Establishment Labs Holdings Inc., a global medical technology company, has presented an update on the Motiva US IDE Study, sharing four-year patient follow-up data for primary breast augmentation subjects.
Dr. Caroline Glicksman, the Medical Director and Investigator of the Study, presented the results at The Aesthetic Meeting 2024 in Vancouver, BC Canada. The study included 451 patients enrolled in the trial, with a compliance rate of 88.9% at the four-year follow-up visit.
The findings revealed low rates of complications in the primary augmentation cohort. The four-year risk rates of first occurrence of complications were as follows: 0.5% for capsular contracture (Baker Grade III/IV), 10.6% for suspected or confirmed rupture, 0.9% for breast pain and infection, 1.8% for implant removal, and 26.8% for any reoperation. Overall, the rate of any complication was 39.6%.
Dr. Glicksman emphasized the consistency of these clinical results over the four-year period, noting that there has been no increase in capsular contracture or rupture. She highlighted the high patient follow-up rate and the low rates of complications, stating that the Motiva Implant PMA is currently under review by the FDA.
Establishment Labs is dedicated to improving women’s health and wellness through its medical technology solutions. The company offers a portfolio of Femtech solutions for breast health, aesthetics, and reconstruction. Motiva silicone gel-filled implants, though not approved for commercial distribution in the United States, have set a new standard for safety and patient satisfaction in over 85 countries.
The Motiva Core pivotal study, conducted under an FDA-approved Investigational Device Exemption, aims to gather comprehensive data on the investigational medical device. With over three million devices delivered since 2010, Establishment Labs continues to advance breast health treatment options. Their Motiva Flora tissue expander, which improves outcomes in breast reconstruction, is the only regulatory-approved expander worldwide with an integrated port using radio-frequency technology that is MRI conditional.
While the Motiva implants are still awaiting regulatory approval in the United States, the promising four-year data from the Motiva US IDE Study suggests that these implants could soon become the new standard in breast augmentation and reconstruction procedures worldwide. Women can anticipate safer and more satisfactory outcomes with this innovative medical technology.
The findings from the Motiva US IDE Study presented by Dr. Caroline Glicksman at The Aesthetic Meeting 2024 show promising results for the Motiva silicone gel-filled breast implants. The study included 451 patients with a high compliance rate of 88.9% at the four-year follow-up visit.
The study revealed low rates of complications in the primary augmentation cohort. The rates for the first occurrence of complications at four years were as follows: 0.5% for capsular contracture (Baker Grade III/IV), 10.6% for suspected or confirmed rupture, 0.9% for breast pain and infection, 1.8% for implant removal, and 26.8% for any reoperation. The overall rate of any complication was 39.6%. Importantly, there was no increase in capsular contracture or rupture over the four-year period, which highlights the consistency of these clinical results.
One advantage of the Motiva implants is their high patient follow-up rate, which indicates thorough monitoring and evaluation of the outcomes. Additionally, the low rates of complications suggest that the Motiva implants offer a safe option for breast augmentation and reconstruction procedures.
However, it is important to note that the Motiva implants are still awaiting regulatory approval in the United States. Although they have set a new standard for safety and patient satisfaction in over 85 countries, their commercial distribution in the US is not yet approved.
In terms of market trends, the demand for breast augmentation and reconstruction procedures continues to grow globally. According to a report by Grand View Research, the global breast implants market is expected to reach $2.0 billion by 2027, driven by factors such as increasing aesthetic consciousness and advancements in implant technology. If the Motiva implants receive regulatory approval in the US, they could potentially capture a significant portion of this market.
One key challenge associated with breast implants is the risk of complications, such as capsular contracture and rupture. The low rates of these complications observed in the Motiva US IDE Study are encouraging, but it is important for healthcare providers and patients to be aware of the risks and make informed decisions.
In conclusion, the four-year data from the Motiva US IDE Study suggest that the Motiva silicone gel-filled breast implants could soon become the new standard in breast augmentation and reconstruction procedures worldwide. The low rates of complications and consistent clinical results make them an attractive option for women seeking safer and more satisfactory outcomes. However, it is crucial to wait for regulatory approval in the United States before these implants become available for commercial distribution.
For more information on breast implants and related topics, you can visit the website of Establishment Labs Holdings Inc., the company behind Motiva implants, at establishmentlabs.com. Additionally, you may find the website of The Aesthetic Society, the organization behind The Aesthetic Meeting, informative for updates on the latest advancements in aesthetic medicine at surgery.org.