18 November 2019 

Nagor textured breast implants: first statistical data showing cause of BIA-ALCL. Yet it is clear from other data produced by the 1st World Consensus Conference on BIA-ALCL that BIA-ALCL is not just an Allergan Biocell problem and has been linked to other manufacturers; including Mentor which has 7% and Sientra  which has 1% of cases of BIA-ALCL linked to them, to date. For more information from the 1st World Consensus Conference on BIA-ALCL First World Consensus 

 

UK regulator

 

The MHRA informs the public, via its website, that at present there are 59 confirmed cases of BIA-ALCL in the UK.It  has only taken action to ban Allergan Biocell from the UK market.

 

French regulator

 

 The ANSM has banned all textured implants, including Nagor, in April 2019;

 

Australian regulator

 

The TGA has banned 8 manufacturers – Microtextured implants:
Allergan, Nagor, Eurosilicone, Sebbin, Polyuthethane, air expanders
Microtextured – Mentor Siltex, Allergan BRST can still be used as smooth implants are not available in Australia, but with additional study requirements and scrutiny.

 

BIA-ALCL Nagor Implants & Eurosilicone:

 

 GC Aesthetics Communication latest update Posted 12/07/2019
The Australian Therapeutic Good Administration (TGA) has released a public statement of the preliminary outcomes from its review of textured implants on July 11, 2019. The notice proposes certain actions the TGA may take in relation to textured implants used in Australia. GC Aesthetics is surprised about this public statement, given the overall very low occurrence rate of BIA-ALCL compared to other medical conditions.

It is important to notice that no final decision has been taken at this stage. GCA, as well as other responsible manufacturers, are transparently communicating with TGA and stand by our robust data and clinically proven safety GC Aesthetics’ implant safety has been proven through a number of large scale, long term prospective clinical studies in over 1000 patients, including the only two large scale prospective European study of breast implants with 10-year patient follow up. With over 3 million implants sold over the last 10 years across 70 countries GCA’s safety record is quite clear:

The global rate of BIA-ALCL associated with GCA textured implants is <0.0007%
The global rate of BIA-ALCL associated with GCA smooth implants is 0%
GCA is at the forefront of the industry with a prominent and permanent focus on patient safety. We will continue to closely monitor the incidence of BIA- ALCL and participate in collaborative global research. We also remain committed to transparency with our doctors and patients about this and any other safety concerns.
Yours sincerely,
Carlos Reis Pinto CEO

 

Allergan’s Statement

July 30th, 2019, Allergan announced it would cover the costs of new implants for people with Biocell implants who want to replace them. Allergan won’t pay for surgery costs, however. The program runs until July 24, 2021.

 

Mentors Statement

Patient safety has been and always will be our priority which is why we recommend Mentor implants. MENTOR® Breast Implants are backed by substantial clinical data demonstrating safety and effectiveness in patients having undergone primary and revisionary augmentation and reconstruction surgeries. Mentor continues to support ongoing inquiries into the association of ALCL and breast implants. ALCL stands for Anaplastic large cell lymphoma, the full title is Breast Implant Associated Anaplastic large cell lymphoma (BIA-ALCL) and is an extremely rare cancerous tumour that can potentially grow around breast implants. The occurrence of ALCL effects is estimated at 1 in 24,000 breast implants (Source: Medicines and Healthcare products Regulatory Agency (MHRA) July 2018). It usually appears with a sudden swelling in the breast surrounding an implant, although it can present with a mass. It usually happens many years after the implants have been placed, an average of 8 years. Most cases are easily treated by having the implant removed, along with the capsule that surrounds it (total capsulectomy).

 

AirXpanders

 

July 26, 2019 assets will be liquidated and claims paid in accordance with its voluntary petition for relief, filed in the U.S. Bankruptcy Court for the Northern District of California on Wednesday. The company’s board of directors has been dissolved.
The decision came “after considering all strategic alternatives,” according to an SEC filing in which the company reported total assets of approximately $18.46 million and liabilities of $19.77 million. AirXpanders’ official delisting from the Australian Securities Exchange will likely occur by the end of September, the filing said.

San Jose, California-based medical device company AirXpanders, which entered the U.S. market in 2017 with a De Novo for its soft tissue expansion system used in breast reconstruction, announced this week it will immediately cut the majority of its staff and file for Chapter 7 bankruptcy.

The Aeroform patient controlled tissue expander was on the Therapeutic Goods Administration’s July 11 list of breast implant products up for suspension following regulators’ review of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).

