Breast implants have come a long way in the last 40 years. In the early 1980s, breast implants were quite different from the silicone and saline implants commonly used today. Let’s take a look at the history and evolution of breast implant materials over the past few decades.
The First Breast Implants – Silicone injections
The first “breast implants” were liquid silicone injections that were directly injected into the breasts during the 1960s. This was an extremely dangerous practice that often led to disfigurement and health issues. Silicone injections resulted in hard, painful lumps and uneven, unnatural-looking breasts. Many women suffered complications like leakage of the silicone into surrounding tissue and infection. The practice was banned by the FDA in the early 1960s due to safety concerns.
Early Silicone Gel-Filled Implants
The first silicone gel-filled breast implants were developed in 1961 by two plastic surgeons – Frank Gerow and Thomas Cronin. The earliest versions had a thick silicone outer shell and were filled with a viscous silicone gel. The first implants had many issues:
- The thick outer shell often contracted and hardened around the implant, causing visible wrinkling and distortion of the breast shape.
- They needed large incisions (5-6 inches long) to implant.
- The thick gel was difficult to control and could leak out of the implant shell.
- High rates of capsular contracture – scar tissue forming around the implant, squeezing it and making breasts painfully hard.
Throughout the 1970s and into the 1980s, implants evolved with thinner shells to reduce wrinkling and scarring. The gels also gradually became less viscous. But complications like leaks, shifting, and capsular contracture remained problematic.
Polyurethane Foam-Coated Implants
In the early 1970s, manufacturers experimented with polyurethane foam coating on the outside of silicone gel implants. The goal was to create a textured, porous surface to integrate better with breast tissue and reduce capsular contracture rates. Some of the early coated implants included:
- Ashley Natural Contour Prosthesis – polyurethane foam coating, 1971
- Surgitek Polyurethane Foam-Coated Implant – 1980s
- Meme or Replicon implant – polyurethane foam coating, 1970s-80s
Though never conclusively proven, concerns emerged in the late 1980s and 1990s about potential health risks from polyurethane breakdown. Most makers voluntarily pulled coated implants off the market by the early 1990s, though uncoated silicone gel implants remained available.
Saline-Filled Implants
The first saline-filled breast implants were introduced in France in 1964. Early versions had silicone rubber outer shells filled with saline solution during surgery. Saline implants offered advantages over silicone:
- Saline is safely absorbed by the body in case of leakage/rupture.
- Saline implants have a smaller incision since they are inserted empty then filled.
- The saline filler can be easily adjusted during surgery for size and symmetry.
However, the main drawback of early saline implants was visible scalloping or wrinkling of the implant edge that could be felt or seen through the skin. Implant technology improved greatly throughout the 1980s and 1990s to create a smoother, more natural look and feel.
Alternative Implant Materials – Past and Present
Besides silicone and saline filling, some alternative implant materials have been developed and used over the years:
| Material | Years Used | Issues/Complications |
|---|---|---|
| Polyvinylpyrollidone | 1960s | High rates of capsular contracture and infection |
| Hydrogel | 1970s-1980s | Gel hardening, shape distortion |
| Soybean oil | 1970s-1980s | Capsular contracture, poor cosmetic results |
| Polyacrylamide gel | 1990s | Toxicity concerns stopped routine use |
Today, gummy bear implants (form-stable silicone gel) and IDEAL silicone implants aim to combine the benefits of silicone filling with reduced risk of leakage and rupture issues. Fat grafting is also growing in popularity as an alternative to implants.
Evolution of Silicone Implant Safety
The silicone implants of 40 years ago were a far cry from the highly engineered silicone devices available today. Some key innovations that have improved silicone implant safety and quality:
- Multi-Layered Shells – Modern silicone implant shells have evolved to be made of multiple layers of silicone elastomer for durability and strength. This helps prevent shell leaks, fractures and reduces gel bleed.
- Cohesive Gel Filling – Highly cohesive silicone gel is less likely to leak out of the implant due to its stable, form-retaining properties.
- Textured Surfaces – Texturing helps the implant adhere to surrounding breast tissue and reduces the risk of rotation, shifting, and capsular contracture.
- Stronger Valves – Self-sealing valves allow silicone implants to be filled during surgery while preventing leakage later on.
- QC Testing – Improvements in manufacturing standards and FDA oversight ensure each device undergoes rigorous quality control testing before being approved.
Today’s silicone implants are engineered for longevity and safety, with devices lasting 10-15 years or longer before potentially needing replacement compared to earlier generations.
Regulation History
The FDA has increased oversight and regulation of breast implants over the decades:
- 1976 – FDA begins regulating breast implants as medical devices and mandates manufacturers meet quality control requirements.
- 1988 – Due to rising safety concerns, the FDA allows silicone implants only for reconstruction and under clinical trials for augmentation.
- 1992 – Silicone implants are restricted to only reconstructive patients enrolled in manufacturer studies.
- 2006 – FDA lifts restrictions and approves new-generation silicone implants from Allergan and Mentor.
- Today – Only rigorously tested implants from approved manufacturers meeting strict safety standards can be marketed.
Conclusion
Breast implants 40 years ago had high rates of complications and poor safety compared to modern devices. Early implants from the 1960s-1980s featured materials like liquid silicone injections, thick polyurethane foam coatings, and viscous silicone gels prone to leakage and rupture issues. High rates of capsular contracture, shifting, and hardness were also commonplace.
Technological developments over the past few decades have led to the safe, effective breast implants available today. Thanks to advances in materials science, stricter regulatory oversight, and implant testing procedures, women can now opt for implants with peace of mind regarding their safety and quality.