Breastfeeding with a gel implant of Polypropylene Acylamic Liquid Gel

[Lyndel Fuller]

Dear Mr Hale,

I am emailing you in regards to a client I am seeing who had Breast Augmentation in China in 2002, with an injection of polypropylene acylamic liquid gel.
Shuang had this removed 2 years ago via surgery but the doctor said he was only able to take 95% of the gel out.
The question is , can Shuang breast feed with the remaining 5 % in, as she has been told that the product is banned in Australia and recently been banned in China. Shuang had the operation in China.
I wasn’t able to find any information out in your current book, and unable to find out much when I tried to google this.
Are you able to give us more information on this and get back to us as soon as you can.
Shuang is due to have her baby on July 7th, pregnancy going well at the moment.

Kind Regards,
Lyndel Fuller
Lactation Consultant
Breastfeeding Support Centre
Mater Mothers Hospital
Brisbane
Phone 07 31638200

[admin]

Lyndel:

We've had a number of calls about this polyacrylamide hydrogel injection method used in China. The research suggests that it might increase tissue rejection and inflammation, and even migrate out of the breast into shoulder areas. As a method for breast enlargement, it should be totally rejected and never used today.

There are quite a few papers on this gel in PubMed (see below for a starter). That said, some of it, particularly the lower molecular weight polymers still present in tissues after a while might indeed enter the milk compartment. I really doubt any of it would be orally absorbed by an infant, and it would probably just pass out in the stool, unabsorbed. This gel is used because it is highly inert, and largely resistant to breakdown in the tissues. This would suggest that it is probably of minimal risk "orally" to an infant.

I doubt that 1) levels will be high in milk, or 2) that it is of a major risk to a breastfeeding infant. But this is just a guess on my part. I am not well versed in this material and maybe some toxicologist out there can provide better information.

Tom Hale Ph.D.

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Aesthetic Plast Surg. 2005 Jan-Feb;29(1):34-48. Epub 2005 Mar 11.
Adverse reactions to injectable soft tissue permanent fillers.
Christensen L, Breiting V, Janssen M, Vuust J, Hogdall E.
Source
Department of Pathology, Rigshospitalet Fred., Copenhagen, Denmark. liserh01870christensen@rh.dk
Abstract
BACKGROUND:
Synthetic injectable facial fillers with a permanent effect are widely atoxic and nonimmunogenic, but they differ with respect to composition and in chemical and biologic characteristics. Yet, they all act as foreign bodies in the tissues eliciting a host response that try to remove the gel. Inflammatory nodules may develop at the sites of injection-for some fillers, many years later, for others, not. Why is that?
METHODS:
Biopsies were contributed by various plastic surgeons from Europe and Australia after requests were made at international congresses and workshops. The study was based on (a) 5 biopsies from unreactive tissue obtained at different times after injection of polyacrylamide hydrogel (Aquamid); (b) 28 biopsies from intermediate or late inflammatory nodules after injection of polyacrylamide hydrogel (Aquamid) (20 cases), a hyaluronic acid-polyhydroxyethylmethacrylate/ethylmethacrylate gel (Dermalive) (2 cases), and a gel consisting of polylactic acid in mannitol/carbomethoxycellulose (New-Fill) (6 cases); and (c) a review of the literature on adverse reactions after injection with permanent fillers.
RESULTS:
Clinically unreactive tissues after injection with Aquamid showed modest or no host reaction. Inflammatory nodules showed an increased foreign body reaction and a bacterial infection after injection with Aquamid, and a combination of moderate foreign body reaction, fibrosis, and in some cases also bacterial infection after injection with Dermalive and New-Fill. According to the literature, inflammatory nodules occur no later than 1 year after injection with polyacrylamide hydrogel, but up to 6 years after injection of combination gels (Artecol), and up to 28 years after injection of silicone gel.
CONCLUSIONS:
Inflammatory nodules are likely to be caused by a low-grade infection maintained within a biogfilm surrounding the hydrophobic silicone gel and the combination gels. Aquamid gel may prevent formation of a biofilm through its high water-binding capacity, explaining why late inflammatory nodules are not seen after injection of this polyacrylamide hydrogel product.
PMID: 15759096 [PubMed - indexed for MEDLINE]


