Breast Implants & # 39; Allergan & # 39; related to a rare type of cancer removed

The US Food and Drug Administration (FDA) asked the company today Allergan who remove several models of her textured bad implants suspected of cause a rare type of cancer called Anaplastic large cell lymphoma (LACG) badociated with bad implants. This request came almost four months after France – and later Australia and Canada – vetoed this type of prosthesis.

At the request of the Administration, Allergan notified the FDA that it was proceeding with a worldwide voluntary withdrawal – including from Argentina – of its products. Textured Biocell bad implants, which include: Natrelle bad implants with saline solution, Natrelle silicone filled implants, Natrelle Inspira silicone filled implants and Natrelle 410 bad implants with high anatomical cohesion. The elimination also includes tissue expanders used by patients prior to bad augmentation or reconstruction, including Natrelle 133 Plus tissue expander and Natrelle 133 Plus tissue expander with sutures.

A shocking diagnosis: "My bad implants have given me cancer"

According to the latest FDA data, 573 cases of LACG and 33 deaths due to this type of rare cancer have been reported worldwide. Of these, 481 cases were attributed to Allergan implants. Of the 33 deaths of patients reported by the Administration, only the manufacturer of the prostheses is known in 13 cases. The FDA found that 12 of these 13 patients had an Allergan bad implant at the time of diagnosis.. "Based on currently available information, including new data, our badysis demonstrates that the risk of LACG with Allergan Biocell textured implants is approximately six times higher than that of LACG with textured implants from other manufacturers marketed in the US. "The FDA said in a statement.

"Although most cases of BIA-ALCL are badociated with the use of textured bad implants, particularly textured macro-implants, such as those made by Allergan, we are continuing our badessment to determine whether the risk of GLG is limited to models. specific, "said FDA Vice President Amy Abernethy. Despite the removal of textured Biocell prostheses, the FDA has not recommended the removal or replacement of these types of bad implants or other types of bad implants because of the low risk to develop GLG.

According to the WHO, anaplastic large cell lymphoma (LACG) badociated with bad implants is not a bad cancer or bad tissue, but a tumor of the lymphatic system. In very rare cases, it can develop near the bad prosthesis (a case is estimated every 30,000). The disease usually presents itself in the form of a build-up of fluid around the prosthesis (late seroma) or a tumor in contact with the implant. Most cancers have developed on average eight years after implantation.

In Argentina, to date, nine cases of GLG and one death have been reported.. In October 2018, PROFILE reported the first case diagnosed in the country: Valeria Olveira.. Allergan is the third largest prosthetic company in the country. As he could tell PROFILE, distributing the brand in Argentina, removed all textured prostheses in stock after the decision of the company.

Recognize that bad implants can have serious side effects

"Women should not panic, nowhere in the world are bad implants removed or replaced. Statistics show a very low incidence of one in every 30,000 women, "said plastic surgery specialist Jorge Pedro, director of communication at the Argentine Society of Plastic, Aesthetic and Reconstructive Surgery (Sacper). "The LACG is a very rare disease.Of 600 000 prostheses implanted in the last ten years in Argentina, eight or nine cases were reported and 573 out of a total of 10 to 15 million implanted women were implanted in the world" , he added.

"Lymphoma is a tumor of the capsule that covers the bad implant, not the bad, and has also been observed in capsules covering other types of implants in the body, such as the hip. a sharp increase in the fluid around the implant, an abrupt height increase in a bad, a redness or an increase in pain, "Pedro said.

Despite the low risk, prosthetic patients must follow their clinical clinical examination of the bad and carry out the usual studies (mammography, ultrasound, magnetic resonance imaging) as well as those who do not have an implant and in case of symptoms such as swelling, liquid formation (seroma) or sudden change in shape and / or size, consult the professional immediately to eliminate the disease. The specialist stated that scientific evidence continues to demonstrate the safety of bad implant surgery, whether for reconstructive or cosmetic purposes, provided that it is performed by certified health professionals, in spaces authorized for this purpose and with quality products approved by Anmat and FDA