• Breast implants are the medical devices which are implanted under the breast tissue or the chest muscle to increase the breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction).
• The FDA has approved implants for increasing breast size in women (augmentation), for reconstruction after breast cancer surgery, and to correct the developmental defects. Implants are also recommended to repair or improve the result of the previous operation.
• The FDA has approved two types of breast implants for sale in the United States: saline (salt water solution)-filled and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness, and shape.
Market Drivers
• Increase in beauty consciousness and breast cancer has driven the global breast implant market.
• In 2015, nearly 280,000 women and teenagers underwent surgery to have their breasts enlarged with silicone or saline implants, and about 106,000 breast cancer patients had reconstruction after mastectomy, often with implants.
• Breast augmentation is the number one cosmetic surgery in the U.S., with over 290,000 procedures completed in 2016.
Market Restraints
• The breast implant has various side-effects, such as implant rupture, wrinkling, bleeding, asymmetry, anesthesia reaction, scarring, pain, and infection.
• These complications occur in at least 1% of breast implant patients
• Up to 20% of women who decide to have breast implant surgery have them removed within 8 to 10 years.
• Due to such side effects, the global breast implant market is expected to be hampered over the forecast period.
• The silicone breast implant segment dominates the global breast implant market. Most of the breast augment procedures performed worldwide comprised of silicone breast implants.
• Increasing cases of cancer and mastectomy will increase the demand for silicone breast implants in the future, since they have less chance of visible wrinkling or rippling, making them an improved choice for post-mastectomy breast reconstruction.
• The launch of highly cohesive silicone gel breast implants has reduced the complication of rupturing, a significant complexity associated with the breast implant procedure.
• The market segments hold a large market share in the forecast period and there is a growth market size of the products.
By geography
• North America dominates the global breast implant market in 2017. Increasing breast cancer cases in the U.S. is expected to boost the North America breast implant market over the forecast period –
• For instance, in 2018, an estimated 266,120 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S., along with 63,960 new cases of non-invasive breast cancer.
• Breast augmentation and breast reconstruction are the most popular surgical procedures in North America. The U.S. holds the dominant share in the North America region.
• The FDA approved saline-filled breast implants for women aged 18 years. Only three companies have FDA approval to market saline implants in the US. Allergan and Mentor received FDA approval in 2000, and Ideal Implant received FDA approval in November 2014.
Competitive Trends
• The increase in approvals by the FDA on the manufacturing of breast implant products is driving the global breast implant market.
• In April 2018, Ideal Implant Incorporated announced that they had received FDA approval to manufacture their Structured Breast Implant at Vesta, a Lubrizol LifeSciences company of silicone products and other medical devices.
• In April 2018, Sientra, Inc. have announced that Food and Drug Administration (FDA) has approved the Company’s PMA supplement allowing commercialization of its OPUS-branded breast implant products manufactured by Vesta, a Lubrizol LifeSciences company, at Vesta’s Wisconsin-based manufacturing facility.
• In April 2017, Mentor Worldwide LLC, a global leader in breast aesthetics, has announced that it has received approval from the U.S. Food & Drug Administration (FDA) to market MemoryGel® Xtra silicone gel-filled breast implants in the U.S.
• In January 2017, Allergan plc has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA® SoftTouch breast implants, offering women undergoing breast reconstruction, augmentation or revision surgery a new medium firmness gel, or cohesive, implant option.
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