FDA's dramatic warning, about breast augmentation: what are the meanings and alternatives?

Following the FDA's dramatic warning - a steep increase in requests to plastic surgery clinics from women who underwent breast augmentation:   what are the meanings and alternatives?

  (photo credit: PR)
(photo credit: PR)

A steep increase in applications to plastic surgery clinics from women who have undergone breast augmentation, due to the severe warning issued by the FDA and the World Health Organization: "Silicone implants with a textured outer shell may cause cancer - and even lead to death;" and news that the "FDA prohibits breast implants made of textured silicone due to specific cancer cases found among women" (anaplastic large cell lymphoma (ALCL).

In Israel, too, the regulation was received and women are called to come to clinics to perform a condition assessment and examination.

Already since the ’80s there have been many warnings and rumors that silicone implants used in breast augmentation surgeries may cause cancer, leak, and cause severe damage after breast augmentation. Since then, this has not stopped the industry from growing and developing. Millions of women in Israel and around the world continued to undergo a surgical procedure for breast augmentation and even the practice of replacing the implants after several years was introduced. Over the years, other types of implants have also been developed, designed to overcome the shortcomings of texture implants.

It turns out there was something to that, and all the warnings, concerns, and statements regarding silicone implants as a cause of a greater chance of getting cancer were not unfounded. Many women will surely remember the panic that the French minister of health provoked in 2011 when he warned and asked 30,000 women who had undergone textured silicone implants to urgently go to the doctor and have them removed. Today it is clear! Textured silicone implants are a decisive factor in the fact that women have developed cancer of the anaplastic large cell lymphoma (ALCL) type. This is exactly why the American FDA has issued a new unequivocal announcement about the prohibition of using textured breast implants, and states that going to surgery to remove textured implants is a reasonable step. Israel is also adopting the decision and calling on women to come to clinics for consultation with a plastic surgeon.

Dr. Guy Rasner, an expert in plastic surgery and a senior physician in the body contouring unit at Sheba Tel Hashomer, explains that after the FDA issued a change of position, which means that in light of the data gathered in the committees and discussions held, the doctors decided that the removal of textured implants is a reasonable decision. This means that the FDA recommends that the textured implants be removed because the recurrence of a specific type of cancer only occurs in women whose bodies were implanted with textured implants.

  (credit: PR)
(credit: PR)

In Israel, it was decided to adopt the recommendations and this continues the line of also recommending the removal of textured implants, alongside a recommendation to choose other types of implants, which are not associated with these complications.

From the point of view of Israeli patients, this means that for those who have textured implants, or those who do not know which implants they have, or their body has implants that have not been examined for several years, it is recommended to go see a plastic surgeon who is a member of the Association of Plastic Surgeons to conduct a personal investigation. Member plastic surgeons are constantly updated on the most recent guidelines of the FDA and act according to them.

The textured implants are on a scale of implants since not every textured implant carries the same risk of developing cancer. The specific implants for which the connection to breast cancer was revealed have been out of use ever since it was revealed, around the year 2017.

Until then, these were popular implants in the world and Israel. In Israel, there are thousands of women with such implants and other different types of implants, but the recommendation is to remove any textured implants.

From here, the overwhelming recommendation is to get an individual consultation with an expert in plastic surgery and to consider all the individual considerations of that patient.

In any case, the blanket recommendation is to replace the implants every 10-15 years.

What are the other options for breast augmentation today? Yes, it is still one of the most popular operations in the world in the field of plastic surgery.

Women who are considering breast augmentation should consider using smooth implants, or implants with an advanced fine texture. For example, Motiva implants are considered advanced smooth implants, and the development of this cancer has never been reported in them.

Motiva - advanced smooth breast implants - led the women's health agenda:

Motiva's implants are a newer and more advanced generation, produced with a technology that is completely different from the textured technology, with a completely different method of production and texture, and this joins their other health properties, to the fact that they are soft and comfortable, and are rated as highly satisfied by patients and doctors.

One of the alternatives that has become a favorite in breast reconstruction surgery in hospitals is the Motiva implants that led the health agenda in breast implants, which are considered advanced parts and are thus considered groundbreaking in the health aspect. Motiva places a special emphasis first on deepening and raising awareness of breast cancer and on the development of ergonomic health implants, which are already known all over the world.

The Ergonomix implant series is a series that is preferred and selected mainly in breast reconstruction surgeries and the reason lies in the fact that this series was developed mainly to answer those women who have to undergo breast reconstruction. This is a breakthrough, the starting point of women's health, of a development born from a health aspect, to provide for those women who want to enlarge their breasts and/or restore their breasts after cancer.

Motiva implants are almost free of complications and account for less than 1% of complications in all implants. This is also the reason why many plastic surgeons choose these implants. The ergonomic implants are sold in more than 80 countries worldwide, and even after more than 2 million implants have been sold, Motiva continues to present less than 1% complications. These implants are inserted using the unique minimal-scar technique developed following the ergonomic implants in which a smaller incision can be made in the skin to insert the ergonomic implants into the body thanks to their flexibility. This makes it possible to make an incision half the size of the conventional incisions and due to the natural ergonomic structure of Ergonomix implants, their shell is exclusive in nanotechnology, a technology that has been tested and proven through many studies all over the world that this shell is the most friendly and healthy for the woman's body.