Concerns Over Unauthorized Macrolane Injections in Cosmetic Surgery

Administering Macrolane directly to the cheeks without the patient's consent?

My sister went to a medical aesthetics clinic on December 3, 2009, to purchase a treatment for cheek augmentation and tear trough filling.
The treatment consisted of SubQ 2 c.c.
x 2 and Touch 0.5 c.c.
x 1, which was administered.
However, three days after the injection, the wound still felt painful, and she developed cellulitis.
After taking a large amount of antibiotics on her own, the wound gradually improved, but about three months later, her face became asymmetrical, with hard lumps appearing in the tear troughs, and her cheeks became sunken again.
From a distance, her cheekbones appeared prominent, but up close, her facial proportions seemed off.
There were hard lumps under the tear troughs that appeared slightly white.
After reporting this to the clinic, they expressed willingness to provide a touch-up and asked my sister to return for a follow-up.
On February 3, 2010, at around 3 PM, I accompanied my sister to the clinic.
After the doctor examined her, he explained how the injection would be performed.
At that time, the nurse brought out a vial of SubQ 2 c.c.
for me to confirm.
However, when it was time to start the injection, they kept trying to send me away.
By the time I was allowed back in, the injection had already been administered, and it turned out to be Macrolane (not yet on the market).
I would like to ask if my sister's face will have any issues.

Xiao Huihui, 30~39 year old female. Ask Date: 2010/02/25

Dr. Lu Daokuan reply Plastic Surgery

Basically, legal and approved medications should be used domestically.
Of course, unapproved drugs in the market cannot be completely eliminated, possibly due to lower costs.
Whether your sister's face has issues may not be absolutely related to legality; after all, her first treatment went well, didn't it? How could there be an infection? It is best to return for follow-up visits to confirm the treatment's effectiveness.

Reply Date: 2010/02/25

More Info

The situation you described regarding your sister's experience with unauthorized Macrolane injections raises several important concerns about the safety and legality of cosmetic procedures. Macrolane, a hyaluronic acid-based filler, is not approved for use in many countries, including the United States, which means that its safety and efficacy have not been thoroughly evaluated by regulatory bodies such as the FDA. This lack of approval can lead to significant risks for patients, particularly when administered without proper consent or oversight.

Firstly, the initial injection your sister received resulted in complications, including pain and a subsequent infection (cellulitis). This indicates that the procedure was not performed under optimal conditions, which raises questions about the clinic's standards of care. Infections following cosmetic procedures can lead to serious complications, including scarring, tissue necrosis, or even systemic infections if not treated promptly and effectively. The fact that your sister had to self-medicate with antibiotics further suggests a lack of appropriate medical supervision.

After three months, your sister experienced additional issues, such as asymmetry in her facial features and the formation of hard lumps in the tear trough area. These complications are concerning and may indicate that the filler was not properly integrated into the tissue or that it has migrated from the original injection site. The appearance of white lumps could suggest the formation of granulomas, which are inflammatory reactions to foreign substances, in this case, the injected filler.

When your sister returned to the clinic for a follow-up, the administration of Macrolane without her knowledge or consent is particularly alarming. Consent is a fundamental ethical principle in medical practice, and patients have the right to be fully informed about the substances being injected into their bodies. The fact that the clinic proceeded with an unapproved product without her explicit consent raises serious ethical and legal issues.

In terms of potential long-term effects, the use of unauthorized fillers can lead to unpredictable outcomes. Patients may experience chronic inflammation, allergic reactions, or even the need for surgical intervention to remove or correct the filler. Additionally, the psychological impact of such complications can be significant, leading to anxiety, depression, or body image issues.

Given these concerns, it is crucial for your sister to seek a second opinion from a qualified medical professional, preferably a board-certified dermatologist or plastic surgeon with experience in cosmetic procedures. They can assess her current condition, recommend appropriate treatments, and discuss options for correcting any complications arising from the unauthorized injections.
Furthermore, it is advisable for your sister to document her experiences and consider reporting the clinic to relevant medical boards or regulatory authorities. This can help protect other potential patients from undergoing similar experiences and hold the clinic accountable for their actions.

In summary, your sister's situation highlights the importance of ensuring that cosmetic procedures are performed by qualified professionals using approved products. Patients should always be informed about the substances being used and should never feel pressured or coerced into undergoing treatments without their full consent.

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