Cosmetic surgery patient safety to be regulated for the first time in NSW

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Safety standards for cosmetic surgery patients will be radically improved with the billion-dollar industry set to be regulated for the first time.

The new regulations published on Friday follow a litany of complaints from patients including those whose lives have been put at risk during routine cosmetic surgery procedures.

The NSW government has strengthened laws regulating the cosmetic surgery industry to provide greater safeguards for patients.

Amy Rickhuss is taken from The Cosmetic Institute to Westmead Hospital. Amy Rickhuss is taken from The Cosmetic Institute to Westmead Hospital. Photo: Webcam-NT

The Australian Society of Plastic Surgeons vice president Gazi Hussain said the NSW regulation was a long-overdue win for patient safety.

“We urge other State Governments to follow New South Wales’ lead,” Dr Hussain said.

A new class of cosmetic surgery has been created under the Private Health Facilities Act. The new regulation means any facility that carries out cosmetic surgery procedures including breast enlargement surgery, tummy tucks, liposuction and facial implants, will for the first time be subject to strict licensing standards that apply to private health facilities.

Krystle Morgan, whose lung was punctured during a routine breast enlargement procedure at The Cosmetic Institute in Bondi in September 2014, welcomed the changes, saying they should have been introduced “a long time ago”.

Amy Rickhuss went into cardiac arrest during a breast enlargement operation. Amy Rickhuss went into cardiac arrest during a breast enlargement operation. Photo: Supplied

“It’s about time they are doing that,” she said. “Any change to make it safer is a good thing.”

Ms Morgan, now 34, was one of six patients who had serious complications during surgery at The Cosmetic Institute’s Bondi and Parramatta facilities and whose cases were the subject of a NSW Health Care Complaints Commission investigation.

Krystle Morgan's lung was punctured during a routine cosmetic surgery at The Cosmetic Institute in Bondi in 2014. Krystle Morgan’s lung was punctured during a routine cosmetic surgery at The Cosmetic Institute in Bondi in 2014. Photo: Greg Totman

The Commission in April found the patients were given unsafe doses of a cocktail of sedative drugs that made them unconscious without their consent.

It found the six patients suffered life-threatening complications and 33 were exposed to questionable levels of sedation at The Cosmetic Institute.

In April, the Australian Society of Plastic Surgeons said the HCCC findings were “shocking” and had highlighted the urgent need for governments to regulate the cosmetic surgery industry.

Dr Hussain said the NSW regulation was a long-overdue win for patient safety and will help ensure people undergoing cosmetic surgery procedures are given the same protections as patients undergoing any other type of invasive of surgery.

“We have long been concerned by the gap in quality and safety systems surrounding cosmetic surgery which has meant some patients were being administered high volume local anaesthesia in unlicensed premises which have been able to fly under the radar in terms of accreditation and audit,” he said.

The NSW amendment applies to surgical procedures other than dental that are intended to change a person’s appearance and which involve general, epidural, spinal or major regional anaesthetic or unconscious sedation.

Facilities that carry out these procedures will have nine months to become properly licensed under the Private Health Facilities Act and Regulation.

Health Minister Jillian Skinner said a NSW Health discussion paper informed the changes which will “ensure a safer regulatory environment for patients undergoing selected cosmetic surgical procedures”.

“Reports of significant adverse health outcomes for some patients has led to growing public concern over high-risk practices by some operators,” Mrs Skinner said.

New Medical Board of Australia guidelines for medical practitioners who perform cosmetic surgery will also come into effect from October 1 and include cooling off periods for patients.

Merrilyn Walton, the professor of Medical Education, Patient Safety at the University of Sydney, referred a series of incidents involving life-threatening cosmetic surgery procedures to the Health Care Complaints Commission, which she once headed.

She welcomes the new regulations which she has urged successive governments to introduce for 17 years.

“This is great,” she said. “It means patients can trust the environment they are in complies with minimum standards to ensure their safety.

“Now the doctors will be required to report their adverse events and apply mandated safety standards.

“There will be oversight by the NSW Ministry of Health.”

Earlier this week Fairfax Media reported that a push by payday lenders into loans for elective and cosmetic surgery could also lead to a rise in risky procedures and put people’s health at risk. Lenders are looking for new revenue streams following a crackdown into the sector by the corporate regulator.

Fairfax Media has reported at least four cases involving the emergency transfer of patients from The Cosmetic Institute to hospital.

They included the case of Amy Rickhuss who went into cardiac arrest during cosmetic surgery at The Cosmetic Institute’s Parramatta clinic on January 30, 2015.

She was rushed to Westmead Hospital’s emergency unit and early reports from The Cosmetic Institute indicated that she “had a reaction to the anaesthetic”.

Fairfax Media later revealed Ms Rickhuss, 21, who survived the life-threatening experience, was given Intralipid, a drug most commonly used to treat an overdose of local anaesthetic.

Fairfax Media also revealed a 22-year-old woman from Mordialloc in Victoria was rushed to St Vincent’s Hospital emergency unit from The Cosmetic Institute’s Bondi clinic after having serious complications during a breast enlargement procedure.

The HCCC report said two patients flatlined while having breast enlargements at The Cosmetic Institute clinics and needed to be resuscitated, another suffered a seizure, and a third went into ventricular tachycardia and needed to be resuscitated.

Patients were routinely given adrenalin with a cocktail of sedative drugs “well above the accepted upper limit of safe dosage”, and “an overdose of adrenalin is likely to have contributed to some of the adverse outcomes seen in patients”, the report says.

The Cosmetic Institute had marketed breast augmentations under conscious sedation, using the local anaesthetic. But patients were given a combination of sedative drugs that in many cases “were consistent with general anaesthesia” and “in excess of the safe upper limit recommended for these drugs”.

The Cosmetic Institute general manager Andrew Gill said the clinics had taken steps to address the issues, but disputed the HCCC’s finding that the clinics had put the health and safety of the public at risk.

All TCI surgeries in NSW were now performed at Concord Private Hospital under deep sedation or general anaesthetic, Mr Gill said in a statement to Fairfax Media in April.

“TCI is also reviewing consent procedures and documentation to ensure that patients are fully aware of the level of sedation under which they will placed,” he said.