If you’ve seen the recent news coverage on breast implants, you might be feeling overwhelmed, confused about certain terms thrown your way, or even questioning if a breast augmentation or reconstruction with implants is worth it, or even safe for your body.

So, are breast implants safe? Let’s clear the air.

Most of the negative news has to do with complications primarily associated with certain implant surfaces or shells in older generations of breast implants. The shell is the envelope that keeps the filling inside the implant, and its surface has direct contact with the body’s tissues when implanted.

Textured shells, which are from the 80s, are created by dipping the shell in either salt or sugar or coating them with polyurethane (PU) before being dried and filled with saline or silicone gel – these processes are precisely what create texture on a shell. Unfortunately, such processes also make the final texture very irregular. Irregular surfaces are associated with more bacterial growth and the formation of hard, fibrous biofilm around the implant.

Some amount of capsule/biofilm formation is a normal reaction by our immune system to create tissue that isolates foreign objects from the rest of our body. But excess bacteria and biofilm can lead to issues such as capsular contracture (which is when the fibrous capsule becomes so hard and thick that it squeezes the implant, sometimes causing pain and/or distorting the breast shape).

 

 

Another complication often linked to textured implants is BIA-ALCL (breast implant-associated anaplastic large cell lymphoma). Different from breast cancer, BIA-ALCL is a rare cancer of the immune system that can develop in the fluid between the implant and the surrounding capsule.

Other complications you might have heard of, like implant rippling, rupture or leakage, are often associated with traditional smooth surfaces, which date back even further – the 60s.

 

 

But there is good news in the middle of all this. In the same way fashion and technology have evolved over the years, so too have breast implants. While several regulatory agencies across the world have recommended the use of smooth implants, it’s important to know that not all smooth surfaces are created equal.

Like with anything else, when we continuously use outdated items in the present, it can cause problems for us down the road. Through observing industry trends and years’ worth of research on implant surfaces and the human body’s reaction to them, we’ve noticed that these issues in the older (4th and 5th) generations of breast implants can be corrected or improved.

You might be wondering how Motiva® is any different. What kind of evolution makes Motiva® the 6th generation of breast implants?

 

 

With SmoothSilk®, your body doesn’t react the same way as it does to other implants. SmoothSilk® is our unique biocompatible surface, designed to minimize irritation and inflammation, which in turn minimizes the risk of capsular contracture and BIA-ALCL. Motiva SmoothSilk® comes with an overall complication rate of less than 1%.

Another unique feature to Motiva Implants® is BluSeal®, which is a barrier layer all around the implant with a light blue biocompatible tint that allows surgeons to visually confirm the barrier layer’s integrity, meaning they can easily see that the implant doesn’t have manufacturing errors in its shell. A uniform, intact barrier layer prevents gel leakage from the implant’s shell. With BluSeal®, Motiva® is the only implant in the world with a barrier layer that can be visually confirmed.

And finally, all Motiva Implants® are covered by the Always Confident Warranty® against rupture, and by our Product Replacement Policy against Baker Grades III and IV of capsular contracture for a period of 10 years. We also offer Extended Warranty Programs for 2 or 5 years, depending on whether your implants include Qid®, an optional digital passport we offer patients for instant, non-invasive retrieval of important information about their implant(s).

These, and other safety features, are what make Motiva Implants® a smart, beautiful choice.

Know that Motiva® is not just another brand of breast implants – it is one that puts women’s health first, and after nine years on the market and more than 800,000 implants sold globally, our community has proudly grown to over 500,000 patients.

We hope you now have all the information you need about Motiva Implants® to make a confident decision for yourself.

September 26, 2019

Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health in breast surgery. Women are at the center of everything we do at Establishment Labs and it is our mission to protect their health by offering safe solutions in breast aesthetics and reconstruction. Based on those principles, a decade ago we began conducting research in conjunction with a risk analysis of breast implant safety, ultimately deciding never to manufacture macrotextured breast implants.

