Exempt from public disclosure pursuant to offline a. § 13 cf. PAA. § 13, first paragraph. 1
The public demands for transparency in individual cases are handled through that anyone can request access to individual documents, based on publicly available mailing lists.
Norwegian Board of Health has decided to issue a warning pursuant to the Health Personnel § 56 first paragraph. We have concluded that you have violated the acceptability requirements of the same Act § 4 by your health care to XXXXXX .
You can appeal the decision within three – 3 – weeks of receiving this letter.
Procedural process
Norwegian Board of Health received by letter dated XXXXXX from the County of XXXXXX submitted a supervision about your activities of physicians. Audit case concerns your health care to patient XXXXXX (hereinafter the patient).
We oriented you by letter dated XXXXXX that we would consider giving you a warning. You stated you to this by letter dated XXXXXX and the letter was forwarded to us as the appropriate authority of the County of XXXXXX.
Other supervisory matters
County of XXXXXX In a letter dated XXXXXX, concluded a supervision towards you where they found that you had broken acceptability requirements of the Health § 4 by giving a patient deficient monitoring in the postoperative course after a breast enlargement engagement in XXXXXX.
We also have now received two other supervisory matters for the Norwegian Board of Health. We will inform you in more detail how these will be considered in separate letters.
The subject matter
You are a medical doctor in XXXXXX and received authorization in Norway XXXXXX, HPR no. XXXXXX. You became a specialist in plastic surgery in XXXXXX. At the time of the incident were you plastic surgeon at XXXXXX XXXXXX in.
Norwegian Board has considered the matter on the basis of the documents you’ve got submitted earlier in the proceedings. Below is a discussion of the factors that have had an impact on our rating.
The sequence of events XXXXXX – XXXXXX on XXXXXX
The patient, who is from XXXXXX, contacted via internet XXXXXX XXXXXX with desire facelifts and breast lift. This emerges from your medical record from the XXXXXX. The initial consultation with the patient, who was also the preoperative assessment, carried out as a video consultation over Skype this date. In journal note you write about the patient that “ she is happy with the size of their breasts, but is unsure if she should have a small prosthetic to give a slightly more rounded shape to the breasts.” You write that the patient is wearing a size C / D cup bra. In your review you write that she does not need enlarging. It appears from the record note that she is informed by you about chest lifted, risks and complications, and the postoperative course and that it has already been sent out written information about the procedure. It appears, however, does not explicitly what the content of the oral information is, and in the written information “General information concerning the risks and complications” is necrosis / necrosis not mentioned. You write that the patient can decide if she wants implants in the breasts When appearing for the operation, and that she will combine operations (breast lift and facelift).
“Annex 3″, dated XXXXXX, which both contains declaration completed by the patient and evaluation filled out by you, it appears that the patient has XXXXXX, previously undergone cesarean XXXXXX and takes Alvedon and Ibuprofen as regular medication. By your assessment states that she has a JM (jugulum / Mamilla) distance of 30 cm and ptosis (hanging) of 10 cm.
The patient was operated by you XXXXXX. Of operation description it does not appear if you have any assistant during surgery. You write that the patient has moderate sized breasts with heng (ptosis) and that she would like to enlarge your breasts and make breast lift on both sides. You write that it is selected prosthesis size of 275cc, but it is not evident how / you’ve arrived at this prosthesis size or who have chosen size (you, patient and you jointly or patient alone).
Furthermore, in the operation description you write that you “ draws an anchor-section with a new expected location of the nipple at 20 cm distance JM”. You describe the drawing area for deepithelialisering with upward based stem and that you “Promises a central upward based stem from the crease to the upper edge of the breast. Dissects saw a subfaciell pocket to the top of the chest. “ It is further stated by operation description that you inserts the prosthesis and folds the distal end of the stem around the prosthesis and fix this to the pectoralis. You adapts hereinafter glandular tissue and areola mobilizes to its new location. You then close the glandular tissue, fat tissue and skin. It does not appear operational description type of dentures you have used (manufacturer) or compresses / instruments votes at the end of the operation.
