Public Warning under s94A of the Health Care Complaints Act - Unsafe Practices involving subdermal implants inserted for “extreme” body modification purposes

16 Apr 2018

PUBLIC WARNING UNDER S94A OF THE HEALTH CARE COMPLAINTS ACT 1993: UNSAFE PRACTICES INVOLVING SUBDERMAL IMPLANTS INSERTED FOR “EXTREME” BODY MODIFICATION PURPOSES

The NSW Health Care Complaints Commission is concerned about complaints regarding surgical procedures involving the insertion of subdermal implants for “extreme” body modification purposes and the risks to the health and safety of consumers undergoing these procedures.

There is a growing trend of consumers in NSW seeking a range of procedures (whether medical or not) to alter their appearance.

Subdermal implants used for “extreme” body modification purposes come in a variety of shapes including horns, snowflakes, skulls, crowns or other objects and are generally made from silicone.

Unlike more traditional body art or “body modification” procedures, such as tattooing and piercing, the insertion of subdermal implants involves surgery.

These procedures involve incisions being made with a scalpel through the skin and subcutaneous tissue, instruments being used to open the pocket in which the implant will be inserted and suturing of the incision site.

As such, these procedures involve serious health risks and complications, which include:

Infection – this may arise as a result of poor infection control standards, poor sterilisation of equipment or the implant itself, or could arise after the procedure due to a number of factors including an exposed wound or poor aftercare.  Infection carries real risks and in some cases may result in sepsis.  In the most serious cases, sepsis can be fatal.

Nerve damage – this may result from the procedure being poorly executed or from placement of the implant itself which might interfere with nerve function or other internal structures, such as muscles, tendons and ligaments.

Other complications include allergic reactions to the materials used and/or the body rejecting the implant itself. These complications may require the consumer to seek urgent medical attention, to undergo revision procedures and may leave the consumer with scar tissue or other permanent damage.

What should consumers do to protect themselves?

The Commission strongly urges consumers seeking the insertion of subdermal implants for body modification purposes to be vigilant in their research prior to proceeding. In all cases the following factors should be considered before committing to the procedure:

1. Is the procedure being performed by a practitioner who is appropriately qualified, experienced and accredited?

Generally, implant procedures carried out for "cosmetic" rather than medical purposes (e.g. breast, facial or calf implant procedures) are carried out by registered medical practitioners in licensed health facilities.

However, there are persons in the “body modification” industry who offer services involving the insertion of subdermal implants who are not medically trained and are not suitably qualified to carry out surgical procedures.

A person may be qualified to perform skin penetration procedures, including tattooing and piercing, yet not be suitably trained and qualified to carry out body implant procedures.

Further, the body implant procedure itself is painful and generally anaesthetics would be used for these types of procedures. Such medications are restricted substances and carry risks if prescribed or administered inappropriately. Unapproved imported anaesthetic agents are of unknown quality, safety and efficacy.

It is illegal for a person who is not a registered health practitioner or otherwise authorised under the Poisons and Therapeutic Goods Act 1966 to supply or administer a restricted substance to another person.

2. Is the facility appropriately registered, infection controlled and equipped?

Subdermal implant procedures carried out by tattoo or piercing artists may be carried out in non-sterile premises, including tattoo parlours. Such premises must be notified to local councils as carrying out skin penetration procedures and comply with infection control standards in accordance with the Public Health Regulation 2012 (NSW).

However, this in no way guarantees that the measures are adequate to ensure the health and safety of consumers undergoing a subdermal implant procedure.

3. Are the implants safe?

The subdermal implants use in “extreme” body modification are not subject to the same stringent research and testing as other types of implants, such as medical grade silicone breast implants.

Subdermal implants used by tattooists and others providing these services are not approved medical devices in Australia.  As they are not approved by the Therapeutic Goods Administration (TGA), the quality and safety of the material being placed beneath your skin in these types of procedures cannot be guaranteed.

4. Have you sought medical advice?

Consumers should not entertain undergoing a body implant procedure without seeking the advice of their doctor.  It is important to be informed of the risks and complications involved in undergoing such procedures and steps that can be taken by the consumer to protect themselves from injury or other adverse outcomes.

A medical practitioner will also consider making a referral to an appropriate mental health professional in circumstances where a consumer may be suffering from Body Dysmorphic Disorder (BDD) or other condition which is contributing to their desire to alter their appearance.

Consumers should exercise caution in accepting the claims of any person who claims to be qualified in carrying out subdermal implant or other surgical procedure who cannot demonstrate that they are a registered medical practitioner with relevant surgical training and qualifications.

If you have undergone a body implant procedure and have not been reviewed by a medical practitioner, you should speak with your doctor.

If you hold concerns that the wound or area around the implant is infected, you should seek urgent medical attention.

Why is this warning being issued?

The Commission has received complaints about body modification services being provided in NSW, including procedures involving the insertion of subdermal implants for “extreme” body modification purposes.

The issues raised in the complaints received include:

  • Whether the person(s) carrying out these procedures are suitably trained and qualified to be providing these services
  • Whether these services are being carried out in a sterile and appropriately equipped setting
  • Whether the services are being provided in a safe and ethical manner
  • Whether consumers receiving these services are receiving appropriate follow up care, and
  • Whether scheduled medications are being used for the purpose of the procedures in breach of the Poisons and Therapeutic Goods Act 1966, and
  • Whether consumers are being urged to inform their treating medical practitioner of the services they are receiving

The Commission is investigating these complaints and inquiries are presently ongoing.    

The Commission has serious concerns that non-registered health practitioners are carrying out surgical procedures to “alter” the appearance of consumers:

  • without being appropriately trained or qualified, and/or
  • failing to do so in a safe and ethical manner.

 

Further Information

For further information, contact the Executive Officer of the Health Care Complaints Commission, on 9219 7444 or send an email to media@hccc.nsw.gov.au.

The information in this media release is correct at the time of publication. Orders may change; for example, conditions may no longer apply. For current information regarding the status of a registered health practitioner, including any conditions that currently apply, please check the National Register at www.ahpra.gov.au.