Testimonials

Are Silicone Breast Implants FDA Approved?

Silicone Breast ImplantsSilicone breast implants were approved by the FDA on November 17th, 2006. Ever since then, the popularity of these implants has grown with each passing year, and breast augmentation has become one of the sought after cosmetic surgeries in the United States. The safety and performance of these implants is continually monitored through long-term post-approval studies by the FDA.

Patients typically report very high success rates with these implants. Dr. Nicholas Vendemia in Manhattan, NYC, who is an experienced cosmetic surgeon for procedures such as breast augmentation, breast lift and breast reduction, recommends the latest qualities in silicone implants to his patients. The proven effectiveness of these implants can help a plastic surgeon meet the patient’s aesthetic goals from breast augmentation surgery.

Studies on Safety and Performance

Prior to the FDA approval for silicone breast implants, some patients had concerns regarding the safety and long-term performance of silicone implants. One of the key worries was that in the event of implant malfunction, damage or breakage, the silicone gel might leak and travel to other parts of the body, causing potential harm. However, these concerns were adequately addressed during detailed studies about the safety and performance of silicone implants by the manufacturers.

The FDA conducted a thorough review of the clinical and pre-clinical studies of each of the manufacturers. The studies were also reviewed by independent scientific groups as well as external expert advisory panels deliberated over the results of these studies. The FDA went one step further and conducted inspections of each of the manufacturer’s facilities to determine their compliance with the appropriate quality standards. The majority of women who participated in these scientific studies reported being satisfied with the breast implants.

As an experienced breast augmentation surgeon, Dr. Vendemia assessed and evaluated the high safety and performance standards of silicone implants. Considering their excellent aesthetic benefits and safety standards, he likes to recommend highly cohesive silicone implants to his patients in New York City and surrounding areas.

A Soft and Natural Feel

One of the strong points of silicone implants is that they are able to mimic the soft and natural touch and feel of breast tissue very closely. To make them safe against gel leakage, the manufacturers surround the silicone gel core with three layer of outer shell. While this makes the implants slightly firmer, but most patients prefer a firmer feel because it still remains soft and natural to touch.

Highly Cohesive Silicone Implants

With the FDA giving its approval to highly cohesive silicone gel implants, patients now have the opportunity to receive the most advanced qualities in breast implants. The touch, feel, and overall experience with these implants leave the previous technologies significantly behind. Leakages with these implants are a thing of the past, and the patient can enjoy a wholesome breast enhancement experience in terms of safety as well as performance.

Tests with highly cohesive implants have shown that even when the implant shell is cut in half or it is squeezed, turned upside down or shaken, the silicone gel does not move away from its core. The gel remains solid, but the implant remains soft and supple from the outside.

For more information on cosmetic surgery procedures and treatments Plastic Surgeon, Dr. Nicholas Vendemia (Dr. V) performs in New York City / Manhattan visit: 

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