In the next journal note of you from the XXXXXX says that the patient comes to the first postoperative control. You write that she has developed since last necrosis right nipple with total necrosis of the entire areolakomplekset. You describe how you cut away all the necrotic tissue, purifies and packages wounded and appointments with the patient that she should change wound similarly 2 times daily at home. It appears from the record note that adding the following schedule for further treatment: You will try to get granulation tissue in the wound bed and then put on a skin graft. When this may have attached itself will proceed with the reconstruction of a new nipple. Should it prove that it takes too long to get granulation tissue, you might need to remove the prosthesis and revise chest properly before skin grafting. You will then set a new prosthesis in place before you reconstruct a new nipple. You do not write the note if you have had contact with the patient during the period of operation of the first control. You write that the patient is taking antibiotics prophylactically, but you do not write who has decreed this.
In the medical record of the XXXXXX type that the patient comes to the assessment conducted to determine whether it has come granulation tissue in the wound bed. It says there is unfortunately still necrosis and that removed part. It says further that it is unclear how much tissue to be abolished and that this should be considered under general anesthesia. You write that the patient be set up to an hour for this, and that she is informed that you may need to remove the prosthesis if necrosis goes deep enough.
In the next journal note of you from the XXXXXX stated that the patient comes to Debridement under general anesthesia. It says it is planned removal of the whole stalk and partial closure of the wound. You write that you open with a knife and come down to the stalk. You describe the tissue from the sides of the post bleeds fresh, while the stem is somewhat inferior and that you remove the stem completely corresponding to the upper edge of Mamilla. You write that you saw going into the actual prosthesis pocket and that it empties about 150 ml serous fluid therefrom. According to the note, rinse well with chlorhexidine 1%, maketh wave door held in place with two safety pins, adapters skin the post and closing all the wounded. It does not appear note that the implant was removed, and it is not documented that compresses and instruments were checked at the end of the procedure. It appears from the note that the patient has received Azitromax 500 mg x 3 times in three days and that she is put on Xarelto 10 mg x 1 for 10 days for the sake of previous pulmonary embolism, and she gets an agreement on removal of the drain tube for 1 week.
In your medical record from the XXXXXX says that the patient comes to the agreed packing procedure. You write that there still are a number of secretion from bølgedrenet and that you keep the drain. You write that the wound is healed above the chest, but the stitches will sit another week. Then it says that you rinse sårhulen with 1% chlorhexidine until it overflows clean liquid out and that the patient takes in the rinsing syringe and catheter that she will use to replace the wounded. You write that you expect that the drain can be pulled out during the next two weeks. You write that the patient will come to new control after three weeks when you’re back from vacation. It says nothing about any deliberations that you have in relation to the sustained secretion in the drain.
Last note when you register is from the XXXXXX. In this note states that the patient could not meet to control when she had been admitted on XXXXXX XXXXXX in with increasing infection image on the right chest. It says further that it was undertaken further Debridement and excision of necrotic tissue and found a forgotten gauze from previous operation by you. You write that you should make an appointment with the patient to discuss further treatment and compensation for what has happened.
of events during hospitalization at XXXXXX
The patient was evaluated in plastic surgery polyclinic at XXXXXX XXXXXX it. She was two days earlier seen at the emergency room of a doctor from the Department of Plastic Surgery that removed the drain and emptied large amounts of pus. There were also sampled from the wound to the culturing which later showed growth of bacteria. The XXXXXX patient was operated with excision of residual breast tissue. It was found during the procedure a compress full of pus. The patient was discharged the same day. She came to control the XXXXXX where there were good conditions. At the final assessment XXXXXX, they saw that the wound had healed fine, but that there was no breast tissue in the chest.
Your answer to the County dated XXXXXX and the State Board of Health dated XXXXXX
1) Regarding preoperative assessment
In your statement to the Norwegian Board type following about your deliberations as to whether the patient should have prosthesis or not: “ XXXXXX were allowed to decide this” . You also wrote “The surgeon decides never that a patient should have dentures by such an operation and it was not the case with XXXXXX ” Regarding your deliberations in relation to combining operations ( breast surgery and facelifts), type: “The assessment for combining operations were based on the following: if there was indication for procedures in which case the estimated operation time and patient’s general condition” . And later “With a fresh and not smoking patient and estimated operating time to under four hours, reviewing the undersigned combination of surgery to be prudent” .
2) Regarding operation and inventory of pads:
In your statement to the Norwegian Board of Health rewrites operation: “The XXXXXX s S-lift and breast augmentation with lift was undertaken by standard techniques. That she got necrosis on the right nipple was an unexpected and unfortunate event. This was a possible but uncommon complication of this procedure regardless of the technique that was used “. You also write in your answers to the County that you deeply regret that it was forgotten gauze under Debridement, and that this is probably due to a miss in the clinic’s count procedures. You write that in order to avoid similar, you have tightened their already established practice.