 

Harley Medical Group Statement from Simon Smith, Medical Director

“BIA-ALCL is very rare – estimated at 1 in 24,000 breast implants, and can affect women having implants placed for cosmetic or reconstructive reasons. It seems likely that few women are likely to change their mind about implants, but they should have full awareness of this condition before agreeing to implants, as part of their consent process.

Women who have implants already, certainly should not be alarmed, but if they get a sudden swelling in their breasts, they should seek a referral from their GP to their local breast unit, who will follow guidelines set down by the ABS to ensure that there is no underlying serious cause for it. Treatment for BIA-ALCL is usually simple and successful, but it must be actively managed.”

 

Transform Cosmetic and Medical Aesthetics

Information on site

What is ALCL?

Anaplastic Large Cell Lymphoma (ALCL) is an extremely rare type of non-Hodgkin’s lymphoma (NHL), a cancer involving the cells of the immune system. ALCL can affect 1 in 24,000 women who have breast implants. It is important to emphasise the extremely low probability of ALCL occurring in women with breast implants. Instances of Breast Implant Associated ALCL generally occur several years after the breast implant surgery; on average, 8 years following the procedure. The majority of cases are easily treated by removing both the implant and the surrounding capsule, known as a total capsulectomy. Breast enlargement patients will be made fully aware of the condition as part of the consent process before having their procedure.

 

Worried about ALCL-BIA?

 

I have Allergan implants that have now been withdrawn from the worldwide market due to a link with this type of cancer and I am keeping them. For more information about Breast, Implant Manufacturers go to Manufacturers

For access to plastic surgeons and support please join my linked in group  Linkedin Group

 

Previous Banned implants

 

P.I.P Breast Implants

 

P.I.P breast implants were banned worldwide in 2010. This was due to unauthorised use of non-medical grade silicone in their implants.

Companies and consultants that used P.I.P implants were completely unaware that they were filled with non-medical grade silicone. The implants had a CE mark to guarantee quality and they were also used by the NHS. However cosmetic surgery companies and consultants that used them do now have a responsibility to their patients to remove and replace them if required.

PIP implants with non medical grade silicone are more prone to ruptures and the silicone can the travel around your body which may lead to serious health consequences.

If you have or think you may have P.IP implants check with your consultant when they were manufactured and if after 2010 the general consensus is to have them removed immediately.

Companies that used PIP implants 

 

include and are not limited to:

NHS
Transform offered to remove and replace all P.I.P implants without charge.

Harley Medical Group only offered to remove and replace ruptured implants. There was a national outcry from women who had P.I.P implants filled with industrial silicone that could rupture at any time.

 

Soya – Trilucent implants

 

Trilucent (soya bean oil filled) breast implants manufactured by Lipomatrix Inc. Subsequently, the product liability was taken on by Collagen Aesthetics International and then by AEI Inc. These implants were withdrawn from use in the UK in March 1999.
This was due to unexpected complications with the soya oil transfusing through the silicone shell and higher rupture rates.

 

Companies that used Soya, Trilucent implants

 

 

Include and are not limited to:

NHS
Transform
Harley Medical

 

Hydrogel – Novagold or Clover Leaf Products

 

Hydrogel Implants manufactured by Novagold or Clover Leaf Products were banned worldwide in December 2000.
This was due to unexpected complications with the hydrogel transfusing through the silicone shell and higher rupture rates.
If you have or think you may have hydrogen Implants manufactured by Novagold or Clover Leaf Products, check with your consultant, the general consensus is to have them removed immediately.

Companies that used Hydrogel Implants 

 

manufactured by Novagold or Clover Leaf Products include and are not limited to:

NHS
Transform
Harley Medical

Currently, the only alternative to silicone or saline-filled implants is hydrogel implants.

 

Manufactured by Laboratories Arion, they are called Monobloc Hydrogel CMC breast implants and are the only hydrogel implants available with a CE mark. (Not approved for use by the FDA.)
Manufactured in France and Europe, the ranges Monobloc CMC Hydrogel and the ranges Monobloc Silicone from the Laboratoires Arion have obtained the CE marking issued by the independent inspection body LNE GMED and are authorized by the AFSS.

Breast Implant Range: Expandable, Anatomical implants and non-anatomical implants: standard round and an oval base.Profiles: low, medium, and high.   http://www.laboratoires-arion.com/

 

 

For more information about:

Revision surgery go to Revision Surgery
Breast reconstruction without implants go to  Reconstruction without implants