Breast Implants That Are Defective Cause Major Issue for Patients Outside of US

Breast implants manufactured by PIP are causing a major problem outside of the US.  According to TimeLive, a foreign publication, about 2000 Venezuelan women are making threats to sue doctors, private clinics  and distributors for defective breast implants if they do not get them replaced for free. The South American country is one of the world’s busiest markets for plastic surgery so they  were disproportionately affected by the  breast implants sold by French manufacturer Poly Implant Prothese that were filled with industrial-grade silicone. A consumer protection group Anauco says Venezuela – famous for beauty queens, with six Miss Universe titles and six Miss World crowns – imported about 30000 pairs of the breast implants in the past 10 years.

Breast Implants and The Battle to Have Them Removed for Free

Breast implants that need to be removed will require an additional surgery. Anauco plans to meet representatives of clinics, surgeons and the company that imported the breast implants to attempt negotiation for free removal and replacement. “If the doctors lend their hands, the clinics their operating rooms and [the importer] new prosthetics (implants), we will have practically everything we need for these women to get surgery without cost,” Anauco president Roberto Leon said. He said about 2000 women are prepared to file individual claims after they tried to bring a class action suit with no success earlier this year. Poly Implant Prothese went bankrupt but Leon said the lawsuits the Venezuelan women want to join in France are also going after the German certification company TUV Rheinland for compensation. TUV Rheinland says its responsibility was to look into the manufacturing but not the content of the breast implants and that it was misled by Poly Implant Prothese.

Breast Implants in the US are FDA Approved and Different

Breast implants sold in the US must be FDA approved. This tragic situation speaks loudly to the dangers that can happen when patients seek cosmetic surgery outside of the United States. The PIP implants that were found to be faulty were never sold legally in the United States. They were not FDA approved for use in the United States, so therefore did not pass the rigorous standards that exist for medical devices, specifically breast implants today. The implants offered in the US are cohesive gel and not liquid silicone. This means the FDA approved gel implants stay reasonably intact and “together ” within the implant shell. Liquid silicone, as a liquid, can leak outside of the implant if there is a rupture.  Dr. Seify explains to patients who are considering breastaugmentation that the breast implants he uses within his practice are FDA approved and have passed the rigorous testing required. Patients are given information concerning the  breast implants directly from the manufacturer as well as access to the FDA website which clearly explains the FDA approval of silicone breast implants and their recommendations. The major manufacturers of breast implants both offer extended 10 year warranties as well as a lifetime replacement warranty on the implants. Breast augmentation even when combined with breast lift remains one of the most sought after procedures with relatively low complication rates involving the breast implants. Dr. Seify is committed to educating patients concerning their breast implants and the long-term care and maintenance of them as medical devices.

 

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