Category Archives: Cosmetic Surgery

5 things to know about breast implants

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A Consumer Update for the FDA

breast implantShould I get breast implants? Are there alternatives? Will they need to be replaced?

And if you decide to get implants, there are even more questions. Saline or silicone?  What style? How much monitoring is needed?

Researching breast implants can be overwhelming and confusing. The Food and Drug Administration (FDA) has online tools available to help women sort through the information and provides questions to consider before making the decision.

Know the Basics

FDA has approved implants for increasing breast size in women, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. Implants are also approved to correct or improve the result of a previous surgery.

A number of studies have reported that a majority of breast augmentation and reconstruction patients are satisfied with the results of their surgery.

FDA has approved two types of breast implants for sale in the U.S.: saline (salt water solution)-filled and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness and shape.

Know the Risks

Silicone implants sold in the U.S. are made with medical-grade silicone.  These implants undergo extensive testing to establish reasonable assurance of safety and effectiveness. Nonetheless, there are risks associated with all breast implants, including:

  • additional surgeries
  • capsular contracture—scar tissue that squeezes the implant
  • breast pain
  • rupture (tears or holes in the shell) with deflation of saline-filled implants
  • silent (without symptoms) rupture of silicone gel-filled implants

FDA experts suggest five things women should know about breast implants.

1. Breast implants are not lifetime devices.

The longer a woman has them, the greater the chances that she will develop complications, some of which will require more surgery.  The patient can also request additional surgeries to modify the aesthetic outcome, such as size or shape.

“The life of these devices varies according to the individual,” says Gretchen Burns, a nurse consultant at FDA’s Center for Devices and Radiological Health (CDRH).  “All women with implants will face additional surgeries—no one can tell them when.” While a few women have kept their original implants for 20-30 years, “that is not the common experience.”

2. Research products.

Review the patient labeling. FDA advises that women look at the Summary of Safety and Effectiveness Data (SSED) for each implant to learn about their characteristics and the fillers used. SSEDs have been produced for all approved saline and silicone gel-filled breast implants. These summaries provide information on the indications for use, risks, warnings, precautions, and studies associated with FDA approval of the device. Look at the frequency of serious complications found in the SSED. The most serious are “those that lead to further surgeries, such as ruptures or capsular contracture,” says Tajanay Ki, a biomedical engineer in CDRH.

FDA advises health care providers to give women the full labeling—all of the patient information from the manufacturer—for an implant. Ask your surgeon for the most recent version of the labeling. You should have at least 1-2 weeks to review the information before making a decision, but with some reconstruction or revision surgery cases, it may be advisable to perform surgery sooner.

3. Communicate with the surgeon.

Surgeons must evaluate the shape, size, surface texture and placement of the implant and the incision site for each woman. Ask the surgeon questions about his or her professional experience, the surgical procedure, and the ways the implant might affect an individual’s life.

Also, tell the surgeon about previous surgeries and your body’s response—for example, whether surgeries resulted in excessive scar tissue—and discuss your expectations. This helps the surgeon make operative decisions that achieve the desired appearance (i.e., incision location and size, implant size and placement).  Many women undergo reoperation to change implant size.  To achieve optimal results after the first procedure, careful planning and reasonable expectations are necessary.

4. Learn about long-term risks. 

Some women with breast implants have experienced connective tissue diseases, lactation difficulties or reproductive problems. However, current evidence does not support an association between breast implants and these conditions. FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. Women who have breast implants may have a very small but increased risk of developing ALCL in the fluid or scar tissue surrounding the implant. Like other lymphomas, ALCL is a cancer of the immune system and not of breast tissue.

5. Monitoring is crucial. 

FDA recommends that women with breast implants:

  • promptly report any unusual signs or symptoms to their health care providers, and
  • report any serious side effects to MedWatch, FDA’s safety information and adverse event reporting program.

