FOR THIS CASE WE ARE ONLY LOOKING FOR COMMENTS FROM PLASTIC SURGEONS. NO COMMENTS FROM OTHER SPECIALISTS, PLEASE.
37 year old female one year post placement of silicone implants presents to dermatologist for evaluation and treatment of keloid scars from implants. Dermatologist’s assessment Hypertrophic scar and performed Intralesional Kenalog injection. Two months later, dermatologist performed second Intralesional Kenalog injection.
Patient started to notice a change in her left breast. Three months later, patient returned to her plastic surgeon who ordered MRI for suspected rupture. MRI confirmed the rupture of the left implant. Plastic surgeon notes: “The patient states she noticed a change in her left breast shape following an injection by a dermatologist”
Plastic surgeon diagnosed bilateral capsular contraction Grade II and left ruptured implant, bilateral hypertrophic scars, breast asymmetry, acquired deformity and distortion of the right and left breast. Surgery was performed with included bilateral implant exchange with capsulectomy. She developed seroma and had exploration one week later.
The scars that she initially saw the dermatologist for have greatly worsened due to the need for the additional surgeries all within 1 ½ years. The patient has pain and loss of sensation in the breast.
The case was reviewed by dermatologist who opined if the injection caused the rupture then the procedure was improperly performed and dermatologist committed malpractice. The issue the plastic surgeon would have to address is what was the cause of the rupture? Was it caused by the injection?
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Do you believe there might have been medical error?
The dermatologist should not have been injecting with sharp needles in proximity to the breast implant. Silicone breast implant rupture at one year post op would be extremely rare under any circumstances except for direct trauma. The temporal relationship between the injections in the area with what I would expect is a sharp needle and the diagnosis of implant rupture speaks for itself absent any other explanation. A careful and detailed review of the entire patient’s history and medical record would be required for complete evaluation. There is some potential for yellow flags. An examination of both the explanted breast prostheses would be critical. Needle puncture is certainly different from a large tear in the shell. An explanation of why BOTH implant units needed to be replaced if only one was ruptured should be documented and the findings of the plastic surgeon at re-op is critical.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Hard to explain a reason for breast implant rupture at one year post op absent another explanation.
What makes you a good expert for this case?
I have been a board certified plastic surgeon for over forty years with much experience in breast implants. . I present well and know the difference between fact and opinion.
How often do you encounter cases similar to this one in your practice?
I see several cases of breast implant rupture annually over many years. In this specific case, i have never encountered a case where a dermatologist felt comfortable injecting scars connected to an underlying breast implant.
Do you believe there might have been medical error?
If the dermatologist caused the rupture this would be a medical error. The dermatologist causing the rupture can be proven or disproven by 1) temporal relationship of breast getting smaller/implant deflating within days/weeks of kenalog injection; 2) intraoperative examination of the implant during explantation showing needle hole in area of scar; and 3) post-explantation examination of the implant by the manufacturer confirming a needle caused the rupture as opposed to normal wear and tear, fold, or other cause (It is standard of care to send implants back to the manufacturer when they prematurely rupture in order to receive warranty assistance with costs of surgery and new implants. The manufacturer performs a detailed examination including microscopy to determine the exact cause of rupture. Patients have been known to rupture their own implants with a needle in order to receive this warranty money so implant manufacturers specifically look for needle holes). Why did the patient not go to her plastic surgeon or any plastic surgeon for treatment of her hypertrophic surgical scar? Did the dermatologist offer/suggest for the patient to have her injection performed by her or any plastic surgeon (who is more qualified to safely stick needle around implants)? If dermatologist did not try to refer to plastic surgeon this was a medical error. Did the dermatologist inform the patient of a risk of implant rupture by his needle prior to the procedure? If not, this was a medical error failing to provide informed consent. Capsular contracture, hypertrophic scars, asymmetry, seroma, and loss of sensation are all known risks of breast augmentation with implants and do not suggest medical error on part of the dermatologist or plastic surgeon and are not related to the kenalog injection.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
I believe there might have been causation as evidenced by the implant/breast becoming problematic weeks to months following the dermatologist injection. If the dermatologist did not suggest/offer the patient to have her injection done by a plastic surgeon or did not inform her of the risk of rupture I believe there would have been causation. A plastic surgeon is less likely to make the medical error of puncturing the implant with a needle whereas a dermatologist is more likely.
What makes you a good expert for this case?
Because I just gave you all the right answers above.
How often do you encounter cases similar to this one in your practice?
Ive never seen a dermatologist be stupid enough to stick a needle into an implant. I frequently encounter ruptured breast implants. I frequently encounter needle holes in implants as plastic surgeons/I intentionally rupture implants with a needle weeks prior to selectively removing/replacing implants to help the patient decide if she still wants/needs the implants and if she needs a lift after removal of implants. I have seen needle holes in implants that I or my assistant caused during surgery.
Do you believe there might have been medical error?
Based on the history, the Kenalog injections caused the implant rupture. Normally injecting keloid scars requires the injection to be intradermal. The implant can usually be moved out of the way to minimize puncturing the implant. However, if the skin is thin, then puncturing the implant is possible. The patient needs to be informed of this prior to injection because it is a medical risk. If the patient is informed of this risk prior to injection, then there is no medical negligence on the part of the physician. It can and does happen.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
The patient did not have any issues with volume prior to the injection. After the injection, the implant was noted to decrease in volume only. Thus establishing a cause and effect.
What makes you a good expert for this case?
I have performed over 6000 breast augmentations and also inject keloids on a regular basis.
How often do you encounter cases similar to this one in your practice?
I encounter cases similar to this every couple of years. It is not common to have the implant ruptured by an injection. Bu, it does happen.
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