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Plast Reconstr Surg. 2003 May;111(6):1883-90.
Long-term effects of polyacrylamide hydrogel on human breast tissue.
Christensen LH, Breiting VB, Aasted A, Jørgensen A, Kebuladze I.
Source
Department of Pathology, Rigshospitalet, Copenhagen, Denmark. liserh01870christensen@rh.dk
Abstract
Polyacrylamide hydrogel is an atoxic, stable, nonresorbable sterile watery gel consisting of approximately 2.5% cross-linked polyacrylamide and nonpyrogenic water. Polyacrylamide hydrogel is widely used in ophthalmic operations, drug treatment, food packaging products, and water purification. In the former Soviet Union, polyacrylamide hydrogel has been used in plastic and aesthetic surgery for more than 10 years, and Kiev City Hospital treats approximately 300 women a year for breast augmentation using the polyacrylamide hydrogel Interfall (Contura SA, Montreux, Switzerland). Capsule shrinkage following these injections has never been observed. The authors examined breast tissue samples from a total of 27 women who had polyacrylamide hydrogel injected at Kiev City Hospital up to 8 years and 10 months earlier. Age at operation, duration of polyacrylamide hydrogel implantation, history of possible side effects to the gel injection, other intercurrent diseases, the reason for present open breast operation, and breast palpation findings before operation were in each case compared with the histological findings on samples taken from breast tissue bordering the gel. The gel presented itself as a dark violet, homogenous mass with a rounded or ragged outline in large or medium-size deposits and as elongated strands, which mimicked the extracellular matrix, in small deposits. Histological findings of the breast tissue bordering the gel showed three different patterns: large collections of gel gave rise to a thick, soft-looking cellular membrane of macrophages and foreign-body giant cells; medium-size deposits were surrounded by just a thin layer of macrophages; and small deposits were not associated with any reaction in the surrounding tissue. Projections of the cellular soft membrane, known as granulomas, were seen in six patients. The granulomas were composed of macrophages, foreign-body giant cells, lymphocytes, and blood cells. A thin layer of fibrous connective tissue was occasionally present around the foreign-body membrane, but the thick fibrous capsule, which has been described in connection with silicone implants, was completely absent. The gel changes could be correlated to neither time since gel injection nor a history of recent injury or inflammation. It is concluded that the polyacrylamide hydrogel Interfall, which has been used in the former Soviet Union, is stable over time, nondegradable, confined to the breast, and diffusion and migration resistant. When the hydrogel is injected in medium-size or large quantities a cellular foreign-body reaction occurs, but in small amounts it is capable of splitting up individual connective tissue fibers and fat cells, substituting for the extracellular connective tissue matrix without eliciting any foreign-body reaction. As far as these data are concerned, polyacrylamide hydrogel is well tolerated by the breast and does not give rise to severe fibrosis, pain, or capsule shrinkage. However, to determine safety with more certainty, a larger sample size would be necessary.
Comment in
Plast Reconstr Surg. 2004 May;113(6):1878; author reply 1878-9.
PMID: 12711948 [PubMed - indexed for MEDLINE]

[boorakg]

Dear Mr Hale,
I am a GP working in Melbourne in Australia.I have recently seen a patient who has had injection of a liquid gel into her both breasts in Iran almost 10years ago.She has never had any complications from them.I suspect that the product used in Iran in those days might have been the Polyacrylamide hydrogel as well.
She has presented to me for antenatal care,and she is very keen to breastfeed.I know you have mentioned that it is probably safe to breastfeed but is it also safe on the fetus if that product is present in mother's system?
Kind regards
Bahareh

[boorakg]

Breastfeeding with PAAG

Dear Mr Hale,
I am a GP working in Melbourne in Australia.I have recently seen a patient who has had injection of a liquid gel into her both breasts in Iran almost 10years ago.She has never had any complications from them.I suspect that the product used in Iran in those days might have been the Polyacrylamide hydrogel as well.
She has presented to me for antenatal care,and she is very keen to breastfeed.I know you have mentioned that it is probably safe to breastfeed but is it also safe on the fetus if that product is present in mother's system?
Kind regards
Bahareh

[cpride]

Dear Bahareh,

No studies were found on the effects of polyacrylamide hydrogel during pregnancy. This polymer has been implicated in causing such adverse events as local infection and inflammation and has been known to migrate to different areas of the body. These adverse effects would not likely effect a fetus, but there may yet be unknown factors.

Sincerely,
Cindy Pride, MSN, CPNP
TTUHSC InfantRisk Center

[tali]

Hi
I am breathfeeding a 6.5 month baby. On 17 oct i did wrinkle treatmet in the face
1. Botox allergan 20u (forehead)
2. Hyaluronic acid 1ml "princess" (for the smile wrinkles near the mouth)
I have been told it is safe will breathfeeding and continue breathfeeding immediately without any stop. Few days ago I found out that in Holland for instance after botox mother do not breathfeed for 4 weeks.
Is it possible to check my milk to find out if it is free from those materials? Since 24 to oct i do not breathfeed, I pump out the milk and did not give it to my daughter
Thank You
Tali

[admin]

Tali:
Botox is not absorbed significantly from the tissues where it is injected. Hence you never find it in the plasma compartment in measurable amounts. Hence, you're not going to see it in breastmilk either, as it is too large to enter the milk compartment. I see no problem with breastfeeding at all, as long as your use the "Botox" brand and not some generic product. It would not realistically be possible to measure it in your milk.

Tom Hale PH.d.

[miraabc]

Dear Dr. Hale, I understand your point on Botox and breastfeeding, then how about hyaluronic acid injection while breastfeeding or pregnancy, any problems? Thank you!

[admin]

Miraabc:

Hyaluronic acid forms a viscoelastic solution in water, thus functioning as a joint lubricant, vitreous humor during opthalmic surgery, and even decreasing the depth of wrinkles when injected intradermally. Sodium hyaluronate is a polysaccharide commonly found in humans in the extracellular matrix of connective tissues. There are no data available on the transfer of hyaluronic acid into breastmilk, but it would be minimal to nil. The repeating chains can be quite large, and therefore size would prohibit any drug that did get absorbed from transferring into the milk compartment. A similar product is Hyalgan, which is sodium hyaluronate.

Tom Hale Ph.d.