by Sara Bergmanson, Digital and Social Media Specialist, and
Emma Louise, Risk Management Representative
Presentation
In November 2014, a 53-year-old woman came to a dermatologist for treatment of a mastectomy scar. Her history included right-side breast cancer and right breast reconstruction surgery a year earlier. The reconstruction surgery included an implant and acellular dermal matrix graft of the inferior pole. She had been a patient of the dermatologist for two years.
Physician action
At the appointment, she was evaluated by a physician assistant who advised that her scarring would become less noticeable over time, but corticosteroid injections were a treatment option. The patient was told to follow up in a year.
On March 13, 2015, the patient returned and expressed interest in corticosteroid injections to treat the right-side breast mastectomy scar. The scar had a raised appearance, measuring 13 x 0.8 centimeters, and was described as feeling tender.
The dermatologist identified seven lesions on the right breast and injected each with 40mg/cc of corticosteroid. It was noted in the medical record that the patient was aware of the risks including atrophy and hypopigmentation.
On June 5, 2015, the patient met with her primary care physician after finding bruises and increased rippling of her skin due to the implant. The physician also noticed some deflation of the implant and darkening skin at the bottom of the breast.
Over the next month, the patient’s right breast incision had completely thinned out and the inframammary fold had lost its structure causing the implant to droop down below the inframammary fold.
On August 21, 2015, the patient returned to the dermatologist. She explained that a few weeks after the injection, the scarred area began to flatten and the skin around the scar became a reddish-purple color. After another few weeks, the discoloration expanded and rippling and thinning of the skin occurred.
The dermatologist expressed his belief that the corticosteroid injections migrated outside the scar area causing significant atrophy to the right breast. The scar and atrophy measured 10 x 6 x 0.5 centimeters.
The patient told the dermatologist she consulted with two plastic surgeons, and both recommended a right breast reconstruction. The dermatologist apologized for the complications and agreed that surgical repair would achieve a proper cosmetic result.
They discussed which surgeons had experience with similar complications and subsequent repairs. After the appointment, the patient requested a copy of her medical records and did not return for follow-up.
The patient underwent right breast reconstruction revision on October 25, 2015. A month later, the thin skin area had improved and the mastectomy was adhered to the modified Ryan flap.
A year later, the patient wanted to increase the right-side breast implant due to it being smaller than the left side, but she was advised against it due to concerns with skin quality.
Allegations
A lawsuit was filed against the dermatologist alleging:
- the steroid injection caused healthy breast tissue to atrophy;
- failure to obtain informed consent;
- improper steroid dosage;
- failure to assess patient response; and
- failure to consult with the treating surgeon prior to administering corticosteroid injections.
Additionally, complications from the steroid injections resulted in a second breast reconstruction and possibly a future third. The time off from work for surgery resulted in lost wages and future lost wages if a third reconstruction is needed.
Legal Implications
There were differing opinions among consultants about the appropriate course of treatment in this case. The disagreements mostly centered on questions about the standard of care for scar treatment on a reconstructed breast of a former breast cancer patient, and whether the dermatologist should have consulted the treating plastic surgeon.
The dermatologist documented that the patient was informed about the risks of atrophy and hypopigmentation. However, the patient disputed this. Dermatology consultants said oral consent is standard for this treatment, and patients are only instructed to follow up if problems occur. The patient did not return to the dermatologist for re-evaluation until five months after the corticosteroid injections. If she had returned sooner, it is likely something could have been done before the skin began to atrophy.
Experts for the plaintiff argued that the dermatologist should have consulted with the plastic surgeon and done a smaller test dose first. They expressed that it is common knowledge that mastectomy flaps are thin and vulnerable to corticosteroid injections. Consulting the patient’s treating surgeon would ensure that complicating factors, such as the implant, were identified and addressed before proceeding.
