Posts Tagged ‘breast implants’

FDA Implant Update

Thursday, June 23rd, 2011

FDA UPDATE ON SAFETY OF SILICONE BREAST IMPLANTS:

This message forwarded from the American Society of Plastic Surgeons (ASPS):

The Food and Drug Administration (FDA) yesterday issued an updated white paper on the safety of silicone gel-filled breast implants. ASPS agrees with the FDA statement that “silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled,” and it accepts the Agency’s position that women who receive silicone gel-filled breast implants for reconstructive or cosmetic purposes will need to monitor the devices over their lifetime. Both the FDA and ASPS agree that breast implants are not lifetime devices.  ASPS believes that the FDA white paper is informative and will be a fruitful resource for plastic surgeons – as well as for patients considering reconstructive or cosmetic breast augmentation.  ASPS shares the FDA’s view in the white paper that more than 90 percent of patients are satisfied with their outcomes from breast implantation and report an improved quality of life.  ASPS has collaborated – and will continue to collaborate – with the FDA to ensure that science forms the basis for all decision-making on breast implants, as well as all other medical devices. The Society supports post-market breast implant surveillance and ongoing data collection related to the safety and efficacy of breast implants. ASPS will continue to reiterate that patient safety is its No. 1 priority.  The FDA has provided the following links to related documents:  FDA – Breast Implants <http://r20.rs6.net/tn.jsp?llr=49oepqcab&et=1106184345895&s=265&e=0014EX194K8RxV5Ib7kL9bUPyVC8yQnbIGi5yVuc1HCYbRjUJ8gIgLbZOJpS7tyw-JyXMcss8nvG-QTvRJfCmUY53IMzt9q8l36pIb6rTt72Y6CnE-MHULhnNubTlVrmwoZnvI7MglDxD9cS46474skDHOe1VmdwhCWyYfo2eLnAMi6ZVwEEUUJRexCtnc> Update on the Safety of Silicone Gel-Filled Breast Implants (2011) – Executive Summary <http://r20.rs6.net/tn.jsp?llr=49oepqcab&et=1106184345895&s=265&e=0014EX194K8RxVV4o409WicEtEhjssB3e-OI3bByGdOp81jfoSxjVeeWfeLBzMoL2YDqZ3XWfl5iMjszTittG4MifoZ2YlXiweHpNxQPiraPtASxaRpbbdROX9tu2yJhLeOhuYH3fXdMb98622fDhBtRM0PZva8StvO1D-4saWUqXBtZLk9RqhWml2_55W> The FDA also has made available a Consumer Update <http://r20.rs6.net/tn.jsp?llr=49oepqcab&et=1106184345895&s=265&e=0014EX194K8RxXCXTNXpo9Yb9xdIxNtPUbIamUU3Eb94tJA3IPbrQUQNgL5A2TqCcawj_FV6YVexgAHB5m861ycU09fPN2yreR-SvRanfZHbNcqnW01AsKJAi_SkzZ6h-MRqK4VBzUvubSlrhSJEK0xgDq4xEpWMl1jxoh45DCwDbI=> that contains current and background information on breast implants, as well as other links to additional documents and FAQs.  ASPS has posted additional resources for members and consumers on its website at plasticsurgery.org <http://r20.rs6.net/tn.jsp?llr=49oepqcab&et=1106184345895&s=265&e=0014EX194K8RxWDVSTR4TpGUbkWP0sMp3e_GrWrL4JJJS2sWN_U05_VmpKMmuUyO-b8WMFFtOACm1jrTIo0OW–_IuuysfDU-wadXAootfVXhB5Gcj876yDHw==> .  The Society is determined to work collaboratively with the FDA to ensure that plastic surgery patients, consumers and ASPS members are provided the information they need to make informed decisions.

 

FAT INJECTION BREAST ENLARGEMENT

Tuesday, May 3rd, 2011

FAT INJECTION BREAST ENLARGEMENT

Removal of unwanted body fat by liposuction is a well established procedure benefitting thousands of patients. Naturally, the thought then arose, “ Why not remove fat from unwanted areas ( hips and thighs) and replace it into wanted areas ( breast)? “

Over the past 10 years the techniques of fat transplantation have gradually been refined. The limiting factor is that that fat cells are very fragile. Removal often destroys many of the fat cells, and re-implantation yields partial, unpredictable survival. When fat cells die, they can produce small specs of calcification in the tissue.

In most areas of the body lack of survival of fat cells with microcalcification is no big deal. But in the breast, it can cause mammographic changes which look like breast cancer. If that happens, a surgical biopsy is needed.

A recent study from China, published in the April issue of Plastic and Reconstructive Surgery, reports suspicious breast calcification in 16.7 % of patients with fat graft breast augmentation. Other early reports have not shown as many calcifications, but it is too early in the experience to know the true incidence.

There is great enthusiasm for fat grafting for augmentation. It would be the perfect solution – avoiding the hassels of silicone breast implants. But as with any new procedure, it is wise to wait until sufficient experience exists to accurately assess the downside.

 

SALINE OR GEL IMPLANTS?

Thursday, April 28th, 2011

WHAT IS THE DIFFERENCE BETWEEN GEL AND SALINE IMPLANTS?

The first implants developed were gel-filled. They performed well, but some developed surrounding scar, particularly when the shell broke. In response, manufacturers developed inflatable, saline-filled implants.

In general, gel-filled implants are thought to feel slightly more natural to touch. The down-side is that they require a slightly larger incision for placement, and when the shell breaks, they have a historically higher incidence of scar formation ( “getting hard”).

Saline-filled implants avoid the concerns with silicone gel and have traditionally had a lower incidence of scar formation ( “getting hard”). The criticism of saline implants has been a slightly more “wrinkly” feel.