DOCTORS have been warned to stop using a medical filler gel after a patient who was injected with it developed unusual lumps in her breasts. The problem was discovered a year after the woman was treated with Aqualift Dermal Filler during a breast enhancement procedure.
The Health Sciences Authority (HSA) sent an e-mail to doctors on Dec 7 as a precautionary measure. It told them to stop using existing stocks of the dermal filler immediately and monitor patients who had been treated with it. It also told Celeste, the company that distributes the product here, to recall it from the market.
HSA was informed of the woman’s case late last month. It called it “a probable adverse event that could be linked to the use of Aqualift Dermal Filler”. It said investigations to determine the cause are ongoing, and declined to name the patient or say where she was treated. Aqualift Dermal Filler is used to reconstruct human tissue. It is a hydrophilic gel, which means it readily absorbs moisture, and is made of a synthetic fibre, or polyamide. It is manufactured in the Ukraine by the National Medical Technologies Centre.
The dermal filler has been available worldwide since 2004, but an application to register it in Singapore on Sept 28 was rejected due to the lack of clinical data to support its long-term safety and effectiveness in tissue reconstruction. Since Aug 10, all high-risk medical products supplied in Singapore must be registered with HSA. But most of the Aqualift Dermal Filler here is believed to have been brought in before this date.
Dr Vincent Yeow, president of the Singapore Association of Plastic Surgeons, said dermal fillers in general come with high risk complications. The top side effects from their use are swelling, inflammation, abnormal redness of the skin and lumps, according to research by the Food and Drug Administration in the United States.
Dr Yeow, who also heads the department of plastic, reconstructive and aesthetic surgery at KK Women’s and Children’s Hospital, added other side effects include formation of nodules on the skin. “It also increases the difficulties in screening for breast tumours and cancers,” he said. This is because it can create false positives, where tests indicate cancer, but later turn out to be false alarms.
HSA said last night: “Aqualift Dermal Filler is an unregistered and unlisted Class C Medical Device, and the company cannot import or supply it locally after Aug 10, 2010. It is to be noted that the patient was treated before this date.”