectomy, but in 14%-23% of patients with the post-cholecystectomy syndrome
• increased Body Mass Index (weight gain) with metabolic syndrome, gastritis, liposoluble vitamin deficiency. Cholecystectomy can have nutritional and metabolic consequences and in the long-term

The cholecyst sphincter of Oddi reflex, cholecyst-antral reflex, and cholecyst-oesophagal reflexes are all disrupted and some local upper gastrointestinal hormonal changes also occur after cholecystectomy. Thus, there is an increased incidence of gastritis, alkaline duodene gastric reflux and gastro-oesophageal reflux after cholecystectomy, all of which may be the basis for postcholecystectomy symptoms.”

The onset of symptoms may range from 2 days to 25 years.  There may also be gender-specific risk factors for developing symptoms after cholecystectomy. In one study, the incidence of recurrent symptoms among female patients was 43%, compared to 28% of male patients.”

Patients with cholecystectomy had more comorbidities, particularly chronic fatigue syndrome, fibromyalgia, depression, and anxiety. Postcholecystectomy gastroparesis patients had increased health care utilization and had a worse quality of life.

Postcholecystectomy Syndrome in more detail

Absence of the gallbladder leads to development of functional biliary hypertension and dilatation of common bile duct and the common hepatic duct. The dilatation of right and left hepatic ducts may be formed within 3-5 years after cholecystectomy. Functional hypertension in the common bile duct leads to development of functional hypertension in Wirsung’s pancreatic duct accompanied by chronic pancreatitis symptoms.

During this period in some patients this is accompanied by chronic pancreatitis progression, dysfunction of the sphincter of Oddi and duodeno-gastral reflux. Duodeno-gastral reflux causes the development of atrophic (bile-acid-depen­dent) antral gastritis . After cholecystectomy 40% to 60% of patients suffer from dyspeptic disorders, 5% to 40% from pains of different localizations. Up to 70% of patients show symptoms of chronic “bland” intrahepatic cholestasis, chronic cholestatic hepatitis and compensatory bile-acid-dependent apoptosis of hepatocytes. In some of cholecystectomized patients with high concentration of hydrophobic hepatotoxic co-cancerogenic deoxycholic bile acid in serum and/or feces high risk of the colon cancer is found.

Not disclosed to patients, specialist medical opinion and studies list the following expected risks, side effects, diseases, syndromes and conditions after the removal of the gallbladder and its function. The majority of these problems are not accepted by the HDC as a risk and are blocked from disclosure to patients during the informed consent process, or advised during post-operative follow-ups.

They are but not exclusive to:

Anatomy	Etiology
Biliary track	Biliary injury Cholangitis Choledochoduodenal fistula Choledocholithiasis Clip migration / Inaccurate clip placement Dyskinesia Nonspecific dilatation or hypertension Obstruction Strictures Stump cholelithiasis Adhesions Cyst Dilation without obstruction Fistula Hypertension or nonspecific dilation Malignancy and cholangiocarcinoma Trauma
Bone	Arthritis
Colon	Adhesions; incisional hernia; irritable bowel diseaseConstipationDiarrhoea Incisional hernia
Duodenum	AdhesionsDuodenal diverticulaIrritable bowel disease Peptic ulcer disease Perforation
Esophagus	AchalasiaAerophagiaDiaphragmatic hernia Esophagitis Hiatal hernia
Gallbladder and cystic Duct remnant	InflammationLeakMirizzi’s syndrome Mucocele Neuroma (Amputation ), suture granuloma Residual or reformed gallbladder Stump cholelithiasis
Liver	Chronic idiopathic jaundiceCirrhosisCyst Dubin-Johnson syndrome Fatty liver; hepatitis; cirrhosis; idiopathic jaundice Gilbert disease Hepatitis Hydrohepatosis Liver abscess Sclerosing cholangitis
Nerve	Intercostal lesionsIntercostal neuralgiaNeuroma Neurosis Psychic tension or anxiety Spinal nerve lesions Sympathetic imbalance
Pancreas	Benign tumorsFunctional pancreatic sphincter disorderPancreatic cysts Pancreatic stone Pancreatitis Stone Tumors
Periampullary	PapillomaSphincter of Oddi dysfunction (Functional biliary sphincter disorder); spasm; hypertrophyspasm; hypertrophySphincter of Oddi stricture Stricture
Small bowel	AdhesionsAdhesions; incisional hernia; irritable bowel diseaseIncisional hernia Irritable bowel disease
Stomach	Bile gastritisPeptic ulcer disease
Subcutaneous tissue	AbscessHematoma
Vascular	Coronary anginaInjury to hepatic artery, portal vein (pseudoaneurysm, portal vein thrombosis)Intestinal angina Mesenteric ischemia
Miscellaneous	Dropped GallstonesParasitic infestation (Ascariasis)Thermal injury Trocar site hernia
Other	AnxietyBacteria overgrowth in the stomachBarrett’s oesophagusBezoars Bile Acid Malabsorption Bile Reflux Bloating Celiac Disease Cramps Decrease in bile secretion Depression Diabetes Dumping of bile Syndrome Foreign bodies, including gallstones and surgical clips Gas Gastroparesis GERD Reflux Heartburn Irritable Bowel Syndrome Nausea Pain – right upper abdomen Pain – shoulders and abdomen Thyrotoxicosis Weight gain Weight loss

Evidence based medical studies confirming statistically significant increased risk of cancer following cholecystectomy, required by law but never disclosed by doctors during the informed consent process listed as:

Anatomy	Etiology
Other Biliary tract Liver Colon Esophagus Stomach Liver Liver Pancreas Periampullary Other	Adrenal cancer Ampulla of Vater cancer Cholangiocarcinoma cancer Colorectal cancer (Colon / Bowl) Esophageal cancer Gastric cancer Hepatocellular carcinoma cancer Liver cancers Pancreatic cancer Periampullary cancer Smallintestine carcinoid cancer

Source references:

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