Safety of Copolyamide Filler Injection for Breast ...

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Our clinical findings, whether intraoperative or through NMR, reflect that copolyamide fillers induce similar complications as PAAG fillers and contain identical ingredients. Therefore, the risks associated with using copolyamide fillers for breast augmentation are parallel to those observed with PAAG fillers. We strongly advise against the use of copolyamide fillers until their long-term safety is conclusively demonstrated.

Among 29 female patients (average age 42 years), 17 experienced breast deformity, while 8 had infections at the puncture site and inflammation of the mammary glands. Five patients showed induration (both large and small lumps). In four cases, the filler relocated outside the breast to areas like the back and vulva, resulting in severe symptoms. NMR scans indicated that the copolyamide and PAAG fillers produced characteristic PAAG peaks.

All patients who consulted our hospital from 2018 to 2020 due to concerns or complications related to copolyamide fillers were examined. We recorded the filler formulation, observed complications, and intraoperative findings. Copolyamide fillers were analyzed and compared with PAAG fillers (specifically Amazingel and Aquamid) through NMR testing.

Despite the widespread use of copolyamide fillers like Aquafilling/Los Deline and Aqualift/Activegel for breast augmentation, multiple complications have been documented. A recent statement from a Korean aesthetic/reconstructive breast surgery society noted that these fillers are compositionally similar to polyacrylamide gel (PAAG), which is largely banned due to its complications. This retrospective cohort study investigated the complications following breast augmentation using copolyamide fillers. In addition, we conducted nuclear magnetic resonance (NMR) analysis to compare copolymer and PAAG fillers.

Although the position statement made claims, a formal examination of the similarities and differences in complications from copolyamide fillers and PAAG fillers was missing. At Nippon Medical School in Tokyo, Japan, our outpatient clinic specializes in addressing sequelae after cosmetic surgery. We, therefore, have considerable experience managing the aftereffects of PAAG fillers such as Aquamid and Amazingel. This article aims to detail the commonalities and differences between PAAG fillers and copolyamide fillers through a retrospective analysis of patients treated for copolyamide filler sequelae over 27 months from 2018 to 2020. We also determined the composition of these products via NMR analysis.

However, the safety of these products remains a contentious issue due to numerous case reports of complications that include mastalgia, gel migration, inflammation, infection, and nodular lesions. Concerns over these products led the President of the Korean Academic Society of Aesthetic and Reconstructive Breast Surgery to assert that copolyamide filler Aquafilling/Los Deline is chemically identical to polyacrylamide gel (PAAG), based on documents submitted by Biomedica to the Korean FDA. Given the documented serious complications associated with PAAG fillers like localized lumps, deformities, infections, gel migration, and breastfeeding difficulties, the President strongly opposed their use for breast augmentation until their safety is established long-term.

Aquafilling (Biomedica, spol, s.r.o., Czech Republic), developed in 2005 for facial contouring, is a hydrophilic gel composed of 98% sodium chloride solution (0.9%) and 2% copolyamide. In 2018, it was marketed under the name Los Deline (Bio Trh, s.r.o., Czech Republic). Aqualift (National Medical Technologies Center Co., Ltd., Ukraine), similar in composition, was copyrighted in 2013 and renamed Activegel in 2015.

Using NMR spectroscopy, we analyzed Aquafilling/Los Deline and Aqualift/Activegel, and compared the results with our in-house database for PAAG and other PAAG formulations like Amazingel and Aquamid. Despite differences in product names, NMR data revealed that all fillers shared characteristic PAAG peaks, indicating compositional similarity.

This retrospective cohort study involved 29 patients who visited our hospital between January 2018 and March 2020 due to complications or concerns about breast augmentation using copolyamide fillers. Examined data included age, sex, filler type, observed complications, and the treatments administered.

When collecting samples for the NMR study, a new formulation of Aqualift 50 g was opened to extract 1 mL. After storing the remaining product at room temperature for around 3 months, it solidified into a hard resin, weighing just 1.19 g due to evaporation.

NMR spectra for the copolyamide fillers were compared against existing PAAG data. The spectral analysis confirmed that fillers like Aquafilling/Los Deline and Aqualift/Activegel have compositions nearly identical to those of PAAG and PAAG fillers.

