Breast implants are medical devices that are used to augment the size of the breasts, either for cosmetic applications or reconstruction purpose. Round breast implants are the most commonly used breast implants. Round breast implants have a tendency to appear fuller and there is less concern about rotating them in place as they are same shape all over.

Statistics:

The global breast implants market is estimated to account for US$ 1,671.3 Mn in terms of value by the end of 2027.

Global Breast Implants Market: Drivers

Increasing prevalence of breast cancer is expected to propel growth of the global breast implants market over the forecast period. For instance, according to Breastcancer.org, in 2019, an estimated 268,600 new cases of invasive breast cancer were expected to be diagnosed in women in the U.S. along with 62,930 new cases of non-invasive (in situ) breast cancer.

Moreover, increasing adoption of highly cohesive silicone breast implants is also expected to aid in growth of the market. Silicone breast implants have high strength silicone gel that is textured with silicone shell. Such implants are thicker and contain more cohesive silicone gel, which eliminates the probability of filler leakage into the body.

Statistics:

North America held dominant position in the global breast implants market in 2019, accounting for 35.9% share in terms of value, followed by Latin America and Europe, respectively.

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Global Breast Implants Market: Restraints

High cost of breast augmentation is expected to hamper growth of the market. For instance, in India, the total cost of breast augmentation (including cost of implants and cost of surgery) is around US$ 2,800.

Moreover, high risk of developing serious complications is also expected to limit the market growth. Breast implants are not lifetime devices and undergoing breast implant surgery may involves the risk of complications ultimately leading to breast implants removal at some point. Commonly observed complications include, tightening of the area around the implant (capsular contracture), additional surgeries, and implant removal.

Market Trends/Key Takeaways

The market in Asia Pacific is driven by increasing prevalence of breast cancer. For instance, according to the Union Health Ministry, Government of India, 2018 data, the prevalence of breast cancer is 25.8 per 100,000 women and the mortality rate for the disease is 12.7 per 100,000 women. Moreover, around 17, 97,900 women in India may suffer from breast cancer by 2020.

Major players in the market are focused on approval and launch of products to expand their product portfolio. For instance, in November 2018, Polytech Health & Aesthetics GmbH received the CE Mark for Polytech and B-Lite breast implants for another five years.

Regulations

U.S.

The required post-approval studies for silicone gel-filled breast implants are as follows:

Core Post-Approval Studies (Core Studies) – To assess long-term clinical performance of breast implants in women that enrolled in studies to support premarket approval applications.
Large Post-Approval Studies (Large Studies) – To assess long-term outcomes and identify rare adverse events by enrolling more than 40,000 silicone gel-filled breast implant patients and following them for 10-years.
Device Failure Studies (Failure Studies) – To further characterize the modes and causes of failure of explanted devices over a 10-year period.
Focus Group Studies – To improve the format and content of the patient labeling.
Annual Physician Informed Decision Survey (Informed Decision Study) – To monitor the process of how patient labeling is distributed to women considering silicone gel-filled breast implants.
Adjunct Studies – To provide performance and safety information about silicone gel-filled breast implants provided to U.S. women from 1992-2006, prior to approval, when implants could only be used for reconstruction and replacement of existing implants.
Global Breast Implants Market: Competitive Landscape

Major players operating in the global breast implants market include, Allergen, Inc., Mentor Worldwide LLC, GC Aesthetics Plc, Sientra, Inc., POLYTECH Health and Aesthetics GmBH, Establishment Labs S.A., LABORATORIES ARION, HANSBIOMED Co. Ltd., Groupe Sebbin SAS, GG Biotechnology Ltd, CollPlant Holdings Ltd., Cereplas, and PS Technology Development Limited.

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Global Breast Implants Market: Key Developments

Major players in the market are focused on adopting M&A strategies to expand their product portfolio. For instance, in November 2019, Sientra, Inc., a medical aesthetics company, acquired FDA-approved silicone breast implant manufacturing operation from Lubrizol Life Science.

Players in the market faced product recalls. For instance, in July 2019, Allergan, Inc. recalled Biocell textured breast implants and tissue expanders, owing to the link of textured breast implants to a rare type of cancer called anaplastic large-cell lymphoma.

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