In 1988, twenty-six years after the 1962 introduction of breast implants filled with silicone gel, the U.S. Food and Drug Administration (FDA) investigated breast implant failures and the subsequent complications, and re-classified breast implant devices as Class III medical devices, and required from manufacturers the documentary data substantiating the safety and efficacy of their breast implant devices. In 1992, the FDA placed silicone-gel breast implants in moratorium in the U.S., because there was “inadequate information to demonstrate that breast implants were safe and effective”. Nonetheless, medical access to silicone-gel breast implant devices continued for clinical studies of post-mastectomy breast reconstruction, the correction of congenital deformities, and the replacement of ruptured silicone-gel implants. The FDA required from the manufacturers the clinical trial data, and permitted their providing breast implants to the breast augmentation patients for the statistical studies required by the U.S. Food and Drug Administration. In mid–1992, the FDA approved an adjunct study protocol for silicone-gel filled implants for breast reconstruction patients, and for revision-surgery patients. Also in 1992, the Dow Corning Corporation, a silicone products and breast implant manufacturer, announced the discontinuation of five implant-grade silicones, but would continue producing 45 other, medical-grade, silicone materials—three years later, in 1995, the Dow Corning Corporation went bankrupt when it faced large class action lawsuits claiming a variety of illnesses.
Case 94: This patient was seeing the early signs of facial aging including loss of skin tone and elasticity, early jowling, and heaviness under the chin. A lower facelift along with fat transfer to the under eye and cheek area substantially improved the contour and even apparent texture of her skin, making her look noticeably younger. In addition, the overall effect was completed with a rhinoplasty focused on reducing the width, rounding, and thickness of her tip and nostrils which is a challenge in the setting of thick skin.
Case 47: This patient’s primary surgery left her with valve collapse, nostril notching, persistent tip rounding and hanging columella. Secondary surgery involved correction of these issues with repositioning and reconstruction of the tip cartilages to improve tip contour. Although she is still a little swollen in the after photos, she is already happy with her new nose.
During your initial consultation, you will have the opportunity to discuss what you want to achieve. Your surgeon will evaluate you as a candidate for fat grafting and clarify what fat grafting can do for you. Once the surgeon understands your goals, he or she may suggest additional or related procedures. It is important to be completely honest during the consultation. Bring several photos of yourself at an earlier age; they may serve as a good point of reference for discussing your goals. It’s a good idea to be fully prepared to answer these questions:
Implants come in various sizes, and your surgeon will guide you on choosing the right size to help you achieve the look you desire. In addition, your surgeon will help you decide whether you want a more natural, teardrop shape or a more rounded look. Implants also come with either smooth our textured shell surfaces, and your surgeon will help you decide which is best for you.
For detailed indications, contraindications, warnings, and precautions associated with the use of all MENTOR® Implantable Devices, which include MENTOR® Saline-filled Implants, MemoryGel® Implants, MemoryShape® Implants, ARTOURA™ Expanders, and CONTOUR PROFILE® Expanders, please refer to the Instructions for Use (IFU) provided with each product or visit www.mentorwwllc.com.
Each year, hundreds of thousands of women undergo breast implant surgery, a plastic surgery procedure designed to improve the appearance of the breasts. Also called breast augmentation surgery, most women undergo the procedure to enlarge breasts that are naturally small, though some have it to correct disproportionate breasts or repair breast deformities.
Dr. Mess receive patients from many for Washington DC and nearby cities and performs the fat transfer in her office in Columbia, Md, at Northwest Hospital near Baltimore, and at Howard County General Hospital. There are different techniques for fat transfer depending on the area being treated; small volume to face and hands vs. medium volume to enhance breast reconstruction vs. large volume to enhance buttocks and augment breast without implants. Common donor sites are the patient’s abdomen, thighs, or love handles. The fat is suctioned by hand for small volume and by liposuction machine for large volume. The fat is gently separated to concentrate the viable fat from fluid and nonessential matter. The concentrated fat is re-injected into the desired area with small cannulas designed to maximize the survival of the transferred fat. Dr. Sarah Mess has spent years refining her fat transfer technique to offer her patients outstanding fat transfer outcomes.
In 1998, the U.S. FDA approved adjunct study protocols for silicone-gel filled implants only for breast reconstruction patients and for revision-surgery patients; and also approved the Dow Corning Corporation's Investigational Device Exemption (IDE) study for silicone-gel breast implants for a limited number of breast augmentation-, reconstruction-, and revision-surgery patients.
Manufacturer’s warranty programs can mitigate some of the costs of treating complications. But, the warranty payment is only available if a rupture is detected. Some surgeons fail to inform their patients of the need for periodic MRIs, or downplay the FDA recommendation in order to make a sale. “Many women don’t know about the maintenance costs and potential expenses of silicone gel implants,” reports Dr. Ellen Mahony, board-certified plastic surgeon in Westport, CT. “Because rupture with a silicone gel implant is ‘silent,’ it can go undetected for an extended period, often not becoming obvious until the process of capsular contraction has begun.” Capsular contraction leads to a more complex surgery. That means added surgical costs which your warranty may not cover.