Comprehensive Analysis of Long-Term Safety Studies Reaffirms Smooth and Textured Breast Implants as Safe & Important Option for Patients Undergoing Aesthetic or Reconstructive Breast Surgery
First-of-its-kind peer-review analysis of all reliable data including low-risk of BIA-ALCL
Santa Barbara, California (September 28, 2017) — The broadest long-term review of safety results to date was published online today in the Aesthetic Surgery Journal. The article is a comprehensive, first-of-its-kind review of current published data about all breast implants, and establishes their role as safe and important options for patients undergoing aesthetic or reconstructive breast surgery.
Clinical data from all FDA-approved 10-year studies, including comparisons of smooth and textured and shaped and round breast implants, showed that the devices performed safely over the long-term. The authors discuss the long-term outcomes associated with breast implants including the leading cause of morbidity, capsular contracture, and the evidence-based recommendations for reducing this risk. Additionally, the very rare, but important topic of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is reviewed including theories on pathogenesis.
"This analysis reaffirms the importance of ensuring women have options available, along with the information they need to make educated choices about breast implants," said Dr. Bradley Calobrace, one of the authors of the analysis. "Surgeons now have a wealth of data to evaluate when assessing and discussing the benefits and risks of smooth and textured implants with their patients."
The authors also noted that concern for the rare occurrence of BIA-ALCL has recently overshadowed the ability to have a fair and comprehensive discussion about textured implants, which have more than 30 years of demonstrated safety.
"Textured implants are an important option for patients as they undeniably provide a reduction in capsular contracture over time," added Dr. W. Grant Stevens, senior author of the analysis. "The benefits of textured implants far exceed the extremely rare occurrence of BIA-ALCL. To give up those benefits to women in an attempt to avoid the rarity of this condition is not sound judgement."
The evolution of breast implant technology and refinements over time has led to continued improvements in patient outcomes. Sientra is committed to remaining at the forefront of this research through partnerships and collaborations with board-certified plastic surgeons, medical societies, regulatory bodies and advocacy groups.
"We are pleased this comprehensive first-of-its-kind review supports the safety and importance of smooth and textured implants," said Rosalyn d'Incelli, Sientra Vice President of Clinical and Medical Affairs. "Our long-term clinical studies of Sientra smooth round, textured round, and textured shaped implants demonstrate relatively low rates of rupture, reoperation, capsular contracture and high patient satisfaction. Sientra stands behind the safety, effectiveness and quality of all our products and will continue to support patient and surgeon awareness and education around implants."
Headquartered in Santa Barbara, California, Sientra is a medical aesthetics company committed to making a difference in patients' lives by enhancing their body image, growing their self-esteem and restoring their confidence. The Company was founded to provide greater choice to board-certified plastic surgeons and patients in need of medical aesthetics products. The Company has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The Company sells its breast implants and breast tissue expanders exclusively to board-certified and board-admissible plastic surgeons and tailors its customer service offerings to their specific needs. The Company also offers a range of other aesthetic and specialty products including BIOCORNEUM®, the professional choice in scar management, and miraDry®, the only FDA cleared device to reduce underarm sweat, odor and permanently reduce hair of all colors.