Three patients reported chronic breast pain at 34, 38, and 33 months post-injection, respectively. Seventeen of the 29 cases complained of breast deformity, and 8 cases involved infections that spread to the entire mammary gland. Induration was observed in 5 cases, manifesting as either large or small lumps. Although filler migration was less common (4/29), these cases exhibited severe symptoms, with the filler migrating to regions like the back and vulva.

Seven patients were asymptomatic but sought consultation due to media reports on the safety concerns of copolyamide fillers. The average injected volume was roughly 141 grams for the left breast and 139 grams for the right breast, with a time span of 0.5 to 48 months between injection and hospital visit.

Among the 29 patients treated over the study period, all were female, with an average age of 42 years. One patient had both Aquafilling/Los Deline and Aqualift/Activegel fillers, while 24 had Aquafilling/Los Deline, and 5 had Aqualift/Activegel.

This 32-year-old woman had Aquafilling/Los Deline injections in both breasts. Discomfort in her left ribs and bulging in her abdomen led to the discovery of filler migration. A CT scan showed low-density areas, and removal was achieved through subcutaneous cleaning.

This 26-year-old woman had both Aquafilling and Aqualift injections, resulting in breast deformity and filler migration to the vulva. Despite expelling some filler herself, surgery might be necessary to remove the remaining material.

A 35-year-old woman with Aqualift injections developed infections and persistent filler presence under her mammary glands and muscle fibers. CT scans guided a successful removal surgery, improving her condition.

Discussion

PAAG was developed in Ukraine in 1997 and introduced to China under the name Interfall. Despite its popularity, complications led to a ban by the China Food and Drug Administration in 2006. Studies estimated significant complication rates in Chinese patients who received PAAG fillers, including lumps, pain, infection, and deformity. Unukovych et al. reported that 80% of 45 Ukrainian patients treated for PAAG complications experienced pain, breast hardening, deformity, lumps, and fistulas.

Our findings align with these reports. Among 29 patients treated for copolymer-filler complications, 59% had deformity, 28% had infections, and gel migration, induration, pain, and fistula were also observed. The mean time between injection and consultation was 1.8 years.

NMR analysis supported the compositional similarity between copolyamide fillers and PAAG, indicating shared risks. Given the widespread use of NMR for identifying substances, this evidence is reliable.

Main Complications

Deformity and Infection

The most frequent issue was breast deformity, observed in 59% of patients. Infection was the second most common problem, occurring in 28% of cases, some immediately post-injection, others years later. These infections were likely due to improper injection techniques or cannula placement.

Filler Migration

While previously assumed stable, PAAG is now known to migrate, as does Aquafilling/Los Deline. In our study, 14% of cases showed filler migration, complicating treatment. Similar migration issues are reported for PAAG fillers, debunking claims of their stability.

Studies in rats comparing PAAG with hyaluronic acid-based fillers revealed that PAAG's tissue affinity leads to incomplete encapsulation and prolonged inflammation, aligning with our migration cases. These findings suggest that filler migration results from unstable encapsulation and tissue integration.

Filler migration remains a challenge in breast augmentation, but also in other areas such as facial injections or buttock fat injections.

Permanence of Copolyamide Fillers After Injection

Our observations showed that copolyamide fillers solidify and retain their structure after water evaporation, confirming their permanence post-injection. Their non-absorbability implies long-term clinical risks, shared with PAAG fillers. Non-absorbable fillers like silicone also show similar risks, but even absorbable hyaluronic acid fillers can cause adverse events.

Long-term persistence of migrated material necessitates complex removal procedures and can complicate mammography for breast cancer, confirming the high risk of copolyamide fillers. They should not be used until their long-term safety is assured.

Study Limitations

This study has limitations, including the exclusion of some PAAG filler types and focusing only on composition. Further research is needed to confirm the safety of copolyamide fillers. Additionally, systemic inflammatory diseases were not tested in this cohort, leaving questions about their potential to induce conditions like ASIA.

Despite these limitations, our findings highlight the risks associated with copolyamide fillers, emphasizing the need for safer breast augmentation procedures and materials.

A breast lift (mastopexy) is a surgical procedure designed to combat sagging by removing excess skin and tightening the breast tissue. This procedure results in a more youthful and contoured breast appearance.

According to the American Society of Plastic Surgeons, surgical breast lifts have surged by 70 percent since 2000, now surpassing other surgical breast enhancements such as implants.

Despite the rising popularity of surgical options, many patients are now seeking nonsurgical breast lift alternatives.