3) Regarding the postoperative follow-up:
In your response to the Norwegian Board of Health type of contact with the patient in the postoperative course she did go home the same day as she was operated on, and that she would change bandages a week after surgery. You write that you were in telephone contact with the patient the second postoperative day, and that there was nothing to indicate that not everything went according to plan. You then type the patient took telephone contact when she changed the bandages. She responded that the nipples were dark, especially on the right side, and she wondered what she should do. She was told to change with saline compresses twice daily, and it was agreed new contact two days later. Two days later, she contacted again and she sent picture of the breasts, which showed that the nipple on the right side was darker. You also wrote the following: “This seems possible incipient mamillnekrose and the patient was instructed to continue changing until control with us assessing any measures”. When the patient came to control the XXXXXX it was considered that there was a need for Debridement and the entire Mamilla had to be removed. She got a big innsøkk chest. It was agreed further action and packing procedure and it was considered prudent to let her make sårskiftningene itself. On the agreed control a week later as they require further revision. About the course after Debridement and final inspection of the patient, type the patient were joined bandages, and that she would keep in touch with you through the holidays. The patient called the first week and said that it was difficult to make, dressing home. She was then again urged to use the local clinic. You write in conclusion adheres to the patient that she, without you were contacted by the local doctor, was sent to XXXXXX the XXXXXX where she was admitted to extensive Debridement.
In your statement to the County Governor type bl. a. Commenting upon the event that necrosis of the nipple after a breast lift is a known but rare complication caused by impaired circulation to the nipple. You type “ Is circulation strained want a prosthesis could adversely affect and possibly accentuating circulation problem. This in turn can cause edema in the tissue with an increased risk of necrosis. “ You write on ” When one recognizes a reduction in circulation, you try to improve circulation in an attempt to rescue the nipple. “ You also write that it was made more Debridement when necrosis first was a fact and that the patient at no time was left to itself.
4) Regarding operation method:
In your response to the County writes also that the fact that the operation on the left side was approximately uncomplicated and with a good result confirms that it concerns a complication and not a technical error.
Patient information on the progress XXXXXX – XXXXXX
The patient has spoken out about the incident by letter dated XXXXXX XXXXXX XXXXXX and to the County of XXXXXX. The patient says that she contacted XXXXXX XXXXXX with the question of breast lift and facelift. When the patient is a resident of XXXXXX, suggested to make consultations over Skype. The patient stated that she found this strange and uncomfortable but accepted the Skype consultation. It was agreed that it should be done facelifts and breast lift. She says that it was not until the day of surgery it was decided that it should be entered implants in her breasts and that this was done because you stressed that it would give the best results. The patient stated that she had no possibility to overrule this and that she also received limited information about possible complications of the procedure.
The patient says that she got in touch with you then she would remove bandages on her breasts after a week, the XXXXXX. She was worried about the nipple on the right breast which was dark and discolored she was afraid something was seriously wrong. She was told to change the wounds with saline compresses 2 times daily, but were not asked to come to control with you. She says that she some days later sent photos of her breasts from their mobile to you. She questioned whether it would look like this, but was told she fussed about. She also told to pierce the nipple with a safety pin. She got neither at this connector told to come to control. She says that she therefore went to the packing procedure in emergency and municipal.
The patient states that she was first investigated in you XXXXXX, three weeks after surgery. You responded with the first revision of the wound and presented plans for reconstruction of lost tissue. The patient was totally distraught. She burst into tears at your office and locked himself in the toilet in the office and wept long. Next check the XXXXXX she got a clear feeling that you could not what you did, and that the measure would not help. After the last inspection, when it was sustained secretion from the drain which was placed after the revision, the patient was left to deal with the problems completely even the coming three weeks while the clinic had closed for summer holidays.
Legal basis for assessment
Information in supervision by the case to consider whether you have acted contrary to the requirement of proper business in Health § 4, first paragraph.
The Health § 4, first paragraph and second paragraph reads:
health professionals must perform their work in accordance with the requirements of professional responsibility and diligent care that can be expected based on their qualifications, the nature of work and the situation in general.
Health professionals should abide by their professional qualifications, and shall obtain assistance or refer patients further where necessary and possible. If the patient needs dictate, the profession shall be by collaboration and cooperation with other qualified personnel. Health professionals have an obligation to participate in developing individual plans, when a patient or user is entitled to such a plan for patient and user Rights Act § 2-5.
