Unveiling breast implants industry in terms of the regulatory landscape: How the enforcement of regulations by governing bodies impacts the market growth
Published Date: November 23, 2017 Author: Saipriya Iyer
Having endorsed itself as an intrinsic realm of the medical devices domain, breast implants industry stands to gain much in the forthcoming years, by virtue of the incredible popularity of this medical technique. The procedure, in fundamental terms, has been commercialized since many years, however, it has garnered widespread acclaim only since the last decade, proportionately more than what has been predicted. The rationale behind the accelerated growth of breast implant market is the growing standards of beauty in the glamor industry, in conjunction with the desire among the female populace to remain fit and youthful. The statistics affirming the aforementioned fact are indeed astonishing – according to the American Society of Plastic Surgeons, the year 2016 registered a total of 290,467 breast implant surgeries, which is an increase of close to 4% from the number of surgeries in 2015. This estimates vividly exhibits the scope of breast implants industry across the United States. The popularity of breast augmentation has also been amply evidenced by the organization’s estimates that in the year 2016, breast augmentation with the fat grafting technique depicted an increase of close to 72%. Gauging the speed by which these surgeries have transpired, it cannot be denied that breast implants industry has indeed emerged to be one of the most remunerative business spheres under the medical devices sector, in recent times. In fact, global breast implants market size, as claimed by a recently undertaken research study, was worth more than USD 3 billion in 2016.
If there is one iota of detail regarding breast implants industry that is obscurely known, it is the fact that this business space is highly driven by regulations. Perhaps, marred by the popularity of the technique and its notoriety across the fashion cosmos, the fact that it is a rather important vertical of the medical devices domain and is overtly subject to regulatory norms has been conveniently circumnavigated. Nonetheless, what remains to be taken note of, is that breast implants industry is indeed characterized by a stringent regulatory framework. In the light of recent scenarios, it would be apt to infer that the backing of administrative bodies is highly critical for breast implants market. The two crucial events affirming the aforementioned statement and validating the prevalence of stringent norms for breast implants industry are sequentially enlisted below.
The catastrophic effects of the notorious PIP health scare on breast implants industry
In the year 2012, the France breast implants market giant, Poly Implant Prothese (PIP), infamously made it to the front page for having distributed defective silicone implants. A couple of years earlier, the firm’s products had nevertheless, been banned from usage, on account of the fact that the company deployed industrial grade silicone fillers in the implants instead of medical grade material, as has been authorized by regulatory bodies. These implants apparently had twice the rupture rate of regular implants – a shocking revelation that led to the product being banned.
However, a couple of years later, it was unearthed that the firm had continued to manufacture defective implants, which consequently led to one of ugliest repercussions that breast implants industry has witnessed in the last decade. In what can only be described as a cataclysmic conjuncture, the owner of the France-based breast implants market firm was imprisoned for fraud, while the German regulatory body that granted safety certificates for the implants was heavily penalized. The event served as a wake-up call for the regulatory authorities across the globe, all of which brought about major changes in the safety norms and legal authorizations that breast implants industry firms would have to follow. In fact, just recently, in May 2017, the European parliament established new regulations for MDR (medical devices), which would most certainly impact the growth path of breast implants industry. The changes would be effected around 2020 – 3 years from the date of publication in the European Official Journal, and all the E.U. member countries would require to collectively comply with the same. The regulation has indeed stemmed from the PIP incident that vividly accentuated the discrepancies and inconsistencies in the legal framework pertaining to breast implants market.
Cancer occurrences due to implants and its impact on breast implants industry
Recently, the U.S. FDA received reports of 9 deaths that have apparently resulted from a rare form of cancer occurring due to breast implants. Referred to as anaplastic large cell lymphoma (ALCL), this cancer affects the cells in the immune system and is apparently detected around the implant. The incident sent shockwaves among breast implants industry giants, having proved FDA’s claim regarding breast implant-associated ALCL cases to be true. Back in 2011, the U.S. FDA declared that ALCL was more likely to occur in women having undergone breast implant surgeries than in women who are devoid of artificial implants. The revelation indeed posed a slight constraint to breast implants market since then, and now, with the news of 9 deaths being linked to breast implants, the resolve of regulatory bodies to tighten the norms surrounding breast implants industry has strengthened further. On that note, as on March 2017, the FDA has updated its understanding of BIA-ALCL, that would require medical experts to scrutinize the implant procedures with greater precision, in addition to monitoring subtle changes in their patients post the surgery.