Furthermore, women with silicone implants should get MRI screenings to detect silent ruptures three years after their surgery and every two years after that.  Insurance may not cover these screenings.

Burns recommends that women with breast implants continue to perform self-examinations and get mammograms to look for early signs of cancer. “Just because you have implants doesn’t mean you can ignore other breast health recommendations,” she says.

FDA’s Online Resources

FDA has a breast implants web page (www.fda.gov/breastimplants) with resources that include:

  • Links to patient information and data for each product.
  • Information about risks and complications
  • Questions to ask health care professionals regarding breast implant surgery
  • Contact information for manufacturers of FDA-approved breast implants and related professional organizations

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

February 20, 2013

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Teaching the very young to swim could save thousands of lives a year, UW researcher says

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infant-swimmingTeaching very young children to swim could save thousands of lives a year around the world, writes UW’s Dr. Frederick Rivara in this month’s issue of the Archives of Pediatric & Adolescent Medicine.

Dr. Rivara, head of the Division of Pediatrics at the University of Washington School of Medicine, was commenting on an study in the journal finding that formal swimming instruction of children age 1 to 4 years old reduced their risk of drowning by 88%.

Currently, about 200,000 children and adolescents around the world drown each year. In the U.S., drowning is the second most common cause of injury death for children age 0 to 14 years—and drowning is the leading cause of overall death in children younger than 15 in countries such as China and Bangladesh.

The study also found that swimming instructions appeared to reduce the risk of drowning in children after 5 to 19 years, but because of the small number of cases in the study the results were not statistically significant.

The study looked at drowning cases in several regions of the U.S. and compared them with randomly selected living children of similar age to serve as “controls”.

 In the 1- to 4-year-old group, the researchers interviewed the families of 61 drowning victims. Of the children who drowned only 2 (3 percent) had ever taken formal swimming lessons. Of the 134 “control” children, on the other hand, 35 (26 percent) had had formal swimming instructions. 

The findings suggest that formal swimming lessons can reduce a young child’s risk of drowning by 88 percent. The lead author of the study was Dr. Ruth Brenner of the National Institute of Child Health and Human Development.

In his commentary on the study, Dr. Rivara writes that teaching children to swim can be done “pretty much anywhere in the world without need for Olympic-sized swimming pools.” 

A program in Bangladesh, for example, that uses bamboo barriers to create safe swimming areas in lakes and rivers has been able to teach thousands of children to swim at a cost less than $5 per child, Rivara points out.

Swimming lessons should not take the place of such strategies as pool fencing and adult supervision, Rivara writes, but “formal swimming lessons offer an opportunity to make a real difference in communities around the globe….”

To learn more:

 

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Morning Report: health stories in the news

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newspaperHealth-care reform should help individuals live healthier lives

U.S. health-care reform should support social-marketing campaigns to combat obesity and promote preventive care, writes Greg Vigdor, president and CEO of the Washington Health Foundation, in an op-ed article in the Seattle Times.

Vigdor cites a recent report by the United Health Foundation finding that while Washington has moved from the 14th to the 10th healthiest state, it still faces many health challenges including soaring obesity rates among both adults and children.

The commitment to these campaigns should be equal in “scale and intensity” to the smoking-cessation campaigns that has led to a significant drop in smoking rates in Washington state, Vigdor says.

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Better option for breast reconstruction?

The New York Times reports today that many women getting breast implants after mastectomy are not being informed of a more complex reconstructive procedure using their own fat tissue that can have a better long-term outcome.

Surgeons often prefer performing the implant procedures because they are easier to do and pay better than the more complex alternatives, writes Times reporter Natasha Singer.

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Do drug and alcohol rehab programs work?

Very few drug and alcohol rehabilitations programs have evidence that they are effective, the field has no standard guidelines, and each program has its own philosophy, writes New York Times reporter Benedict Carey in today’s paper.

“No one knows which approach is best for which patients,” Carey writes, “because these programs rarely if ever track clients closely after they graduate.”

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