Failure to obtain informed consent
On June 30, a 63-year-old woman came to her plastic surgeon with an MRI report of ruptured implants in both of her breasts.
Documentation included the patient’s wishes to have silicone removed from her body. The patient’s medical history included a diagnosis of cancer of the left breast with a subsequent mastectomy performed by the plastic surgeon. Initially the surgery included a latissimus dorsi flap of the left breast with subsequent silicone breast implants inserted in both breasts followed by chemotherapy. The plastic surgeon followed her closely throughout recovery.
Documentation of the June 30 appointment included the patient’s desire for reconstruction of her left breast with a contralateral superior pedicle transverse rectus abdominis myocutaneous (TRAM) flap. It was also discussed that the ruptured implants would be removed from both breasts and that a mastopexy would be performed on the right breast in attempt to match the size and shape of her new left breast. The documentation did not mention the possibility of using another implant on the right side to achieve symmetry.
On October 9, the patient returned for a preoperative visit with the plastic surgeon. In that meeting, they discussed that the ruptured implants would be removed from both breasts, a mastopexy performed on the right side, and a TRAM performed on her left side. The patient signed a comprehensive consent form that included replacement of the right implant. The form was signed and initialed by the patient and witnessed by one of the physician’s staff members.
Hospital documents — including the written informed consent — did not mention that a saline implant was to be inserted on the right side. There was also no mention of a saline implant in the plastic surgeon's order to obtain the operative permit. The anesthesia and nursing preoperative records also did not mention a plan to replace the right implant.
The patient was taken to the OR on October 17 where she underwent removal of both ruptured silicone implants with a left TRAM breast reconstruction and a right mastopexy followed by capsulectomy and placement of right saline-filled implant with a volume of 225 cc. The patient’s hospital recovery was uneventful. Initial postoperative office documentation stated that the surgery performed was a left TRAM flap, right mastopexy, and removal of bilateral breast implants without replacements.
The patient visited the plastic surgeon on numerous occasions for nearly seven months. During this time, she experienced some wound healing problems in both breasts and developed a seroma of the abdomen that required multiple aspirations. The patient stated that she did not know that an implant was inserted on the right side until her postoperative visit on December 15. During this visit she recalled the conversation she had with the plastic surgeon on June 30 in which she expressed her desire to not have any more silicone in her body. The plastic surgeon last saw the patient on May 18 of the following year.
At no time during the patient’s course of care did she complain about the postoperative situation. Significant improvement was achieved with regard to symmetry of her breasts after the revisionary procedures. While the implant used in the surgery was a saline implant, it had a silicone shell. The patient alleged that the plastic surgeon placed a saline breast implant in her right breast without her consent; the implant causes her worry and anxiety; and future surgery is necessary to remove the implant.
A lawsuit was filed against the plastic surgeon, alleging failure to obtain proper consent and comply with the patient’s wishes.
One defense expert reported that the patient underwent an appropriate preoperative evaluation. After the discovery that her implants had ruptured, appropriate options were discussed. The defense expert also believed that the patient had some knowledge that she was to undergo replacement with a saline implant. The patient signed a written surgical consent for the implant to be replaced with a right side implant, which was a separate document. Also, once the patient became aware that she had a saline implant, the plastic surgeon told her it would be simple to remove. However, the patient did not move forward with that request.
Both experts stated that the postoperative care and the surgical outcome were strengths in this case. However, defense experts also commented on the communication breakdown between the plastic surgeon and the patient. There was no informed consent discussion documentation about the plans for surgery to remove the right silicone gel implant and replace it with a saline implant.
There was no plaintiff’s expert testimony filed.
This was settled on behalf of the plastic surgeon.
Risk management considerations
Clear communication is central to a physician-patient relationship. In this case, a disparity was evident in the informed consent documentation from physician to patient, and physician to hospital.
Should a liability claim occur, a physician has a better defense when documenting in the medical record:
- the informed consent discussion for the procedure;
- a statement confirming that the patient’s questions were answered; and
- a statement that it is your opinion, as the physician, that the patient fully comprehends the procedure to be performed, along with the associated risks.
The law places the duty to obtain informed consent upon the physician and it is non-delegable. The fact that a hospital or nurse voluntarily undertakes the duty to obtain informed consent does not relieve the physician of the duty, but merely adds additional parties that may be subject to legal liability. Nevertheless, if a nurse is assigned the task of informing the patient and obtaining the signature, the physician still remains responsible to see that it is getting done properly. (1)
1. Texas Medical Association. Informed Consent. February 2012. Available at http://texmed.org/Template.aspx?id=6049. Accessed on March 28, 2014. Member login required.