On September 26, 2019, the Therapeutic Goods Administration (TGA) in Australia confirmed that Motiva Implants® will not be affected by their investigations and the subsequent regulatory action announced in relation to breast implants and breast tissue expanders sold in Australia. As part of the new TGA requirements, Establishment Labs will provide additional information to practitioners and consumers in Australia and report of adverse event for all of our breast implant and tissue expander devices sold globally.

Motiva Implants® are clearly differentiated from any other available traditional breast implants. Our SmoothSilk® / SilkSurface® shell is classified in the smooth category according to ISO-14607:2018 “Non-active surgical implants – Mammary implants – Particular requirements”, Annex H, Test for surface characteristics, which we had confirmed by independent testing conducted by Laboratoire National de Métrologie et d’Essais (LNE), a renowned third-party laboratory based in France. TGA’s recent announcement is further affirmation of Motiva’s differentiation.

We offer the most comprehensive portfolio of advanced smooth implants, which incorporates our proprietary SmoothSilk® / SilkSurface® nanosurface technology, which has been designed to minimize inflammation and maximize biocompatibility. This is one of just many safety features that we have built into our Motiva Implants® to improve patient safety and aesthetic outcomes.

Our entire portfolio of Motiva Implants® remain available in Australia and across more than 75 countries worldwide.

For additional information about our advanced product portfolio and breast implant safety features, please visit: motiva.health

Read our complete position statement on breast implant safety here.

July 15, 2019

Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health in breast surgery. Women are at the center of everything we do at Establishment Labs and it is our mission to protect their health by offering safe solutions in breast aesthetics and reconstruction. Based on those principles, a decade ago we began conducting research in conjunction with a risk analysis of breast implant safety, ultimately deciding never to manufacture macrotextured breast implants.

As a result, the Therapeutic Goods Administration (TGA) in Australia has confirmed that supply of Motiva Implants® will not be affected by their investigations.

Motiva Implants® are clearly differentiated from any other available traditional breast implants. Our SmoothSilk® / SilkSurface® shell is classified in the smooth category according to ISO-14607:2018 “Non-active surgical implants – Mammary implants – Particular requirements”, Annex H, Test for surface characteristics, which we had confirmed by independent testing conducted by Laboratoire National de Métrologie et d’Essais (LNE), a renowned third-party laboratory based in France. TGA’s recent announcement is further affirmation of Motiva’s differentiation.

We offer the most comprehensive portfolio of advanced smooth implants, which incorporates our proprietary SmoothSilk® / SilkSurface® nanosurface technology, which has been designed to minimize inflammation and maximize biocompatibility. This is one of just many safety features that we have built into our Motiva Implants® to improve patient safety and aesthetic outcomes.

Our entire portfolio of Motiva Implants® remain available in Australia and across more than 70 countries worldwide.

For additional information about our advanced product portfolio and breast implant safety features, please visit: motiva.health

Read our complete position statement on breast implant safety here.

Since their inception in the mid-60s, surgery with silicone gel breast implants has consistently been one of the most commonly performed cosmetic procedures in the world – and yet, the devices have seen relatively little evolution by their most prominent manufacturers in the last 50 years.

1st  Generation

While breast implants have existed since the late 19th century, they weren’t made of silicone or saline until the 1960s. Previously used materials have included ivory, glass, ox cartilage, ground rubber, and polyester.

Injections with raw, liquid silicone were received by an estimated 50,000 women before surgeons and manufacturers realized that the silicone needed to be housed in barrier shells to keep it from entering the bloodstream and causing disastrous side effects.

In 1961, American plastic surgeons Frank Gerow and Thomas Cronin partnered with Dow Corning Corporation produced the first shelled, silicone gel-filled breast implant, which was first used surgically the following year.

This first generation of silicone breast implants were characterized by Dacron patches (made of a synthetic form of polyester), thick (roughly 0.25 mm) shells, and thick and viscous silicone gel.

Quickly becoming popular despite controversy around the practice of breast augmentation, this initial generation was manufactured until the early 70s and was often associated with capsular contracture (i.e. the formation of a hard, fibrous capsule that contracts the implant within itself) and implant rupture.

