After a decade of waiting, the US Food and Drug Administration has approved implants incentives for breast growth and review surgery-the first new US implant approval in the US since 2013. To understand what they are now using, In the world of breast surgery.
Suggested Experts
- Dr. Caroline GlickSman is a plastic surgeon certified to the board in Wall Township, NJ
- Dr. Steven Teitelbaum is a plastic surgeon certified on the boat in Santa Monica, Ca
- Dr. Bradley Calobrace is a plastic surgeon certified to the Council in Louisville, KY
- Dr. Tracey N. Cook is a plastic surgeon eligible on board in Louisville, KY
What makes motivation unique?
Implants motivate the attention to their advanced features, which surgeons say they face long -term challenges in breast growth. A key innovation is the Smoothsilk surface, which surgeons describe as a decrease in inflammation and minimizing the risk of capsic contraction, a common complication. “Based on the three -year data, there are very low caps of capsuits,” said Wall Township, NJ Plastic Surgeon Caroline Glicksman, MD, who served as medical director of the US study IDE. “Capsular Contracture has been one of the most common reasons for implant reviews and with Motiva. We see dramatically reduced rates.”
“In addition to the US, implants motivation have been used in more than 85 countries since its first availability in 2010,” says Louisville, Ky Plastic Surgery Tracey N. Cook, MD. “American food and drug approval comes after strict clinical trials, demonstrating the safety and effectiveness of the Motiva breast implant, giving surgeons and patients with additional options to increase the breast.”
Results of clinical trials
Clinical trials for the approval of Motiva FDA included more than 1,000 patients in primary growth and review groups. In three years, the rate of contracts for patients with primary increase was below 1 %, the rupture rates were 0.6 %and patient satisfaction exceeded 95 %.
The Motiva study stands out as a “modern clinical trial”, says Dr. Glicksman because it has overcome the implant evaluation. It collects detailed data on factors such as incision size, implant placement and surgical techniques, ensuring a comprehensive approach. “We didn’t just study the device. We studied how modern surgical practices affect the results,” he explains. “This makes this test so unique.”
Above or behind the muscle.?
Most surgeons in the study placed implants behind the muscle, with over 95 percent choosing a double -level approach to minimize ripple and capsule contraction. While underwater placement (above the muscle.) Gains interest in benefits such as easier recovery, Dr. Glicksman noted: “We still do not have data to fully support these allegations. The company should continue to collect data as these techniques are evolving.”
The ‘softness’ factor
One of the standouts characterizes the surgeons who report consistently is the softness of implants. “The feeling of implant is so similar to the normal breast tissue that is almost undetectable,” notes Dr. Teitelbaum. “Patients who hesitated implants who feel harsh or abnormal are particularly enthusiastic about this choice.”
Dr. Glicksman added that her patients often comment on how soft the implants feel. “Patients often tell me that these are the softest implants they have ever felt. Many of them compare the sense of memory foam and love how natural and comfortable they are. They are one of the main reasons that choose the motivation,” he shared.
The implants come in two styles: the Smoothsilk Round implant, which maintains a rounded shape for the full pole fullness and Ergonomix, which adapts to the body placement for a more tear appearance. “These two styles allow the surgeons to adapt the option of implant based on the patient’s goals and anatomy,” said Dr. Calobrace.
Who should consider motivation implants?
The motivation implants are currently approved by the FDA for cases of primary growth and revision. Although they have not yet been approved for reconstruction, surgeons agree that they are particularly suitable for patients with increased first employment or those who replace the older implants.
“These implants are ideal for patients who have adequate soft tissue and want a natural look and feel,” Dr. Glicksman said. “It’s a wonderful implant of review because it’s so soft and comfortable. Many of my patients are surprised by how much better they feel compared to their previous implants,” he shared.
What is in front of
“This is an exciting moment for both surgeons and patients,” noted Dr. Glicksman. “It’s been over a decade since we had a new choice like this and shows that innovation is possible when strict data and cooperation meet.”