The Health § 4 is a central provision. The provision requires professional responsibility and diligent care and health professionals’ professional practice.
What is justifiable is determined by an assessment of each case, and how health workers ideally should have acted.
Norwegian Board of Health review
Norwegian Board has considered whether your health care to the patient has been professionally acceptable. We have considered including:
- Your preoperative assessment / review
- Operation Method
- Your postoperative follow-up and treatment of the patient when it tilstøtte complications
Our assessment of your preoperative assessment / report
Proper surgical treatment requires that the operator makes a thorough preoperative assessment. This should be done with the patient in the room. The assessment involves taking a detailed medical history of the patient and make a comprehensive objective examination. History shall include at least familial disposition, previous and current diseases (including past surgeries and complications of these), allergies, medications (taken regularly / on daily bais) and social conditions. Moreover, a plastic surgery medical history include questions that may reveal increased bleeding such as whether the patient has an increased tendency to bruise or have had Prolonged bleeding with tooth extraction or childbirth. The objective evaluation should include an assessment of the area to be operated and other areas relevant to consider before the actual procedure. Thus comes in a plastic surgery practice that one should take necessary measure and evaluate the aspect ratio. One should further consider vevskvalitet, tissue thickness, skin type, any skin diseases and old scarring. When it comes to dentures should be taken measure of the patient’s breasts prior to surgery so you can identify a prosthesis that fits the patient’s preoperative breast size.
You abated one preoperative evaluation of the patient over Skype. You should have made an objective examination with the patient present. We refer among others to you by a Skype consultation had an opportunity to undertake Bust (eg jugulum / Mamilla distance, chest width, ptosis) to assess prosthesis size and / or operating method in advance of surgery. Nor had the opportunity to evaluate many families or consistency of breast tissue. You did not need information for planning intervention in sufficient detail. Norwegian Board also notes that a Skype consultation, where there is a physical distance between patients and counselors, can be uncomfortable for the patient. In this case, the patient had to show off her breasts on display. A Skype contact is also not a good forum to get the necessary doctor / patient contact is desirable before a major surgical intervention, and the special setting may be contributing to that important information about the patient’s health is not getting through. A consultation via Skype may also affect the quality of the information the patient receives by the surgeon, and meaningful information about the operating method, risks and complications may deteriorate. We point out that you did not get ahead in your consultation the patient previously had pulmonary embolism associated with cesarean delivery. You thus did not have prophylactic anticoagulation in connection with the first procedure which lasted about 5 hours. Because this important information was missing, had you not sufficient basis to assess whether it was safe to make a combined operation. The patient initially received prophylactic oral anticoagulants in connection with the next operation (Debridement) with you.
You agreed first on the day of surgery the patient should have admitted dentures. In our opinion should not the decision about which type of surgery the patient should have been made or modified in type interventions have been made on the day of surgery. We show that the insertion of the prosthesis in a breast should be well motivated in relation to the results the patient wants to achieve with surgery and must be discussed thoroughly with the patient. Insertion of prosthesis must also be a joint decision between the patient and surgeon. On the day of surgery, most patients nervous before surgery, and it may be difficult to deal with such decisions. The patient should be guided in their choice of surgery and informed carefully about the pros and cons of the different types of intervention, and the risks and complications associated with the disturbance. In situations where different operating methods are appropriate, the patient should be given ample time to think over what method she wants.
After the State Board of Health assessment should the preoperative assessment has been undertaken as a clinic consultation, not as a Skype consultation and operation method should have been clarified before the day of surgery.
Our assessment of your operating method
The method of surgery should be selected on the basis of the method’s safety (including the method’s safety associated with the individual patient’s anatomical conditions), general security for the patient and the expected aesthetic result. The larger and more substantial the interference was, the greater the risks of complications. An important part of the surgeon’s responsibility to the patient is to facilitate an intervention from the clinical indication. If there are several choices when it comes to method, the surgeon must weigh for and against and then decide which method he / she thinks is best for the individual patient. Then the surgeon must guide the patient and sober setting up the various methods against each other and motivate their choice. Regarding breast lift versus breast lift with prosthesis is the greater risk and higher complication rate associated with the latter procedure. This applies to both short and long term complications. Bleeding risk is increased with increased operation time and larger wounds, the risk of infection increases when it entered foreign, risk of wound dehiscence increases the more tissue is manipulated and stretched and risk of necrosis increases as reduced circulation of tissue (such as breast lift) combined with increased tension in the tissue (as the insertion of prosthesis). Insertion of prosthetic entails moreover risk brystdeformerende capsule formation in the long term. It should therefore substantial reasons to do a combined procedure, and the motivation for this will be that by making a combined intervention can achieve a significantly better result than in outpatient surgery. A combined intervention must be an established method and must not be a random combination of two simple methods.
