Safety of Smooth Walled Saline Breast Implants Confirmed by French Study
31 yo with 300cc saline implants before and 4 months post operative
Many misconceptions about Saline Implants are perpetuated by surgeons, both Plastic and Non-Plastic Surgeons who have little exposure with Saline Implants. Silicone Implants have definitely been in the spotlight mainly due to problems that have occurred with them over the years and the subsequent recalls of these implants. In the meantime, however, Saline Implants have quietly plodded along in the background without recall issues and continue to be used regularly by approximately 30% of Surgeons in the United States.
A recent study by French plastic surgeons has confirmed the safety of smooth saline filled breast implants. The study from Paris, which was published in the April 2020 edition of the Aesthetic Plastic Surgery journal* confirmed this via a long term study that not only were there no cases of lymphoma or seroma in the patient group but there was a very low rate of implant rupture as well as a low rate of capsule formation in these patients who had had smooth walled-saline implants for a period of 10 years or more in some cases.
This study further confirms that smooth inflated saline implants are a very valuable alternative to gel implants. This article is especially timely now that textured gel implants have been banned by health authorities in many countries due to their association with ALCL (anaplastic large-cell lymphoma). To have a retrospective study of nearly 400 patients who were followed for ten years or more after having saline implants inserted can give confidence to the assertion that there is indeed a very low rate of complications and high rate of satisfaction associated with these safe and versatile implants. I
A summation of the findings is as follows:
- Saline Implants had a capsular contracture rate of 5.7% compared to silicone 9.6%.
- Smooth walled Implants had a rupture rate of 3.4% compared with a silent rupture rate In Gel Implants (assessed by MRI) of 17.7%.
- The amount of “Rippling” was the same as that in Gel Implants.
- Saline Implants had no cases of Seroma and no cases of the rare malignancy ALCL.
It is interesting to note that this study being conducted in France, that the size of the implants was not overly large and ranged up to only 380cc. This size, however, would satisfy most women who were looking for a full C or D cup result. This study by the French Plastic Surgeons acts therefore serves as further confirmation that saline implants are an excellent alternative to gel implants provided the prospective patient does not want a very large Implant. The average Implant size in the French study was just over 200CC whereas the average Implant in the United States and Australia is much larger, and surgeons tend to choose gel filled implants for those patients wishing to have a larger sized breasts.
In Plastic Surgery, there is a saying, “the larger the Implant, the larger the problems”. A sensible sized implant measured in relationship to the size of the patient’s chest wall or breast footprint is the answer and generally speaking will not replicate into a Double D or E size.
Another benefit of saline implants over gel filled breast implants is that the saline implants can be inserted via a smaller incision which results in less scarring than with the gel implants. Aesthetically, saline implants are also believed to look more natural as they move more like natural breast tissue and have the “shimmy” effect of real breasts as opposed to the more solid and unnaturally firm appearance and movement of the gel implants.
Dr Hodgkinson is very comfortable using smooth walled saline implants and has a more than 20 year experience with these devices. Other benefits of saline filled versus gel filled implants beyond their proven safety is that they require a smaller incision site meaning a shorter and less perceptible scar and that they move more naturally. Regarding safety, Dr Hodgkinson has noted a similar, very low rate of problems with saline breast implants including less than 3% rupture over ten years. If a saline filled implant ruptures, it is not only immediately evident but poses less risk as any leakage is sterile saline which occurs naturally in the body as opposed to gel which is a foreign body that adheres to the tissues and can cause reactions and is difficult to remove. Replacement of a saline implant is a relatively simple procedure and the medical device company supplies a replacement implant free of charge.
The conclusion from the French study: “Smooth inflatable implants filled with saline solution have numerous advantages such as the possibility of a very small approach route and perioperative adaptability of the volume. In light of the lack of indication of anaplastic large-cell lymphoma with smooth implants, they are clearly an attractive alternative to textured implants filled with silicone gel.”
*Sorbonne Paris Cité, Service de Chirurgie Plastique, Reconstructive et Esthétique, Centre de Traitment des Brûlés, AP-HP, Hop Saint Louis, Université Paris Diderot, 1 Avenue Vellefaux, 75475 Paris, France “A 10-Year Follow-Up Experience of 383 Patients with Bilateral Smooth Inflatable Breast Implants Filled with Saline Solution”, Aesth Plast Surg (2020) 44:330-338 https://doi.org/10.1007/s00266-019-01416-3