Is anyone worried about the warranty on their Sientra implants with the manufacturing & sales in the USA stopped?
Recently got implants from Dr. Oppenheimer & worried about possible problems.
Doctor Answers 5
Many patients are concerned, as you are, about their health and the long term implications of their Sientra implants. It is important to know that regulatory agencies around the world are in agreement that there are no patient safety issues related to the halt placed on the production of implants by Silimed which makes breast implants for Sientra. To be cautious, Sientra has temporarily and voluntarily halted sales of their implants while an investigation is completed. It is too early to worry about your warranty, and there is no need to be concerned about your health. Your plastic surgeon, like other board certified plastic surgeons, will be among the first to hear updates from Sientra, our plastic surgery society, and the FDA.
Many patients are concerned, as you are, about their health and the long term implications of their Sientra implants. It is important to know that regulatory agencies around the world are in agreement that there are no patient safety issues related to the halt placed on the production of implants by Silimed which makes breast implants for Sientra. To be cautious, Sientra has temporarily and voluntarily halted sales of their implants while an investigation is completed. It is too early to worry about your warranty, and there is no need to be concerned about your health. Your plastic surgeon, like other board certified plastic surgeons, will be among the first to hear updates from Sientra, our plastic surgery society, and the FDA.
It is important to note that Sientra has discontinued sales voluntarily, with no indication that any patient safety issues exist at this time. Plastic surgeons are receiving updates from Sientra and the American Society of Plastic Surgeons as more information is available. At the present time, we have no indication of cause for concern about warranties. However since the details are being investigated this could change at any time. I would advise keeping in touch with your plastic surgeon for updates. Best of luck to you!
Web reference: http://www.clevensfaceandbody.com/breast-procedures/breast-augmentation
It is important to note that Sientra has discontinued sales voluntarily, with no indication that any patient safety issues exist at this time. Plastic surgeons are receiving updates from Sientra and the American Society of Plastic Surgeons as more information is available. At the present time, we have no indication of cause for concern about warranties. However since the details are being investigated this could change at any time. I would advise keeping in touch with your plastic surgeon for updates. Best of luck to you!
Learn more: http://www.clevensfaceandbody.com/breast-procedures/breast-augmentation
In today's breast implant environment any removal of a product from the market for manufacturing irregularities are always of concern. The European Drug Commission stopped the sale of Sientra (Silimed) implants in Europe out of an over abundance of caution. It seems that some type of particulate material was found on the implants either a fiber or silicone. The removal from the US market was voluntary. I would imagine that after the manufacturing process has been reviewed and corrected the implants will be back on the market. At point the FDA has not issued a US warning. Slimed implants are marketed worldwide and are manufactured in Brazil. Only thing one can do at this point is to understand that there are not health concerns with the use of these implants. There has been no indication at this point from Sientra when the implants will be released for use in the US. I believe the company is required to have money in escrow to cover costs of potential warranty issues.
In today's breast implant environment any removal of a product from the market for manufacturing irregularities are always of concern. The European Drug Commission stopped the sale of Sientra (Silimed) implants in Europe out of an over abundance of caution. It seems that some type of particulate material was found on the implants either a fiber or silicone. The removal from the US market was voluntary. I would imagine that after the manufacturing process has been reviewed and corrected the implants will be back on the market. At point the FDA has not issued a US warning. Slimed implants are marketed worldwide and are manufactured in Brazil. Only thing one can do at this point is to understand that there are not health concerns with the use of these implants. There has been no indication at this point from Sientra when the implants will be released for use in the US. I believe the company is required to have money in escrow to cover costs of potential warranty issues.
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While my friend and colleague Dr Jeff Hartog points out important issues, I also would be concerned about the loss of warranty from Sientra if the company goes belly up. My guess is the other more established implant companies (Allergen & Mentor) would offer some limited type of warranty as a good will gesture. Makes good business sense. Lets all await and see what transpires. BTW I used a few Sientra implants and decided to stop over 2 years ago, had a feeling to say the least..
While my friend and colleague Dr Jeff Hartog points out important issues, I also would be concerned about the loss of warranty from Sientra if the company goes belly up. My guess is the other more established implant companies (Allergen & Mentor) would offer some limited type of warranty as a good will gesture. Makes good business sense. Lets all await and see what transpires. BTW I used a few Sientra implants and decided to stop over 2 years ago, had a feeling to say the least..
It is very important to appreciate that the halt in Sientra sales is almost certainly likely to be temporary, and so is very likely to be temporary. Sientra voluntarily stopped sales temporarily out of an abundance of caution while a single anonymous complaint made in Europe about manufacturing procedures is investigated. There has never been a single patient complaint or instance of patient harm with Sientra implants related to the manufacturing process. Nevertheless it is required by the FDA that all complaints, even if anonymous be investigated. This requires that all processes and procedures at the manufacturing plant are reviewed and checked in detail. We are hopeful that the halt will only be temporary.
It is very important to appreciate that the halt in Sientra sales is almost certainly likely to be temporary, and so is very likely to be temporary. Sientra voluntarily stopped sales temporarily out of an abundance of caution while a single anonymous complaint made in Europe about manufacturing procedures is investigated. There has never been a single patient complaint or instance of patient harm with Sientra implants related to the manufacturing process. Nevertheless it is required by the FDA that all complaints, even if anonymous be investigated. This requires that all processes and procedures at the manufacturing plant are reviewed and checked in detail. We are hopeful that the halt will only be temporary.
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.
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