Dutch tighten breast implant policy amid cancer danger

The Netherlands will not ban breast implants with a rough surface amid concerns that they may increase the risk of a rare form of lymph node cancer. But the Dutch government will tighten the rules for the use of implants in breast reconstruction and breast enlargements in an effort to make sure that all women who have them are as safe as possible, Minister Bruno Bruins for Medical Care said in a letter to parliament.

In April France decided to ban all breast implants that are macro-textured and have polyurethane coating due to an increased risk of a rare form of lymph node cancer. The Minister asked public health institute RIVM to assess the French documents on this topic. The RIVM concluded that there is insufficient evidence for a general relationship between rough-surface implants and an increased risk of that cancer. There is one specific implant - Biocell implants by Allergan - for which this link is plausible, but that implant has already been removed from the market.

Bruins said that he received many letters and emails from women worried about the implants they have, as well as from people and organizations worried about implants being taken off the market. He called them all moving stories.

"This presented me with a dilemma: a ban on rough implants would further limit the very small risk of this rare form of lymph node cancer, but that does not stop the unrest." He added that cancer- and patient organizations "rightly pointed out" to him that a ban will have a huge impact on the large group of women with a genetic predisposition to breast cancer. "Many of them choose - no matter how difficult it is - for the preventive removal of their breasts. I do not want to deprive them of the option to choose implants."

Based on the RIVM report, the Healthcare Inspectorate also sees insufficient evidence for increased cancer risk to remove all rough implants from the market. The Inspectorate weighed the known risks of breast implants and the need for them.

Bruins followed this same reasoning, he said. "There are risks associated with every implant." According to him, a ban will not alleviate concerns and may even lead to new problems, like women delaying a necessary surgery or going abroad for treatment. "The implants are of great value for breast cancer patients, but also for women with little or no breast formation and for trans women. The many messages I received from them keep saying that the implants help them 'to look as normal as possible'. The implants therefore contribute to their quality of life. Moreover there is no equivalent alternative."

"All things considered, I am therefore not going to ban the implants", Bruin said. Instead he, in consultation with medical professionals and involved associations and organizations, will tighten the rules on breast reconstruction and enlargement.

The Netherlands' association for plastic surgery NVPC is currently working on new guidelines on breast prosthesis surgery. This will require doctors to inform patients about all risks involved with implants and about alternative treatments. Both doctor and patient will have to sign a declaration that this was explained to them and they understand. The new guidelines will also include periodic follow-up care for all people with breast implants, so that any possible problems can be identified early.

The new guideline is expected to be ready by the end of this year. In the meantime, the NVPC will actively approach the over 60 thousand women in the Netherlands with Allergan-Biocell implants so that they can be examined.