Silicone gel-filled breast implants have been approved by the US Food & Drug Administration for breast augmentation among women aged over 22 years. Breast reconstruction is also a lucrative area where silicone gel-filled breast implants seek significant demand, along with their use in the revision surgeries that rectify or improve results of the original surgery. Silicone Gel-Filled Breast Implant Market is expected to witness bullish prospects as these are not lifetime devices and are associated with periodic replacements.
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However, frequent complications experience by patients with silicone gel-filled breast implants, including infection, pain, scarring, asymmetry, wrinkling, and implant rupture, along with capsular contracture and reoperation continue to ebb growth of the Silicone Gel-Filled Breast Implant Market. Much attention has been focused on silicone gel-filled breast implants in recent years, with concerns regarding silicone leak into bodies of these implant recipients.
MRI prevails as an effective silent rupture detection method in patients with silicone gel-filled breast implants. Palpability of MRI in the silicone gel-filled breast implant market is complemented by the FDA’s recommendation for MRI screening post-three years of receiving the implant. Although no direct association has been observed between silicone gel-filled breast implants and tissue diseases, reproductive problems, and breast cancer, more research is required for definitively ruling out concerns of these complications.
The FDA required manufacturers of silicone gel-filled breast implants to update their product labelling to include safety information. Update on the Safety of Silicone Gel-Filled Breast Implants by the FDA includes preliminary results of studies needed by manufacturers during approval and review of available scientific data.
Silicone gel-filled breast implants consist of an outer shell made of silicone and filled with silicone gel. The silicone gel is a bit more like natural breast tissue. Silicone gel-filled breast implants are available in different sizes with smooth or textured shells. Generally, silicone gel-filled breast implants are approved for breast augmentation and breast reconstruction surgeries. FDA-approved silicone gel-filled breast implant is for breast augmentation in women aged 22 or older and for breast reconstruction in women of any age.
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Moreover, the implants are also used in revision surgeries which improve or correct the result of an original surgery. Usually, breast implants are not lifetime devices. Adverse and frequent complications experienced by breast implant patients include reoperation, capsular contracture, and implant removal. Some of the other complications include wrinkling, implant rupture, asymmetry, pain, scarring, and infection. Breast implantation surgery increases the probability of being diagnosed with anaplastic large cell lymphoma (ALCL). MRI is considered to be an effective method for detecting silent rupture of silicone gel-filled breast implants.
According to FDA, there are five silicone gel-filled breast implants been approved, namely Allergan Natrelle (approved in November 2006), Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (approved in February 2013), Mentor MemoryGel (approved in November 2006), Mentor MemoryShape (approved in June 2013) and Sientra’s Silicone Gel Breast Implants (approved in March 2012).
According to a journal published in the U.S., it was estimated that around 93,083 breast reconstruction procedures and 296,203 breast augmentation procedures were performed in 2010. In 2015, according to the estimates of the American Society for Aesthetic Plastic Surgery, approximately 47.9% of breast implant procedures were undertaken by women belonging to the age group of 19–34 years in the U.S.
The growth of the global silicone gel-filled breast implant market is driven by increasing prevalence and incidence of breast cancer in the global population. For instance, according to the research conducted in 2017, it is estimated that 1 in every 8 (nearly 12%) women will develop invasive breast cancer over the course of the lifetime in the U.S. alone. Furthermore, population drifting towards aesthetic appearance and increasing disposable income are also driving the growth of the global silicone gel-filled breast implant market. However, the high cost related to breast implantation surgeries and lack of skilled personnel are the major factors hampering the growth of the global silicone gel-filled breast implant market. Most of the cases of breast implants cause health problems as women with implants need additional surgeries to replace or remove their implant. This hampers the growth of the silicone gel-filled breast implant market. In addition, it is also estimated that one in four women who get breast implants will require additional surgery. The cost of removing or replacing breast implants can be higher than the cost of getting implants in the first place.
On the basis of geography, the global silicone gel-filled breast implant market is segmented into six key regions viz. North America, Latin America, Europe, Asia Pacific excluding China, China and the Middle East & Africa. The North America silicone gel-filled breast implant market is expected to hold the large share in the global market, followed by Europe, due to the increasing prevalence and incidence of breast cancer. Moreover, increasing number of cancer surgeries coupled with the presence of sophisticated healthcare infrastructure is also boosting the growth of the silicone gel-filled breast implant market. The silicone gel-filled breast implant market in the Asia Pacific region is expected to grow at a higher rate due to the presence of large population base, and favorable reimbursement scenario. However, the market for silicone gel-filled breast implant in regions such as Latin America, and the Middle East and Africa are estimated to show a stagnant growth over the forecast period. Latin America is expected to gain future opportunities due to the increasing medical tourism in countries such as Brazil, Mexico, and Argentina.
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