They made the appeal in the wake of the rising number of women with faulty implants across the Kingdom. These women found out about the health risk only after consulting plastic surgeons to verify the type of silicone used in the surgery.
Dr. Ma’moun Daghestani, consultant cosmetic surgeon at the National Guard Hospital, said there was a health warning issued as early as in April 2010 about the existence of contaminated silicone gel used for breast implants and that they could rupture and leak industrial-grade silicone.
He said one Saudi plastic surgery clinic was found using suspect silicone implants.
“A French company produced and exported the product in violation of international safety rules and standards. The French government decided to liquidate the company when it found out about the illegal act in April 2010. The government also warned all consumers to stop using it,” he said, adding that the international media took up the matter only recently when Interpol intervened in the matter last month.
Interpol issued on Dec. 23 a “red notice” seeking the arrest of Frenchman Jean-Claude Mas, founder of the now bankrupt Poly Implant Prothese (PIP) company, which was at the center of a health scare involving faulty breast implants. On the same day, France’s health ministry advised 30,000 women with breast implants made by PIP to have them removed, saying that while there is no proven cancer risk, they could rupture and cause health problems. France also offered to pay for their surgery.
Daghestani said PIP did not have any authorized agents in the Kingdom. The product was sold in the local market through its sole agent in the UAE.
“Saudi hospitals and clinics did not have any ties with the French company except one clinic. This clinic used to import the PIP product not directly from the company but through its UAE agent,” he said.
Daghestani noted several Saudi women approached him to remove breast implants made by PIP. “I had successfully removed breast implants from many women and there were no health complications reported from them later. The breast implant used by the company is made from industrial rather than medical quality silicone,” he said adding that this was detected only after exporting it to several countries.
According to Daghestani, it was not clear whether the product would cause cancer. He said most women do not have any idea about the type of silicone used in breast implants. “Therefore, we are forced to carry out surgery as the only way to find out,” he said.
Daghestani urged all Saudi women who had breast implants to consult their surgeon to find out if the silicone used was safe. “Most of my colleagues at the National Guard Hospital and myself frequently receive several calls and messages seeking clarifications about this matter. Several women who underwent breast implant surgeries also approached us,” he said. He said most breast implants available in the market are safe to use and adhere to international health standards and quality.
Dr. Hashim Bolkhi, a cosmetic consultant, said that there is no facility to carry out laboratory tests on silicone products entering the Kingdom. “Any silicone product can enter the Saudi market provided that they have a license from the US Food and Drug Administration (FDA). It is unfortunate that such products enter the market without any laboratory tests,” he said.
Bolkhi said several Saudi women who had faulty breast implants are now uncertain whether to carry out removal surgery or not. “Some of them underwent a second surgery to have implants removed while others are yet to make up their mind,” he said.
According to Bolkhi, Saudi Arabia does not have a specific law that compels women to register their names in case they underwent any breast implant surgery. “Such a law would help the authorities to get access to them and collect relevant information with regard to the hospital from where they underwent the surgery. The French authorities benefit from such a law that helped them to collect all the information about the women with breast implants,” he said adding that industrial silicone may cause serious health risks such as inflammation or blood poisoning.
Dr. Saleh Al-Tayar, deputy executive president for medical equipment and products at the Saudi Food and Drug Authority (SFDA), said the contaminated silicone did not enter the Kingdom through any of its entry points. Speaking to Asharq Al-Awsat newspaper, he said SFDA has urged all the hospitals and health clinics in the Kingdom to ensure that they are free of this harmful product.
“We have alerted our outlets at all entry points to the Kingdom to be vigilant. We also issued a public statement through the media urging those women who underwent such procedures to approach their surgeons to ensure that they are free from any health risks,” he said.
It is noteworthy that PIP, once the world’s third largest breast implant company supplying more than 100,000 implants a year, was shut down and its products banned in 2010 after it was revealed to have been using the non-authorized silicon gel. Tens of thousands of women belonging to more than 65 countries in Europe and South America such as France, Britain, Italy, Spain, Portugal, Brazil, Argentina, Columbia and Venezuela have had implants made by PIP. The implants are filled with an unapproved non-medical grade silicone believed to be made for mattresses and there have been reports that the protective barriers are faulty.
