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FDA Approves New Silicone Gel-Filled “Gummy Bear” Breast Implant

CHOOSING THE RIGHT BREAST IMPLANT FOR YOU

Choosing a breast implant can be a major step in a woman’s life. A woman’s body is often seen as a reflection of how she views herself. When you are happy with the contour of your body, you feel good about yourself. Many women turn to breast enhancements to increase their breast size and self esteem.

There are two types of breast implants that are improved for sale in the United States; saline-filled and silicone gel-filled. Both of these have a silicone shell, which is smooth or textured and varies in size, shape (contour) and shell thickness. The saline implants are filled with sterile salt water and can be filled with varying amounts of fluid, in order to achieve the desired appearance. Silicone implants are filled with a viscous gel that looks and feels more like normal breast tissue. Until now, the only silicone implants for breast augmentations, in the US, available to women have been round cohesive gel implants. While these implants provide women with excellent aesthetic results, some women feel that the round implants cause an overly augmented look and prefer larger, more natural looking breasts. While breast size and shape are important, it is necessary to communicate your aesthetic goals with your board certified plastic surgeon. The type and size of breast implant are determined by your specific anatomy, skin quality and aesthetic expectations.

NEW FDA-APPROVED SILICONE BREAST IMPLANTS

A new silicone gel-filled breast implant, with a more natural look and feel, has just been FDA-approved. Their anatomic shape is another innovative and ground-breaking feature of these implants. The breast implants are shaped like a teardrop for a more natural looking breast. These implants, used for cosmetic and reconstructive surgery, have been used in Europe for many years. Natrelle 410 is used to increase breast size, known as augmentation, in women at least 22 years old, or to rebuild breast tissue, reconstruction, in women of any age. Natrelle 410 implants are manufactured by Allergen, Inc.

Silicone gel-filled breast implants are medical devices that are implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction.  Placing the implant under the muscle usually provides a longer lasting result with more upper breast fullness. You and your Board-certified plastic surgeon should discuss which implant approach is most appropriate for your cosmetic surgery. Surgical access to the breast includes under the areola, under the breast or through the armpit.

Breast augmentation is the placement of breast implants to increase fullness and projection of the breasts and to improve symmetry. This procedure is used cosmetically to:

  • Enlarge naturally small breasts
  • Restore breast volume following pregnancy, as a result of breast feeding or loss of weight
  • Achieve better symmetry when breasts are moderately disproportionate in size and shape.

Breast reconstruction is used to replace breast tissue that has been removed due to illness or trauma, which has failed to develop properly due to a severe breast abnormality.

The Natrelle 410 implant provides the cosmetic surgeon with yet another tool to give patients the beautiful, natural looking breasts they have always desired. While the results of breast augmentation can be appreciated immediately, satisfaction with your new breasts will continue to grow as you realize the fulfillment of your goal for fuller more beautiful breasts.

Dr. Scott Farber, MD, FACS, has trained with several of the country’s most renowned breast surgeons, has spoken nationally on the topics of cosmetic and reconstructive breast surgery and has coauthored many journal articles on cosmetic breast surgery. Dr. Farber has completed the Allergen Physicians Certification Program and is considered an Expert Breast Surgeon. He takes an individualized approach towards breast augmentation and tailors his technique and implant selection to each patient in order to achieve an optimum result. For a personal consultation at his Boca Raton cosmetic surgery center, please contact Dr. Scott Farber.

FDA SAFETY CONSIDERATIONS

As part of the FDA approval requirements, Allergen is conducting an ongoing clinical core study to evaluate the long term safety and effectiveness of these products with patients who have undergone breast augmentation, breast reconstruction or revision surgeries. Results from these studies to date are showing a reasonable assurance of safety and effectiveness. In addition, Allergen has instituted a separate 10-year post-approval study to address specific issues, including MRI compliance. Benefit, or effectiveness, is assessed by breast size change, regarding patient satisfaction and the quality of life.

Women should be aware that long-term MRI monitoring is required. A woman should continue to perform monthly breasts self exams following breast augmentation and should ask the surgeon to help identify the difference between the implant and her breast tissue. The FDA also recommends MRI screening to detect any side effects three years after receiving the breast implant and every two years thereafter.

The silicone gel in the Natrelle 410 breast implants contains more cross linking, which results in a firmer silicone gel. Cross linking refers to the bonds that link one silicone chain to another. The studies performed by Allergen did not compare the safety and effectiveness of Natrelle 410 breast implants to other previously FDA approved silicone gel breast implants currently on the market.

LIMITED WARRANTIES FOR BREAST IMPLANTS

Confidence Plus Limited Warranties provide lifetime replacement and limited financial reimbursement in the event of shell leakage resulting in breast implant rupture. There are two levels of coverage. The standard warranty automatically applies to every breast implant recipient, subject to certain conditions. The optional plus limited warranty is available for a low enrollment fee and increases the financial benefit in the event of breast implant rupture, subject to certain conditions.