2nd Generation

The second generation were introduced a decade after the first, with implant shells thinned to nearly half their thickness and thinner, more liquid-y gels used to give the implants a softer feel. But these changes, along with stopping the use of Dacron patches, did not help in addressing high rates of capsular contracture.

3rd Generation

Thick, silica-reinforced shells (the likes of which can still be found in fourth and fifth generations) characterize this generation in manufacturers’ attempts to make breast implants stronger. Unfortunately, the thinner, syrupy gel that was used as filling would bleed much farther into the bloodstream when these shells became compromised.

This generation was marked by controversy and fear around the use of silicone breast implants during the 80s and 90s.

In 1992, the US FDA called for a moratorium on silicone gel breast implants due to concerns that this generation posed more of a health risk than previously thought. This moratorium ended up staying in effect until 2006, when the FDA approved a fourth generation of silicone “responsive gel” implants.

PIP, a large French implant manufacturer, also became embroiled in a prominent scandal and was eventually liquidated in 2010 due to their use of unapproved, non-medical-grade silicone gel. 

4th & 5th Generations

It’s no coincidence we address fourth and fifth generations simultaneously, as the only significant changes they heralded were related to silicone gel cohesivity.

In the 90s, shells were further strengthened, and more cohesive versions of silicone gel were used to minimize complications related to gel leakage. Because these cross-linked silicone gel molecules retain their form (retaining their shape even when cut), such filling is not likely to “bleed” or ooze if the shell breaks down.

The fourth generation is associated with the responsive gel implants that the FDA cleared in 2006 (which is most common in round implants and has moderate cohesivity), while the fifth is associated with the more highly form-stable gels that characterize “gummy bear” implants. Highly cohesive form-stable implants are typically made in a teardrop or anatomical shape, with greater lower pole fullness and a sloping upper pole.

But “gummy bear” form stability has proven to be both a blessing and a curse, as patients have complained the 5th generation implants look and feel stiff and unnatural, especially when lying down.

6th Generation Motiva Implants®

Unfortunately, the silicone implants available from most large manufacturers today are not very different from the versions sold in the 90s. Capsular contracture, rupture, seromas, and even breast implant-associated cancer (known as breast implant-associated anaplastic large cell lymphoma, or simply BIA-ALCL) continue to be issues that plague breast implant recipients.

Recognizing this industry-wide complacency in implant safety, Establishment Labs® has taken a patient-centric approach in developing and incorporating revolutionary technologies in its Motiva® products to maximize both safety and aesthetic outcomes.

Motiva Implants® possess several patented, first-of-their-kind features that have disrupted the breast implant industry. Each feature was incorporated to minimize safety concerns that previous and current implant manufacturers have failed to adequately address. These include:

  • BluSeal®: a visual indicator that allows for 100% confirmation that a barrier layer is intact, to minimize any risks of gel bleed
  • Qid®: a passive RFID microtransponder system for non-invasive, immediate traceability and verification of implant information, including potential recall
  • Ergonomix®: These premium Motiva Implants® are manufactured with ProgressiveGel™ Ultima, a proprietary silicone gel that provides the most natural look, feel, AND movement, whether a patient is standing, in motion, or lying down
  • TrueMonobloc®: Special attention has been paid to providing all Motiva Implants® with uniform tensile strength (i.e. equal performance under stress at any point on the implant) by chemically bonding the implant gel, shell, and patch – thus, they are designed to prevent implant rupture

A Brief Note on Saline Implants

Saline implants were first introduced into the breast implant market in 1964. While the earliest saline implants were associated with high rates of deflation, design modifications to their shells have allowed a significant delay in when eventual deflation may occur. They briefly became more popular in the North American market as an alternative to silicone-filled implants during the FDA moratorium between 1992 and 2006. Today, however, silicone gel implants comprise most devices used in breast augmentation surgery, owing to the clinical efficacy and safety of newer-generation models, as well as the inevitable deflation of saline implants. Silicone gel implants are also far more popular among patients because of their significantly more natural look and feel.

To learn more about the Motiva® range, feel free to browse our website, contact a MotivaImagine Center® or Partner surgeon/clinic, or contact us directly.