The defense was unable to find supportive medical literature for the dosage the dermatologist used as a starting dose for an intralesional injection. In addition, the manufacturer recommendations were 10mg per 2cc for intralesional injections and 2.5 and 5mg per 2cc for treatment of dermal lesions.
During the case review, it was discovered the patient had a breast revision surgery scheduled before receiving the steroid injection, due to breast asymmetry and some loss of the inframammary fold. However, the revision surgery would not have been as extensive as the revised reconstruction.
Disposition
This case was settled on behalf of the dermatologist.
Risk management considerations
In this case, the plaintiff alleged a lack of informed consent; lack of consultation on treatment options with the plastic surgeon; and inadequate follow-up with the patient.
According to the American Medical Association (AMA), “informed consent occurs when communication between a patient and physician results in the patient’s authorization to undergo a specific medical intervention.” In addition to stating the diagnosis and treatment options, the purpose, burdens, potential risks, and expected benefits of the treatments should be included in discussion. This would also include the potential of ongoing treatment. The conversation and consent decision should be documented in the medical record. (1)
The physician documented a discussion of risks of corticosteroid injection with the patient, specifically that “the risks of atrophy and hypopigmentation were reviewed with the patient.” Consultants who reviewed this case argued that signed informed consent forms were unnecessary if the discussion was documented in the record.
However, the patient claimed that the discussion of risks did not happen. While not required, it may be beneficial for physicians to use written consent forms for any injections or minor procedures with known risks. If developing and using consent forms, include an explicit description of the purpose, expected benefits, potential risks, and potential for ongoing treatment. While the consent issue was not the deciding factor in this case, the use of a consent form may strengthen a physician’s statements regarding whether adequate informed consent was obtained.
Opinions differed on whether the dermatologist should have consulted with the plastic surgeon about the steroid treatment. The consultants agreed upon the risks of atrophy and hypopigmentation, and that mastectomy flaps are thin and vulnerable to corticosteroid injections. Additional risks include hypertrophic scarring, keloids, steroid acne, and capillary dilation. Given the medically complex patient and situation, consulting with the surgeon may have helped both physicians make a more optimal treatment decision. (2)
Another difference in opinion by the consultants was whether to perform a test injection of the corticosteroid to gauge the effects on the scar tissue.
In this case, the patient was instructed to follow up or return to the clinic as needed. However, it is recommended that patients be provided specific instructions (e.g., immediately in case of new symptoms or lack of improvement) for a follow up visit. Providing precautionary instructions, such as to call the office in the event of unexpected reactions or side effects, could reinforce patient accountability to report unexpected symptoms or reactions.
Some state board rules, including those of the Texas Medical Board, note it is the physician’s responsibility to document “the patient’s progress, including response to treatment, change in diagnosis, and patient’s noncompliance” and that the written plan of care must document “specific instructions for follow up.” (3)
The lack of consultation with the treating plastic surgeon before administering the corticosteroid was noted by the consultants as being critical to the outcome of this case. Consulting with the treating plastic surgeon familiar with the patient’s case and documenting this conversation could have supported the dermatologist’s treatment decisions.
Sources
- American Medical Association. Informed consent. American Medical Association: Code of Medical Ethics. Opinion 2.1.1. Available at https://code-medical-ethics.ama-assn.org/ethics-opinions/informed-consent.
Accessed November 29, 2022. - Ogawa, R. The Most Current Algorithms for the Treatment and Prevention of Hypertrophic Scars and Keloids: A 2020 Update of the Algorithms Published 10 Years Ago. Plastic and Reconstructive Surgery: January 2022 - Volume 149 - Issue 1 - p 79e-94e doi: 10.1097/PRS.0000000000008667.
Accessed December 15, 2022. - Texas Medical Board. Texas Administrative Code. Chapter 165, Medical Records. Rule 165.1(6)(D). Available at https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=9&ch=165&rl=1 .
Accessed November 29, 2022.
Emma Louise can be reached at emma-louise@tmlt.org.
