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  INDUSTRY INDUCED COMPLICATIONS

All the time the surgeon is responsible for complications. This traditional view to the events must be changed. Here is an example:

 

This coated visorb manufactured by CP Medical, Portland , OR USA, purchased the 2 months by Shmaisani hospital was given to me and I performed 11 surgeries with this material. Among patients was a doctor and another one is the father of the doctor. This material caused disastrous events to all my eleven patients. The usual clinical picture starts not immediately, but the third or fourth postoperative day, when a subcutaneous massive serous fluid start to exudate in massive quantity, that you start to think that CSF leak took place.  The father of the doctor to whom  the surgery was undertaken for OPLL was kept in hospital for three weeks with the thought that CSK leak is coming out and he was covered with vancomycin and mannitol. The patient was kept  in a position to decrease the flow of the proposed CSF leak. During that time the wound was open, but the subcuticular material was in place. Accidentally , I removed this material and within three days all the reactions subsided and the patient was discharged. You can see the operative video record. You can also see the video record of patient with LCS, how required debridement and suturing by nylon, after what the wound healed normal. Even the doctor with 2 cm incision for PLD still complaining of dehiscence and mostly she will require debridement under G.A for this 2 cm length incision.  The company has no address to contact with and the dealers with such materials are a loose number to take the responsibility for such events. In case if some authorized  personality follow this event , this material must be immediately withdrawn from the market. Thanks God that the series of patients were understandable and cooperative. But thousands of JDs  were spent to correct these sequelae. Later the FDA was involved with this problem and complete report was given  and they promised to resolve the problem.

The material issued in 08-April-2005

ENT INDUCED COMPLICATIONS

Case presentation:

A young 25 years old patient was operated 2 months ago, after what he got persistent CSF leak. The patient was seen 05-11-2004 with mild meningism, lethargic, without fever  and no considerable neurologic deficit. The patient performed MRI with contrast 05-11-2004. It showed a huge defect at the right cribriform plate  with air filling the entire ventricular system with massive dilatation of the right lateral ventricle, which was reaching the base of anterior fossa.

The patient was operated 06-November-2004: Through subfrontal approach right side, repair of the dural defect and sealing of the base by muscle and bone graft was performed. Video available. It is very rare to see such complication, that reaching the ventricular system, making wide communication between the ventricular system and the sinuses.

 

1.Intraoperative complications not related with the surgery.

1. Intraoperative CVA of the left cerebral hemisphere during discectomy for PCD C4-5 and C5-6 with fusion.

2.Postsurgery not related complications/events:

1. Acute necrotizing pancreatitis
2. Massive pulmonary embolism. Case 17-January-2008
3. Drug Induced Complications:

There is a material of five patients with unknown to me complications 4 of them fatal and one survived after laparatomy. It was impossible to know what is going on, until the last case gave the clue for the reason of these complications.  The common dominator between all these case, that all of them during the last 2 months, that they received dexametasone  16 mg three times a day for minimum 2 days. After analyzing the cause, it became clear, that Decadron was replaced by dexametasone of Egyptian brand ( EIPICO); which was used the last 2 months in the hospital, where my activities are going on.

Here the list of patients in retrospective retrograde chronological order:

1. Medulloblastoma in young 36 year woman.
2. A young chap with dorsal neurenteric cyst with massive GI bleeding requiring laparatomy.
3. A case after decompressive cervical coporectomy  complicated by acute necrotizing pancreatitis.
4. Recurrent brain-stem infarction with edema after successful endarterectomy.
5. Recurrent craniopharyngioma with huge intraventricular extension.

During the 26 year experience, I have the ability to predict the possible complications in certain pathologies, but with introduction of various medications from new companies with unknown standards, the possibilities of complications is becoming wide and the prediction for complication is loosing the clear picture. Thanks to God that I work in one place, and I have the ability to retrospectively catch the problem, but may be there are thousands of patient paying their life for corrupted medical companies.

This part issued 14-August-2006

Contrast agents used in MRI investigations.

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A patient performed more than 10 times over the years MRI investigations using contrast media without complications. The center was using Magnovist. At this time he was given MultiHans and this could cost to him his life due to rapid allergic anaphylactic shock which was treated immediately.

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Another known complication could have place is nephrogenic systemic fibrosis.

 

 

2. Surgical products causing complications during surgery:

1: BloodSTOP ix:  This product was offered for me to use it in critically vascular tumors to decrease bleeding, but in the contrary, it caused many problems and in the end result it was the source for further bleeding. For more details please refer to the presentation case.  25-December-2009.

2. Tsunamimedical vertebroplasty bone cement  slipping to the intraossal veins of the near by vertebrae and the epidural veins causing vascular compromise to the roots. For demonstration, Click here|

3. Cefazolin causing hypocoagulation with delayed oozing of the clean surgical wound, necessitating delayed discharge of the patients. After revision of the directories of infection control, we were advised to start and continue Cefazolin I/V Jordanian production, to prevent infection in clean neurosurgical patients. All the patients showed the same picture of continuous oozing of the wound and delayed discharge of the patients from the hospital. After stopping the product, the wounds were clean and we could discharge the patients. The cases were during July 2014: Case one, case two, and case three. This item was added 07-July-2014.

3.Postsurgery related complications/events:

1. CSF pocket after removal of right S3 Tarlov cyst.
2. Immediate postoperative CSF leak.  
3. PEEK Satellite Nucleus Replacement Sphere with discitis. 
4. Hydr'Os bone graft injected to the intradiscal space, which gradually dissipated causing inflammatory reactions with events mimicking swollen root, then ganglion of the lateral facet and triggering recurrence of huge extrusion.

5. Postoperative tracheostomy related complication.

4.Bad surgeon related complications:

1. Unstable cervical spine after supposed to be discectomy of C6-7.

So as to have digital data registering the complications in evolution and escalation, we introduced the best in the world ISIS Highline Inomed IOM. It started 30-August-2007 and became in common use for all surgeries since that time.

4. MRI Induced complications:


Figure: 1,2,3 showing the wheelchair stuck to the MRI  from deferent angles. This is the result of negligence of the technical staff and disruption of the regulations, allowing non certified personnel entering the dangerous areas. This happened in facility in one of the respected hospitals in Amman, Jordan 12-July-2014.

 

5. Medical Error Is Third Leading Cause of Death After Heart Disease and Cancer  in USA.

Published in Medscape Neurology 04-May-2016.

 

 

 


 

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