Nonsurgical breast lifts eliminate the need for cuts, incisions, or general anesthesia.

Nonsurgical methods are considered safer as they avoid risks associated with surgical mastopexies such as:

• infection
• bleeding
• scarring

While nonsurgical breast lifts may not yield as dramatic results as traditional procedures, they offer an option with less risk and cost for those desiring a gentler lift.

Below are 11 nonsurgical breast lift options to discuss with a dermatologic or cosmetic surgeon.

1. Aptos Threading

The Aptos threading technique physically lifts breast skin using small, barbed threads. Inserted beneath the skin with a hypodermic needle, the threads are secured and pulled upwards, toward the collarbone. This noninvasive procedure, also known as the "breast feather lift," provides results lasting up to 2 years.

Average Cost

The average cost of an Aptos thread lift is $2,250, according to a RealSelf survey.

2. Caci Bust Treatment

Initially developed for muscle injury rehabilitation, the Caci bust treatment uses a handheld device to apply electric pulses to chest muscles, resulting in a lifting effect. Multiple sessions over a period are usually necessary to achieve desired results.

Average Cost

A package of Caci treatments can amount to $2,000.

3. Laser Treatments

Laser therapy, using high-energy beams to increase collagen production and remove dead skin cells, can temporarily enhance skin elasticity in the chest area, but the effects are limited and continuous treatments are required.

Average Cost

A standard laser treatment costs between $1,144 and $2,071.

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4. Thermage

Thermage tightens collagen fibers using radio waves, helping enhance breast contours temporarily. A session involves a device called ThermaCool to apply radio waves to deeper skin layers.

Average Cost

The average price for a Thermage session is $1,802.

5. The Renuvion/J-Plasma Device

The Renuvion/J-Plasma technique uses cold plasma energy for skin tightening and collagen production, producing quick results with just one treatment. This method improves natural breast contours while maintaining a minimally invasive nature.

Average Cost

This treatment ranges from $3,000 to $15,000, reflecting its new technological approach.

6. Vampire Breast Lift

The Vampire Breast Lift (VBL) utilizes platelet-rich plasma (PRP) from one's blood to enhance breast appearance and blood circulation temporarily. While not suitable for pregnant or breastfeeding women, or those with a history of breast cancer, it can achieve subtle, push-up bra-like effects.

Average Cost

A VBL costs an average of $1,700.

7. Botox Injections

Botox injections help relax chest muscles to offer minor breast lifting effects. Although not FDA-approved for breast lifting, it can temporarily relieve slouching shoulders, lasting up to four months.

Average Cost

A Botox treatment costs around $376.

8. Dermal Fillers

Dermal fillers, like hyaluronic acid-based Juvéderm and Restylane, offer temporary breast lifting effects by stimulating collagen production. Sculptra, a poly-L lactic acid filler, is typically used for several treatments to achieve results.

Average Cost

The cost per syringe of HA-based filler is about $682, with total costs varying based on the number of syringes used.

10. Try a New Bra

Bras provide essential support and can enhance breast appearance. Investing in a well-fitted bra can be an affordable and effective option for preventing sagging and enhancing lift.

11. The Skinny on Skin Creams

Anti-aging creams for the chest can improve skin firmness and texture but won’t provide significant lifting effects. They can make the skin look firmer and feel softer while reducing fine lines.

Complications

Even nonsurgical methods can cause side effects like irritation, redness, bruising, or discomfort. These complications are usually temporary, but persistent issues should be checked by a doctor.

Temporary Irritation

Some nonsurgical breast lifts may cause temporary irritation, with redness, bruising, or pain lasting a few days. For example, Aptos threading might lead to immediate redness, while Caci treatments could cause muscle soreness. Extended irritation should be discussed with a physician.

Botox-Related Complications

Botox treatments can result in minor bruising, tiredness, soreness, swelling, or allergic reactions, which are typically short-lived. Any concerning symptoms should be promptly addressed with a healthcare provider.

Muscle Injury

Excessive chest exercises can lead to muscle strains or injuries. Balanced and moderate exercise routines are recommended to prevent such issues.

Takeaway

Nonsurgical breast lifts offer less dramatic results than traditional surgeries but provide a viable alternative for those seeking milder enhancements without surgical interventions. Consulting a certified plastic surgeon can help determine suitable options.

For more information or Hyaluronic Acid Filler Price inquiries, feel free to contact us.