More than 400 Ticas have suspect breast implants

U.S. Food and Drug Administration photo Silicone gel-filled breast implants get special scrutiny in the U.S.

Adolfo Ortiz, vice minister de Salud, estimated Tuesday that more than 400 Costa Rican patients received the foreign Poly Implant Prostheses, more commonly known as PIP. Worldwide hundreds of thousands are believed to have the implants. Ortiz said his calculations were based on figures provided to him by the distributor of the French-made product here in Costa Rican.

This type of breast implant has been at the center of a global controversy after it was discovered to be faulty.

The implants were sold freely in Costa Rica from 2009 until the middle of 2011 when the ministry revoked the product’s health approval in the country, he said. The French enterprise was once one of the largest implant manufacturers in the world until it was found that the implants were more likely to rupture and that many of them were made with industrial-grade silicone rather than medical grade.

Ortiz said the biggest threat from the implants is their likelihood of rupturing, which can cause infection and inflammation at the site of the implant. He said as of Tuesday no such cases of rupture had been reported in the country. But there also exists the widespread fear that the implants can slowly leak the industrial silicone and cause the increased possibility of other health risks, such as cancer.

Ortiz said the accusations of an elevated risk of cancer for women with the implants has not yet been validated. The French health ministry reported through its extensive monitoring study that although several French women with the implants were reported to have developed breast as well as other rare types of cancer such as lymphatic or lung, the correlation of cancer and the implants has not been established and that actually the population of women living with the implants demonstrates cancer rates below the national average.

However the French government health officials as well as other countries such as Venezuela have said they would support women seeking preventative removal of implants. Ortiz said that Costa Rica will not initiate any type of recall or removal for the people living with the implants, but rather suggested monitoring of the implants with regular health check-ups. Some 30,000 French women are believed to have the defective implants.

The British Association of Aesthetic Plastic Surgeons said that the implant’s failure rate due to rupture could be as high as 10 percent and removing them may be the appropriate course of action. The president of the association, Fazel Fatah, in a Dec. 23 press release expressed the opinion that the brunt of the responsibility should lie on those who implanted the risky devices in women.

“We believe there is a moral and ethical obligation on the clinics who performed these operations in the first place to facilitate the removal of the faulty implants for free or at the bare minimum cost,” he was quoted saying on the association’s Web site.

Most of the patients living with the potentially dangerous artificial breasts in Costa Rica received them in the three major hospitals associated with the Caja Costarricense de Seguro Social: Hospitals México, Calderón Guardia and San Juan de Dios. Ortiz said this signified that most people probably had them inserted for reconstructive purposes following an operation for breast cancer rather than for cosmetic reasons.

To a lesser degree, he said eight private health care providers in Costa Rica are known to have administered the PIP implants. It remains unclear if other units were sold illegally or went undocumented by the distributor since the questionable implants began in circulation in 2001. But Ortiz, a physician, said he didn’t think that was the case.

The Poly Implant Prostheses factory where the silicone products were made in the south of France has since been shut down and the implants banned.

The firm is bankrupt. The founder of the company Jean-Claude Mas, a former butcher, is now being sought internationally to answer a Costa Rican drunk driving allegation.

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