SA slow to recall booby boobs

While Britain rushes to extract dodgy breast implants from some of its 40 000 women fitted with them, South Africa lags far behind in protecting its citizens from faulty medical devices.

Chief of the South African Medical Device Industry Association, Tanya Vogt, said high-risk devices, such as silicone for breast enlargements, metal stems, screws and pins for knee and hip replacements, artificial eyes and stents used to keep arteries open, "are not regulated".

She said these devices were considered high risk because "if something goes wrong with the device, the patient could die. French company Poly Implant Prothese has been forced to recall its implants after the French regulatory authority found that there may be an increased chance of ruptures, and that the implants were filled with an unapproved industrial grade silicone.

In the UK, 40 000 women who have PIP breast implants will be contacted and "offered further procedures subject to clinical need". The Australian government has set up a 24-hour information line for its 5 000 women who have had PIP implants in the past decade.

Dr Chris Snijman of the Association of Plastic and Reconstructive Surgeons of Southern Africa said no local plastic surgeons were fitting the dodgy implants at the moment. But they were used before 2006. He said the company supplying the product was only in South Africa for a short space of time and while there were no official statistics on hand, at least 11 surgeons were using the implants prior to 2006.

Samed has been lobbying for quality control laws of medical devices since the industry body was formed in 1985. Hip replacement devices imported from Austria and Czechoslovakia in the early 1990s began to break one to three years after they were inserted, instead of the 15 years they were meant to last.

The products were quickly discontinued. But 20 years on, medical device regulation is still not in place. In July last year, draft regulations were published for comment, but Vogt said nothing had yet been heard from the Department of Health.

Harriet McLea: The Times, 12 January 2012