However, it is noteworthy to mention that a few disastrous incidences notwithstanding, there has not been an extensively deplorable effect on breast implants industry growth so far. Statistics affirmed by the Plastic Surgeon Foundation and the American Society of Plastic Surgeons declare that between 10-11 million women in the world undergo implant surgeries annually, and lesser than 10 among them are diagnosed with breast implant-associated ALCL. Another study demonstrates that merely one amidst 300,000 women with breast implants would be diagnosed with ALCL. These statistics testify a vital case – that breast implants market would continue to traverse along the path of progress. However, it would always remain under the scrutiny of administrative bodies, and breast implant industry firms would require to manufacture products in accordance with norms related to medical safety.
A concise insight into the regulatory landscape of breast implants industry
Silicone gel-filled implants have penetrated the breast implants market since long, in fact, they have pervaded the U.S. belt as early as 1963. More than a decade later, the U.S. FDA was authorized to oversee the amendments related to medical devices, and since then, breast implants industry has witnessed numerous changes in the enactment of norms. A precise summary of the same has been enumerated below:
- In 1976, the U.S. Congress passed a set of laws classified as the Federal Food, Drug and Cosmetic Act, through which the official authority of medical devices was passed on to the FDA. Hereon, breast implants industry was legally under the jurisdiction of the FDA, and the implants were supposed to be reviewed under the 510(k) (premarket notification) process. Somewhere around 1992, breast implants industry underwent the first major transformation when the FDA issued an embargo on product development and implantation, in order to review new safety measures.
- In 1998, the Adjunct Study protocol for Allergan – one of the FDA-authorized silicone gel implants forayed in breast implants industry, was submitted to the organization for approval. While PMAs for the Allergan saline filled implants were approved a couple of years later, the FDA approved the first PMAs for silicone filled Allergan in 2006, post a series of advisory panel meetings. The Mentor MemoryGel, another implant approved by the FDA, also debuted in breast implants industry the same year.
- The year 2011 signified the landmark of an important development in breast implants market, as the FDA issued a Safety Communication regulation on ALCL in women with implants. In the same year, the organization issued an update on the silicone gel-filled implants – Allergan and Mentor, which authorized the respective manufacturers to conduct further studies on the upgraded implants to obtain the approval for the commercialization of the products in breast implants industry.
- In the year 2013, the FDA officially approved the PMAs for upgraded versions of Allergan and Mentor, both of which encompassed a more cohesive silicone gel as compared to their predecessors. As on 2017, the FDA has approved five silicone-gel implants, namely, Sientra’s Silicone Gel Breast Implants, the Allergan Natrelle, Allergan Natrelle 410, Mentor MemoryGel, and the Mentor MemoryShape, to be officially manufactured by breast implant industry players.
It is indeed thoroughly coherent that manufacturers partaking in breast implants market share will have to scrupulously follow the regulations enforced by the FDA and other organizations. The domination of a regulatory framework however, cannot be considered as a factor constraining the growth of breast implants industry, on the grounds that the prosecution of norms solely aims at patient safety and wellness. Manufacturers would need to develop products that are totally in compliance with medical safety standards, for the implants to sustain in the market without the encumbrance of legal and medical violations, which would most certainly boost breast implants industry size. In fact, this transformative trend has already made its mark in this business. Recently, in 2016, when the European regulators issued orders to shut down Sientra’s Brazilian facility, alleging unsafe manufacturing conditions, the company, in accordance with the regulatory standards, signed a contract to use Vesta, a manufacturing unit of Lubrizol LifeSciences, to continue developing implants. The presence of governing bodies and their set guidelines is likely to augment breast implants industry share, projected to surpass a valuation of USD 4.5 billion by 2024.
Global Market Insights, Inc. has a report titled “Breast Implants Market Size By Product (Silicone Implant, Saline Implant), By Shape (Round, Anatomical), By Application (Breast Augmentation, Breast Reconstruction), By End Use (Hospitals, Clinics, Others), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, France, Italy, Spain, Russia, China, India, Japan, South Korea, Australia, Brazil, Mexico, Argentina, South Africa, Saudi Arabia, Egypt), Application Potential, Price Trends, Competitive Market Share & Forecast, 2017-2024” available at https://www.gminsights.com/industry-analysis/breast-implants-market