When reviewing the medical record from Skype consultation stated that you did not think it was due to enter implant on the patient. You type in your review “the breasts she do not magnification,” . Similarly, type the patient’s assessment of itself “ she is happy with the size of their breasts, but is unsure if she should have a small prosthetic to give a slightly more rounded shape to the breasts.” You chose anyway to enter prosthesis. Regarding operating method for breast lifted stated it is not clear what technique you used. You write in standard operation description that you draw up at a McKissok technique, a so-called vertical “bipedichle” technique. However, type the patient’s operation description that you lift a central upward based stem entirely from the fold (understood as submammærfuren) up to the upper edge of the breast.
McKissok is a technique where one must pay particular attention to the width of the patch at depth, as it easily by dissection may happen taper of tag down the pectoralis and important circulation may be lost. The following referenced from Plastic Surgery, Third Edition, 8.1, 152-164. “Five years prior, McKissock modified Strombeck`s horizontal bipedicled technique into a vertical bipedicled technique. This required thinning of the superior and inferior portion of the bipedicled flap two allow folding, and resultingly does not have as much as other perfusion techniques “. As mentioned above, it appears from the operation description that you lift a central upward based stem from the crease to the upper edge of the breast. In order to ensure circulation of a superior stem, should this be superomedial or superolateral as by Orlando or Skoogs techniques. Blood supply to the chest comes from three main sources: medially from perforator from a. internal mammary, laterally from a. thoracalis lateralis and lateral intercostal perforators. Sharing breast tissue is therefore safe while one or more of the vascular axes are preserved. If the superiore stalk is too narrow compromised vascularity from both the medial and lateral axes and vascular risk of developing necrosis increases. If stalk moreover is too long compromised circulation in the lower part of this (intercostal perforator over cut) and the risk of development of necrosis increases further.
By operation description also appears that you placed the nipple on a jugulum / Mamila distance of 20 cm. The preoperative target was 30 cm. Because of the above circulatory conditions, the risk of influence of circulation in the nipple complex depending on how high this raised the length of the stem that is cut increases with altitude to lift it. It is common to set an upper limit of 10 cm for the lifting of the nipple in the case where breast lift can be done without simultaneous insertion of prostheses. When combined lifting and insertion of prosthetic this distance should be reduced. Some plastic surgeons the limit of 4 cm to make a combined intervention (Beale EW et al, Predict Ability in Augmentation Mastopexy. Plast Surg Recontr . 2014; 133; 284-292).
You spent thus a method that have poorer perfusion of the patch than similar methods while undertook a high lift of the nipple and additionally allow the implant. It considered moreover that uncertain whether breast lift with “vertical bipedicled technique” while insertion of prosthesis is an established surgical technique. If the patch you promise only was based superiort there was an increased risk that the circulation was compromised because of the vascular axes were not preserved. After the State Board of Health perception had a hard base with a long jugulum / Mamilla distance a combined intervention (breast lift with implants) where the risk was significantly greater than in outpatient surgery (breast lift) and expected results were not significantly better than in outpatient surgery . In our opinion ought to have made a single intervention.
Our assessment of your post-operative follow-up and treatment of the patient when it tilstøtte complications
surgical patients must be followed in relation to when the Postoperatively expected complications. Postoperative complications divided on this basis into 3 groups. These are: 1) the complications that occur within the first 24 hours after surgery (usually bleeding), 2) complications usually occur within 7 to 10 postoperative days (infection, necrosis, wound dehiscence, etc.) And 3) complications which come late in the course (seroma, kapselskrumpning, atypical scarring etc.). By plastic surgery interventions conducted as outpatient surgery, it is common that, depending on the size of intervention, either considering patient day after surgery or calling the patient and hears his or her situation. The first greater control of the patient should be done after about a week. Here you get important information about healing and incipient necrosis, infection, wound dehiscence, and more. Any deviation from normal healing at this point one must intervene (audit, antibiotics, frequent packing procedure, closer monitoring than planned etc.) This part of opphelingsfasen is particularly important, as intervention by irregularities can limit the damage and are crucial for the outcome after surgery.
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